Chronic Insomnia
Conditions
Keywords
cognitive-behavioral psychotherapy, online Intervention, cost-effectiveness, chronic insomnia
Brief summary
The proposed parallel-group randomized controlled trial add-on superiority of the iCBT-I program with CAU as a control condition will let us investigate the effectiveness and cost-effectiveness of iCBT-I. Analysis of baseline characteristics of the participants aims to find predictors of outcome
Detailed description
Application of internet-delivered cognitive-behavior treatment for insomnia (iCBT-I) is a perspective method that can fill the gap created by the discrepancy between insomnia cases and the number of trained professionals. Although the effectiveness of this method was proven in multiple studies conducted in research settings, it is unclear if iCBT-I outperforms pharmacotherapy which remains a widely used alternative of cognitive-behavior therapy of insomnia (CBT-I). Predictors, mediators, and moderators of treatment effect remain uncertain since previous studies often give contradictory results. The present study aims to investigate clinical effectiveness and cost-effectiveness of an internet-based CBT-I program Sleepsy in comparison with care as usual (CAU) among patients with chronic insomnia (CI) recruited from clinical settings. Baseline data will be further analyzed to find predictors of treatment outcome For these purposes, a parallel-group randomized controlled trial add-on superiority of the iCBT-I program with CAU as a control condition was designed. 110 participants will be referred from the medical doctors in Moscow. Both groups will have access to CAU, treatment prescribed by the referred doctor. Patients of the first group will additionally get access to the iCBT-I program with the opportunity to contact a specialist within the program (guidance on request) in a secured environment. The primary outcome is insomnia severity change from pre- to posttreatment and to post-follow-up. Secondary outcomes include change subjective sleep characteristics, daytime symptoms, comorbid affective disorders, dysfunctional cognitions and behavior, healthcare consumption, and productivity losses. Predictors analysis will include baseline scores of the aforementioned outcomes along with treatment expectancies, personality traits To the best of our knowledge, the present study is the first study of iCBT-I to be conducted in clinical settings. We expect that this approach lets us determine the target group more precisely and exclude health problems that may interfere with treatment. It is also expected that patients, referred to iCBT-I from the doctor's office will be more motivated to finish the treatment course that will reduce the drop out rate. CAU as control condition let us reconstruct clinical situation facing practicing doctor. On the other hand, CAU may result in a loss of power to detect a meaningful difference. Limitation of our study is in the impossibility of blinding participants to the treatment condition
Interventions
BEHAVIORALinternet-delivered cognitive-behavioral therapy for insomnia (iCBT-I)
The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study.
OTHERCare as usual (CAU)
Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers. All concurrently applied treatments will be assessed repeatedly by self-report
Sponsors
University of Bern
I.M. Sechenov First Moscow State Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Multicenter parallel-group add-on superiority randomized controlled trial (RCT) comparing an active treatment condition (iCBT-I plus CAU) to CAU alone
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Sleep disorder matching chronic insomnia criteria (International Classification of Sleep Disorders-3) - assessed by clinical judgement * Ability to follow the procedures of the study, fluent Russian language, Good access to internet - assessed by self-report
Exclusion criteria
* Presence of dementia (identified by history or a score \< 25 on the Folstein Mini Mental Status Exam) - assessed by clinical judgement * Severe depression or severe anxiety as measured with the Beck Depression Inventory (BDI-II; score \> 28 ) and the Beck Anxiety Inventory (BAI; score \> 26) - assessed by the questionnaires * History of severe psychiatric comorbidities other than anxiety and depression (bipolar disorders, psychotic disorders) or substance use disorder - assessed by self-report and clinical history * Untreated severe obstructive sleep apnea syndrome (apnea-hypopnea index (AHI) \> 15), restless legs syndrome (movement index with arousal \> 15 per hour) or other sleep disorders affecting night sleep - assessed by clinical judgement and clinical history * pregnancy, lactation - assessed by self-report * having a serious somatic condition or brain disorders (stroke, Parkinson's disease…) preventing further participation - assessed by self-report * Having high suicidality risk - assessed by clinical judgement, high total BDI-II score (\> 29) or score \>1 on a BDI-II of suicidality subscale
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | pre- to post-treatment 2 months, pre-treatment to follow-up 5 months | Change of ISI from pre- to post-treatment and post-follow-up. Change is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of insomnia severity. The ISI is a seven-item insomnia assessment tool. The 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Sleep Time (TST) | pre- to post-treatment 2 months, pre-treatment to follow-up 5 months | Sleep diary derived measure averaged for 1 week pre- post-treatment, post-follow-up. For the purposes of effectiveness investigation change of TST from pre- to post-treatment and post-follow-up. Change of TST is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the worse outcome, negative values correspond to the better outcome, i.e. increase of total sleep time |
| Sleep Efficiency (SE) | pre- to post-treatment 2 months, pre-treatment to follow-up 5 months | Sleep diary derived measure calculated as the ratio of TST to time spent in bed multiplied by 100%, averaged for 1 week pre- post-treatment, post-follow-up. For the purposes of effectiveness investigation change of SOL from pre- to post-treatment and post-follow-up. Change of SE is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the worse outcome, negative values correspond to the better outcome, i.e. increase of sleep efficiency |
| Wake After Sleep Onset (WASO) | pre- to post-treatment 2 months, pre-treatment to follow-up 5 months | Sleep diary derived measure averaged for 1 week pre- post-treatment, post-follow-up. For the purposes of effectiveness investigation change of WASO from pre- to post-treatment and post-follow-up. Change of WASO is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of the time spent awake after sleep onset |
| Fatigue Severity Scale (FSS) | pre- to post-treatment 2 months, pre-treatment to follow-up 5 months | Disorder non-specific 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle. Each item is evaluated on the 7 points Likert scale (e.g., 1 indicates strongly disagree and 7=strongly agree.), yielding a total score ranging from 9 to 63. A higher score reflects a higher level of fatigue. Change of FSS was calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of fatigue |
| Short-form Survey (SF-12 Version 1.0) | pre- to post-treatment 2 months, pre-treatment to follow-up 5 months | The Short Form Survey (SF-12)is calculated as a summary of the mental component score (MCS-12) and a physical component score (PCS-12). Total score ranges from 0 to 100, with higher scores indicating better functioning. The subscale scores are represented as T-scores with a mean of 50 and a standard deviation of 10 in the general population. A score of \< 50 on the PCS-12 is a cut-off to determine a physical condition; score of \<42 on the MCS-12 may be indicative of 'clinical depression'. For this study we used change of the SF-12 total score as outcome. Change of SF-12 is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the worse outcome, negative values correspond to the better outcome, i.e. increase of physical and mental health functioning |
| Epworth Sleepiness Scale (ESS) | pre- to post-treatment 2 months, pre-treatment to follow-up 5 months | Measure asking propensity for 'dosing' in eight daytime situations from 0 = never to 3= very high propensity, yielding a total score ranging from 0 to 24 with normal score \< 9. Change of ESS is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of daytime sleepiness |
| Beck Anxiety Inventory (BAI) | pre- to post-treatment 2 months, pre-treatment to follow-up 5 months | 21-questions inventory with a 4-point Likert scale and ranging answers from 0 to 3, yielding a total score ranging from 0 to 63. A BAI total score higher than 25 corresponds to severe anxiety. Change of BAI is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of anxiety |
| Beck Depression Inventory (BDI-II) | pre- to post-treatment 2 months, pre-treatment to follow-up 5 months | 1-questions inventory with a 4-point Likert scale and ranging answers from 0 to 3, yielding a total score ranging from 0 to 63. A BDI cutoff higher than 28 indicates severe depression. Change of BDI-II is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of depression |
| Sleep Hygiene Index (SHI) | pre- to post-treatment 2 months, pre-treatment to follow-up 5 months | 13-questions questionnaire evaluating each item on a 5-point Likert scale, yielding a total score ranging from 13 to 65. Higher SHI score corresponds to the worse sleep hygiene. Change of SHI is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. worsening of sleep hygiene habits |
| Sleep Locus of Control Questionnaire (SLC) | pre- to post-treatment 2 months, pre-treatment to follow-up 5 months | variant validated in Russia comprises 8 questions scored using a 6-point Likert scale ranging each answer from 1 = strongly disagree; 6 = strongly agree, yielding a total score ranging from 8 to 48. The Russian adaptation of the scale has shown internal reliability of 0.41. Higher SLC score corresponds to the more marked external locus of control. Change of SLC is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. more prominent external locus of control of sleep |
| Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS) | pre- to post-treatment 2 months, pre-treatment to follow-up 5 months | designed to identify and assess the severity of various sleep and insomnia-related cognitions. It consists of 16 questions with a Likert scale ranging answers from 0 = strongly disagree to 10 = strongly agree with a total score ranging from 0 to 160. Higher DBAS score reflects more severe dysfunctional thinking. The Russian adaptation of the scale has high internal reliability of 0.86. Change of DBAS is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. more prominent dysfunctional beliefs about sleep |
| Anxiousness Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Anxiousness is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Health Care Consumption | pre- to post-treatment 2 months, pre-treatment to follow-up 5 months | This measure aims to evaluate the cost-effectiveness of iCBT-I. The first part of TIC-P consists of 14 questions on the volume of health care uptake: including the number of medical consultations, dose, and frequency of medication, days of inpatient care. Multiplication of these data by the actual price of medical help produces the cost of medical care as the outcome. The higher outcome represents higher costs of medical care. Change of TiC-P Health care consumption is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. higher costs of the healthcare consumption |
| Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Short Form- Health and Labour Questionnaire (SF-HLQ) | pre- to post-treatment 2 months, pre-treatment to follow-up 5 months | This measure aims to evaluate the cost-effectiveness of iCBT-I. The second part of TIC-P is represented by the Short Form- Health and Labour Questionnaire (SF-HLQ), an instrument to collect data on productivity losses (presenteeism and absenteeism) due to health problems. Costs of productivity losses are calculated by multiplication of missed working hours by standard cost price of productivity. The higher outcome represents higher costs of productivity losses. Change of TiC-P productivity losses is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. higher costs of the productivity losses |
| Success Expectancy | Once at baseline assessment | Aims to measure patients' beliefs about the expected treatment success as one of the important outcome predictors. For its evaluation we will use one adapted question of Credibility/Expectancy Questionnaire: At this point, how successfully do you think this treatment will be in reducing your insomnia symptoms? at scale from 1 to 9. This question was chosen as well representing high correlation for both factors: credibility and expectancy, and most logically formulated for the intended purpose |
| User Satisfaction | After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU | feedback questionnaire developed for this study. It includes 1 question about satisfaction or dissatisfaction with the treatment with a 5-point Likert scale, from 1 (very poor/not at all useful) to 5 (very, good/very useful). The questionnaire also contains open questions aiming for utilitarian goals, i.e. to improve the program (possible negative effects of the intervention if any: deterioration of insomnia symptoms, adverse effects, novel symptoms; and about improvement suggestions, what participants liked most if they would recommend it to a friend with insomnia). These questions are not included in questionnaire score |
| System Usability Scale (SUS) | After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU | 10-item non-specific questionnaire used to collect a user's subjective rating of a product's (products, websites, applications, hardware, or software) usability and learnability. Each item is scored on a scale of 0 (strongly Disagree) to 4 (strongly Agree). For positively-worded items (1, 3, 5, 7 and 9), the score contribution is the scale position minus 1. For negatively-worded items (2, 4, 6, 8 and 10), it is 5 minus the scale position. To get the overall SUS score, multiply the sum of the item score contributions by 2.5. Thus, SUS scores range from 0 to 100 in 2.5-point increments. Higher SUS score reflects better subjective usability of the program. |
| Number of Completed Modules | After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU | Measure of adherence. Program-derived outcome measuring, how many modules were completed (i.e. videolecture, answers to the questions after videolecture) |
| Total Time Spent on the iCBT-I Website | After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU | measure of adherence. Program-derived outcome |
| Time Spent on Each Module | After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU | measure of adherence. Program-derived outcome |
| Number of Completed Sleep Diaries | After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU | measure of adherence. Program-derived outcome |
| Usage of the Support | After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU | number of referrals to the supporting psychologist through the feedback form. Program-derived outcome |
| Attention Seeking From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Attention seeking is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Callousness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Callousness is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Deceitfulness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Deceitfulness is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Depressivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Depressivity is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Distractability From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Distractability is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Eccentricity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Eccentricity is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Emotional Lability From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Emotional lability is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Grandiosity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Grandiosity is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Hostility From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Hostility is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Impulsivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Impulsivity is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Intimacy Avoidance From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Intimacy avoidance is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Irresponsibility From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Irresponsibility is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Manipulativeness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Manipulativeness is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Perceptual Dysregulation From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Perceptual dysregulation is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Perseveration From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Perseveration is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Restricted Affectivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Restricted affectivity is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Rigid Perfectionism From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Rigid perfectionism is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Risk Taking From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Risk taking is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Sleep Onset Latency (SOL), | pre- to post-treatment 2 months, pre-treatment to follow-up 5 months | Sleep diary derived measure averaged for 1 week pre- post-treatment, post-follow-up. For the purposes of effectiveness investigation change of SOL from pre- to post-treatment and post-follow-up. Change of SOL is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of sleep latency |
| Submissiveness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Submissiveness is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Suspiciousness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Suspiciousness is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Unusual Beliefs Experience From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Unusual beliefs experience is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Withdrawal From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Withdrawal is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Anhedonia From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Anhedonia is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
| Separation Insecurity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | Once at baseline assessment | 100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Separation insecurity is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet |
Countries
Russia
Participant flow
Recruitment details
115 patients with chronic insomnia fulfilling ICSD-3 criteria referred from neurologists specialized in somnology in Moscow (Sleep Medicine department, University Clinic 3, Sechenov First Moscow State Medical University, Moscow) from March 2020 to December 2022 were assessed for eligibility
Participants by arm
| Arm | Count |
|---|---|
| iCBT-I + CAU Demographic characteristics and baseline clinical scores for the study sample were compared with t-test and Chi-square test. iCBT-I + CAU group participants were significantly younger:median (IQR) = 37 (28-50); and had lower FSS: mead (SD) = 36.2 (15.4) Medications used for the management of insomnia included benzodiazepines and hypnotic benzodiazepine receptor agonists, sedating antidepressants, antipsychotics, antihistamines, melatonin, phytotherapy, and off-label substances | 53 |
| Care as Usual (CAU) Demographic characteristics and baseline clinical scores for the study sample were compared with t-test and Chi-square test. iCBT-I + CAU group participants were significantly older: median (IQR) = 40.5 (34.2-60.5); and had higher FSS: mead (SD) = 43.2 (12.4). Medications used for the management of insomnia included benzodiazepines and hypnotic benzodiazepine receptor agonists, sedating antidepressants, antipsychotics, antihistamines, melatonin, phytotherapy, and off-label substances. | 54 |
| Total | 107 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 8 |
Baseline characteristics
| Characteristic | Care as Usual (CAU) | Total | iCBT-I + CAU |
|---|---|---|---|
| Age, Continuous | 40.5 years | 40 years | 37 years |
| BAI - Beck anxiety inventory | 10.3 units on a scale STANDARD_DEVIATION 7.4 | 9.5 units on a scale STANDARD_DEVIATION 7.1 | 8.7 units on a scale STANDARD_DEVIATION 6.9 |
| BDI - Beck depression inventory | 12.4 units on a scale STANDARD_DEVIATION 6.5 | 11.6 units on a scale STANDARD_DEVIATION 6.2 | 10.7 units on a scale STANDARD_DEVIATION 5.7 |
| DBAS - dysfunctional beliefs about sleep scale | 109.8 units on a scale STANDARD_DEVIATION 22.5 | 105.6 units on a scale STANDARD_DEVIATION 24.5 | 101.2 units on a scale STANDARD_DEVIATION 25.8 |
| Duration of insomnia | 48 months | 36 months | 36 months |
| ESS - epworth sleepiness scale | 5.5 units on a scale STANDARD_DEVIATION 3.9 | 5.2 units on a scale STANDARD_DEVIATION 4 | 4.8 units on a scale STANDARD_DEVIATION 4.1 |
| FSS - fatigue severity scale | 43.2 units on a scale STANDARD_DEVIATION 12.4 | 39.8 units on a scale STANDARD_DEVIATION 14.3 | 36.2 units on a scale STANDARD_DEVIATION 15.4 |
| ISI - insomnia severity index | 15.4 units on a scale STANDARD_DEVIATION 3.9 | 15.4 units on a scale STANDARD_DEVIATION 4 | 15.4 units on a scale STANDARD_DEVIATION 4.2 |
| LCS - locus control of sleep scale | 41.7 units on a scale STANDARD_DEVIATION 14 | 42.0 units on a scale STANDARD_DEVIATION 12.9 | 42.2 units on a scale STANDARD_DEVIATION 11.8 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Russia | 54 participants | 107 participants | 53 participants |
| SE - sleep effectiveness | 78.9 percentage of time in bed spent asleep STANDARD_DEVIATION 11.1 | 77.2 percentage of time in bed spent asleep STANDARD_DEVIATION 12.1 | 75.4 percentage of time in bed spent asleep STANDARD_DEVIATION 12.8 |
| Sex: Female, Male Female | 32 Participants | 62 Participants | 30 Participants |
| Sex: Female, Male Male | 22 Participants | 45 Participants | 23 Participants |
| SF-12 - quality of life short-form survey | 31.1 units on a scale STANDARD_DEVIATION 5.5 | 31.4 units on a scale STANDARD_DEVIATION 5.6 | 31.7 units on a scale STANDARD_DEVIATION 5.6 |
| SHI - sleep hygiene index | 47.5 units on a scale STANDARD_DEVIATION 6.8 | 47.6 units on a scale STANDARD_DEVIATION 7.5 | 47.7 units on a scale STANDARD_DEVIATION 8.2 |
| SOL - sleep onset latency | 45.2 minutes STANDARD_DEVIATION 39.6 | 43.0 minutes STANDARD_DEVIATION 34.6 | 40.7 minutes STANDARD_DEVIATION 28.7 |
| TST - total sleep time | 6.8 hours STANDARD_DEVIATION 1.6 | 6.7 hours STANDARD_DEVIATION 1.4 | 6.7 hours STANDARD_DEVIATION 1.6 |
| Use of benzodiazepines and/or Z-drugs for insomnia, n (%) | 14 Participants | 33 Participants | 19 Participants |
| Use of medications for insomnia, n (%) | 42 Participants | 89 Participants | 47 Participants |
| WASO - wake after sleep onset | 32.6 minutes STANDARD_DEVIATION 35.2 | 36.5 minutes STANDARD_DEVIATION 39.4 | 40.5 minutes STANDARD_DEVIATION 43.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 54 |
| other Total, other adverse events | 0 / 53 | 0 / 54 |
| serious Total, serious adverse events | 0 / 53 | 0 / 54 |
Outcome results
Primary
Insomnia Severity Index (ISI)
Change of ISI from pre- to post-treatment and post-follow-up. Change is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of insomnia severity. The ISI is a seven-item insomnia assessment tool. The 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28)
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT-I + CAU | Insomnia Severity Index (ISI) | change from pre- to post-treatment | 10.0 units on a scale | Standard Deviation 5.1 |
| iCBT-I + CAU | Insomnia Severity Index (ISI) | change from pre-treatment to follow-up | 11.3 units on a scale | Standard Deviation 5.7 |
| Care as usual (CAU) | Insomnia Severity Index (ISI) | change from pre- to post-treatment | 13.5 units on a scale | Standard Deviation 5.5 |
| Care as usual (CAU) | Insomnia Severity Index (ISI) | change from pre-treatment to follow-up | 13.1 units on a scale | Standard Deviation 5.7 |
Secondary
Anhedonia From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Anhedonia is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Anhedonia From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.69 units on a scale | Standard Error 0.59 |
| Care as usual (CAU) | Anhedonia From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.89 units on a scale | Standard Error 0.54 |
Secondary
Anxiousness Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Anxiousness is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Anxiousness Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 2.43 score on a scale | Standard Error 0.84 |
| Care as usual (CAU) | Anxiousness Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 2.62 score on a scale | Standard Error 0.75 |
Secondary
Attention Seeking From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Attention seeking is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Attention Seeking From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 2.24 units on a scale | Standard Error 0.89 |
| Care as usual (CAU) | Attention Seeking From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 2.04 units on a scale | Standard Error 0.77 |
Secondary
Beck Anxiety Inventory (BAI)
21-questions inventory with a 4-point Likert scale and ranging answers from 0 to 3, yielding a total score ranging from 0 to 63. A BAI total score higher than 25 corresponds to severe anxiety. Change of BAI is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of anxiety
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT-I + CAU | Beck Anxiety Inventory (BAI) | Change from pre- to post-treatment | 7.0 units on a scale | Standard Deviation 6.4 |
| iCBT-I + CAU | Beck Anxiety Inventory (BAI) | Change from pre-treatment to follow-up | 8.3 units on a scale | Standard Deviation 7.9 |
| Care as usual (CAU) | Beck Anxiety Inventory (BAI) | Change from pre- to post-treatment | 9.8 units on a scale | Standard Deviation 7.7 |
| Care as usual (CAU) | Beck Anxiety Inventory (BAI) | Change from pre-treatment to follow-up | 9.3 units on a scale | Standard Deviation 7.6 |
Secondary
Beck Depression Inventory (BDI-II)
1-questions inventory with a 4-point Likert scale and ranging answers from 0 to 3, yielding a total score ranging from 0 to 63. A BDI cutoff higher than 28 indicates severe depression. Change of BDI-II is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of depression
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT-I + CAU | Beck Depression Inventory (BDI-II) | Change from pre- to post-treatment | 6.7 units on a scale | Standard Deviation 5.2 |
| iCBT-I + CAU | Beck Depression Inventory (BDI-II) | Change from pre-treatment to follow-up | 8.0 units on a scale | Standard Deviation 6.2 |
| Care as usual (CAU) | Beck Depression Inventory (BDI-II) | Change from pre- to post-treatment | 10.2 units on a scale | Standard Deviation 5.4 |
| Care as usual (CAU) | Beck Depression Inventory (BDI-II) | Change from pre-treatment to follow-up | 10.3 units on a scale | Standard Deviation 7 |
Secondary
Callousness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Callousness is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Callousness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.26 units on a scale | Standard Error 0.37 |
| Care as usual (CAU) | Callousness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.33 units on a scale | Standard Error 0.44 |
Secondary
Deceitfulness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Deceitfulness is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Deceitfulness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.49 units on a scale | Standard Error 0.48 |
| Care as usual (CAU) | Deceitfulness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.57 units on a scale | Standard Error 0.45 |
Secondary
Depressivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Depressivity is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Depressivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.23 units on a scale | Standard Error 0.34 |
| Care as usual (CAU) | Depressivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.43 units on a scale | Standard Error 0.44 |
Secondary
Distractability From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Distractability is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Distractability From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 2.10 units on a scale | Standard Error 0.73 |
| Care as usual (CAU) | Distractability From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 2.27 units on a scale | Standard Error 0.77 |
Secondary
Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS)
designed to identify and assess the severity of various sleep and insomnia-related cognitions. It consists of 16 questions with a Likert scale ranging answers from 0 = strongly disagree to 10 = strongly agree with a total score ranging from 0 to 160. Higher DBAS score reflects more severe dysfunctional thinking. The Russian adaptation of the scale has high internal reliability of 0.86. Change of DBAS is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. more prominent dysfunctional beliefs about sleep
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT-I + CAU | Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS) | change from pre- to post-treatment | 75.3 units on a scale | Standard Deviation 31.5 |
| iCBT-I + CAU | Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS) | change from pre-treatment to follow-up | 76.1 units on a scale | Standard Deviation 33.6 |
| Care as usual (CAU) | Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS) | change from pre- to post-treatment | 95.8 units on a scale | Standard Deviation 27.2 |
| Care as usual (CAU) | Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS) | change from pre-treatment to follow-up | 99.3 units on a scale | Standard Deviation 27.7 |
Secondary
Eccentricity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Eccentricity is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Eccentricity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.67 units on a scale | Standard Error 0.8 |
| Care as usual (CAU) | Eccentricity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.62 units on a scale | Standard Error 0.71 |
Secondary
Emotional Lability From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Emotional lability is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Emotional Lability From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.70 units on a scale | Standard Error 0.65 |
| Care as usual (CAU) | Emotional Lability From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.79 units on a scale | Standard Error 0.53 |
Secondary
Epworth Sleepiness Scale (ESS)
Measure asking propensity for 'dosing' in eight daytime situations from 0 = never to 3= very high propensity, yielding a total score ranging from 0 to 24 with normal score \< 9. Change of ESS is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of daytime sleepiness
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT-I + CAU | Epworth Sleepiness Scale (ESS) | change from pre- to post-treatment | 4.4 units on a scale | Standard Deviation 3.9 |
| iCBT-I + CAU | Epworth Sleepiness Scale (ESS) | change from pre-treatment to follow-up | 3.9 units on a scale | Standard Deviation 4.5 |
| Care as usual (CAU) | Epworth Sleepiness Scale (ESS) | change from pre- to post-treatment | 4.1 units on a scale | Standard Deviation 3.6 |
| Care as usual (CAU) | Epworth Sleepiness Scale (ESS) | change from pre-treatment to follow-up | 4.0 units on a scale | Standard Deviation 2.9 |
Secondary
Fatigue Severity Scale (FSS)
Disorder non-specific 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle. Each item is evaluated on the 7 points Likert scale (e.g., 1 indicates strongly disagree and 7=strongly agree.), yielding a total score ranging from 9 to 63. A higher score reflects a higher level of fatigue. Change of FSS was calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of fatigue
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT-I + CAU | Fatigue Severity Scale (FSS) | change from pre- to post-treatment | 35.1 units on a scale | Standard Deviation 14 |
| iCBT-I + CAU | Fatigue Severity Scale (FSS) | change from pre-treatment to follow-up | 33.3 units on a scale | Standard Deviation 14.9 |
| Care as usual (CAU) | Fatigue Severity Scale (FSS) | change from pre- to post-treatment | 40.6 units on a scale | Standard Deviation 13.8 |
| Care as usual (CAU) | Fatigue Severity Scale (FSS) | change from pre-treatment to follow-up | 38.3 units on a scale | Standard Deviation 15.2 |
Secondary
Grandiosity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Grandiosity is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Grandiosity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.65 units on a scale | Standard Error 0.59 |
| Care as usual (CAU) | Grandiosity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.56 units on a scale | Standard Error 0.56 |
Secondary
Hostility From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Hostility is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Hostility From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.75 units on a scale | Standard Error 0.65 |
| Care as usual (CAU) | Hostility From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 2.01 units on a scale | Standard Error 0.55 |
Secondary
Impulsivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Impulsivity is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Impulsivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.69 units on a scale | Standard Error 0.64 |
| Care as usual (CAU) | Impulsivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.63 units on a scale | Standard Error 0.57 |
Secondary
Intimacy Avoidance From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Intimacy avoidance is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Intimacy Avoidance From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.70 units on a scale | Standard Error 0.76 |
| Care as usual (CAU) | Intimacy Avoidance From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.82 units on a scale | Standard Error 0.68 |
Secondary
Irresponsibility From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Irresponsibility is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Irresponsibility From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.34 units on a scale | Standard Error 0.36 |
| Care as usual (CAU) | Irresponsibility From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.35 units on a scale | Standard Error 0.4 |
Secondary
Manipulativeness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Manipulativeness is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Manipulativeness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.65 units on a scale | Standard Error 0.52 |
| Care as usual (CAU) | Manipulativeness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.65 units on a scale | Standard Error 0.52 |
Secondary
Number of Completed Modules
Measure of adherence. Program-derived outcome measuring, how many modules were completed (i.e. videolecture, answers to the questions after videolecture)
Time frame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Number of Completed Modules | 6.54 number of completed modules | Standard Error 2.41 |
| Care as usual (CAU) | Number of Completed Modules | 4.93 number of completed modules | Standard Error 3.28 |
Secondary
Number of Completed Sleep Diaries
measure of adherence. Program-derived outcome
Time frame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Number of Completed Sleep Diaries | 6.54 number of completed modules | Standard Error 2.41 |
| Care as usual (CAU) | Number of Completed Sleep Diaries | 4.93 number of completed modules | Standard Error 3.28 |
Secondary
Perceptual Dysregulation From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Perceptual dysregulation is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Perceptual Dysregulation From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.16 units on a scale | Standard Error 0.34 |
| Care as usual (CAU) | Perceptual Dysregulation From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.14 units on a scale | Standard Error 0.27 |
Secondary
Perseveration From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Perseveration is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Perseveration From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 2.08 units on a scale | Standard Error 0.68 |
| Care as usual (CAU) | Perseveration From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 2.24 units on a scale | Standard Error 0.65 |
Secondary
Restricted Affectivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Restricted affectivity is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Restricted Affectivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.91 units on a scale | Standard Error 0.56 |
| Care as usual (CAU) | Restricted Affectivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 2.13 units on a scale | Standard Error 0.57 |
Secondary
Rigid Perfectionism From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Rigid perfectionism is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Rigid Perfectionism From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 2.21 units on a scale | Standard Error 0.61 |
| Care as usual (CAU) | Rigid Perfectionism From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 2.28 units on a scale | Standard Error 0.72 |
Secondary
Risk Taking From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Risk taking is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Risk Taking From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.50 units on a scale | Standard Error 0.56 |
| Care as usual (CAU) | Risk Taking From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.52 units on a scale | Standard Error 0.65 |
Secondary
Separation Insecurity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Separation insecurity is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Separation Insecurity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 2.24 units on a scale | Standard Error 0.7 |
| Care as usual (CAU) | Separation Insecurity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 2.49 units on a scale | Standard Error 0.69 |
Secondary
Short-form Survey (SF-12 Version 1.0)
The Short Form Survey (SF-12)is calculated as a summary of the mental component score (MCS-12) and a physical component score (PCS-12). Total score ranges from 0 to 100, with higher scores indicating better functioning. The subscale scores are represented as T-scores with a mean of 50 and a standard deviation of 10 in the general population. A score of \< 50 on the PCS-12 is a cut-off to determine a physical condition; score of \<42 on the MCS-12 may be indicative of 'clinical depression'. For this study we used change of the SF-12 total score as outcome. Change of SF-12 is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the worse outcome, negative values correspond to the better outcome, i.e. increase of physical and mental health functioning
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT-I + CAU | Short-form Survey (SF-12 Version 1.0) | change pre- to post-treatment | 34.7 units on a scale | Standard Deviation 5.6 |
| iCBT-I + CAU | Short-form Survey (SF-12 Version 1.0) | change from pre-treatment to follow-up | 33.7 units on a scale | Standard Deviation 6.6 |
| Care as usual (CAU) | Short-form Survey (SF-12 Version 1.0) | change pre- to post-treatment | 33.1 units on a scale | Standard Deviation 6.3 |
| Care as usual (CAU) | Short-form Survey (SF-12 Version 1.0) | change from pre-treatment to follow-up | 32.8 units on a scale | Standard Deviation 6.2 |
Secondary
Sleep Efficiency (SE)
Sleep diary derived measure calculated as the ratio of TST to time spent in bed multiplied by 100%, averaged for 1 week pre- post-treatment, post-follow-up. For the purposes of effectiveness investigation change of SOL from pre- to post-treatment and post-follow-up. Change of SE is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the worse outcome, negative values correspond to the better outcome, i.e. increase of sleep efficiency
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT-I + CAU | Sleep Efficiency (SE) | change pre- to post-treatment | 84.5 percent | Standard Deviation 10.4 |
| iCBT-I + CAU | Sleep Efficiency (SE) | change from pre-treatment to follow-up | 83.8 percent | Standard Deviation 8.2 |
| Care as usual (CAU) | Sleep Efficiency (SE) | change pre- to post-treatment | 81.9 percent | Standard Deviation 9.9 |
| Care as usual (CAU) | Sleep Efficiency (SE) | change from pre-treatment to follow-up | 80.2 percent | Standard Deviation 11.9 |
Secondary
Sleep Hygiene Index (SHI)
13-questions questionnaire evaluating each item on a 5-point Likert scale, yielding a total score ranging from 13 to 65. Higher SHI score corresponds to the worse sleep hygiene. Change of SHI is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. worsening of sleep hygiene habits
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT-I + CAU | Sleep Hygiene Index (SHI) | change from pre- to post-treatment | 51.9 units on a scale | Standard Deviation 7.2 |
| iCBT-I + CAU | Sleep Hygiene Index (SHI) | change from pre-treatment to follow-up | 27.7 units on a scale | Standard Deviation 7.7 |
| Care as usual (CAU) | Sleep Hygiene Index (SHI) | change from pre- to post-treatment | 49.8 units on a scale | Standard Deviation 6.5 |
| Care as usual (CAU) | Sleep Hygiene Index (SHI) | change from pre-treatment to follow-up | 28.5 units on a scale | Standard Deviation 6.3 |
Secondary
Sleep Locus of Control Questionnaire (SLC)
variant validated in Russia comprises 8 questions scored using a 6-point Likert scale ranging each answer from 1 = strongly disagree; 6 = strongly agree, yielding a total score ranging from 8 to 48. The Russian adaptation of the scale has shown internal reliability of 0.41. Higher SLC score corresponds to the more marked external locus of control. Change of SLC is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. more prominent external locus of control of sleep
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT-I + CAU | Sleep Locus of Control Questionnaire (SLC) | change from pre- to post-treatment | 38.5 units on a scale | Standard Deviation 9.6 |
| iCBT-I + CAU | Sleep Locus of Control Questionnaire (SLC) | change from pre-treatment to folow-up | 39.8 units on a scale | Standard Deviation 12 |
| Care as usual (CAU) | Sleep Locus of Control Questionnaire (SLC) | change from pre- to post-treatment | 38.6 units on a scale | Standard Deviation 9.9 |
| Care as usual (CAU) | Sleep Locus of Control Questionnaire (SLC) | change from pre-treatment to folow-up | 40.1 units on a scale | Standard Deviation 13.6 |
Secondary
Sleep Onset Latency (SOL),
Sleep diary derived measure averaged for 1 week pre- post-treatment, post-follow-up. For the purposes of effectiveness investigation change of SOL from pre- to post-treatment and post-follow-up. Change of SOL is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of sleep latency
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| iCBT-I + CAU | Sleep Onset Latency (SOL), | change from pre- to post-treatment | 28.2 minutes | Standard Deviation 29 |
| iCBT-I + CAU | Sleep Onset Latency (SOL), | change from pre-treatment to follow-up | 33.3 minutes | Standard Deviation 28.2 |
| Care as usual (CAU) | Sleep Onset Latency (SOL), | change from pre- to post-treatment | 39.2 minutes | Standard Deviation 37.2 |
| Care as usual (CAU) | Sleep Onset Latency (SOL), | change from pre-treatment to follow-up | 42.5 minutes | Standard Deviation 37.1 |
Secondary
Submissiveness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Submissiveness is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Submissiveness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 2.17 units on a scale | Standard Error 0.72 |
| Care as usual (CAU) | Submissiveness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 2.16 units on a scale | Standard Error 0.64 |
Secondary
Success Expectancy
Aims to measure patients' beliefs about the expected treatment success as one of the important outcome predictors. For its evaluation we will use one adapted question of Credibility/Expectancy Questionnaire: At this point, how successfully do you think this treatment will be in reducing your insomnia symptoms? at scale from 1 to 9. This question was chosen as well representing high correlation for both factors: credibility and expectancy, and most logically formulated for the intended purpose
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Success Expectancy | 6.3 score on a scale | Standard Error 1.57 |
| Care as usual (CAU) | Success Expectancy | 6.2 score on a scale | Standard Error 1.64 |
Secondary
Suspiciousness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Suspiciousness is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Suspiciousness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.58 units on a scale | Standard Error 0.56 |
| Care as usual (CAU) | Suspiciousness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.57 units on a scale | Standard Error 0.54 |
Secondary
System Usability Scale (SUS)
10-item non-specific questionnaire used to collect a user's subjective rating of a product's (products, websites, applications, hardware, or software) usability and learnability. Each item is scored on a scale of 0 (strongly Disagree) to 4 (strongly Agree). For positively-worded items (1, 3, 5, 7 and 9), the score contribution is the scale position minus 1. For negatively-worded items (2, 4, 6, 8 and 10), it is 5 minus the scale position. To get the overall SUS score, multiply the sum of the item score contributions by 2.5. Thus, SUS scores range from 0 to 100 in 2.5-point increments. Higher SUS score reflects better subjective usability of the program.
Time frame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
Population: data were not analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | System Usability Scale (SUS) | 32.8 score on a scale | Standard Error 25.1 |
| Care as usual (CAU) | System Usability Scale (SUS) | 10 score on a scale | — |
Secondary
Time Spent on Each Module
measure of adherence. Program-derived outcome
Time frame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
Population: although data were automatically collected by the software, its further analysis was not possible due to the technical problems to extract the data and to use them in the analysis, since it could be done only by a software developer who has left the project earlier. Data are not planned to be analyzed in the future
Secondary
Total Sleep Time (TST)
Sleep diary derived measure averaged for 1 week pre- post-treatment, post-follow-up. For the purposes of effectiveness investigation change of TST from pre- to post-treatment and post-follow-up. Change of TST is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the worse outcome, negative values correspond to the better outcome, i.e. increase of total sleep time
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT-I + CAU | Total Sleep Time (TST) | pre- to post-treatment change | 6.9 hours | Standard Deviation 1.3 |
| iCBT-I + CAU | Total Sleep Time (TST) | change from pre-treatment to follow-up | 7.3 hours | Standard Deviation 1.3 |
| Care as usual (CAU) | Total Sleep Time (TST) | pre- to post-treatment change | 7.0 hours | Standard Deviation 1.2 |
| Care as usual (CAU) | Total Sleep Time (TST) | change from pre-treatment to follow-up | 7.0 hours | Standard Deviation 1.1 |
Secondary
Total Time Spent on the iCBT-I Website
measure of adherence. Program-derived outcome
Time frame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
Population: although data were automatically collected by the software, its further analysis was not possible due to the technical problems to extract the data and to use them in the analysis, since it could be done only by a software developer who has left the project earlier. Data are not planned to be analyzed in the future
Secondary
Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Health Care Consumption
This measure aims to evaluate the cost-effectiveness of iCBT-I. The first part of TIC-P consists of 14 questions on the volume of health care uptake: including the number of medical consultations, dose, and frequency of medication, days of inpatient care. Multiplication of these data by the actual price of medical help produces the cost of medical care as the outcome. The higher outcome represents higher costs of medical care. Change of TiC-P Health care consumption is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. higher costs of the healthcare consumption
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| iCBT-I + CAU | Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Health Care Consumption | Change from pre- to post-treatment | 16500 roubles |
| iCBT-I + CAU | Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Health Care Consumption | Change from pre-treatment to follow-up | 6263 roubles |
| Care as usual (CAU) | Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Health Care Consumption | Change from pre- to post-treatment | 4896 roubles |
| Care as usual (CAU) | Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Health Care Consumption | Change from pre-treatment to follow-up | 5959 roubles |
Secondary
Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Short Form- Health and Labour Questionnaire (SF-HLQ)
This measure aims to evaluate the cost-effectiveness of iCBT-I. The second part of TIC-P is represented by the Short Form- Health and Labour Questionnaire (SF-HLQ), an instrument to collect data on productivity losses (presenteeism and absenteeism) due to health problems. Costs of productivity losses are calculated by multiplication of missed working hours by standard cost price of productivity. The higher outcome represents higher costs of productivity losses. Change of TiC-P productivity losses is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. higher costs of the productivity losses
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| iCBT-I + CAU | Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Short Form- Health and Labour Questionnaire (SF-HLQ) | Change from pre- to post-treatment | 2449 roubles |
| iCBT-I + CAU | Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Short Form- Health and Labour Questionnaire (SF-HLQ) | Change from pre-treatment to follow-up | 1196 roubles |
| Care as usual (CAU) | Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Short Form- Health and Labour Questionnaire (SF-HLQ) | Change from pre- to post-treatment | 7238 roubles |
| Care as usual (CAU) | Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Short Form- Health and Labour Questionnaire (SF-HLQ) | Change from pre-treatment to follow-up | 2853 roubles |
Secondary
Unusual Beliefs Experience From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Unusual beliefs experience is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Unusual Beliefs Experience From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.24 units on a scale | Standard Error 0.36 |
| Care as usual (CAU) | Unusual Beliefs Experience From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.13 units on a scale | Standard Error 0.22 |
Secondary
Usage of the Support
number of referrals to the supporting psychologist through the feedback form. Program-derived outcome
Time frame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Usage of the Support | 9.44 number of emails to the support | Standard Error 4.14 |
| Care as usual (CAU) | Usage of the Support | 7.74 number of emails to the support | Standard Error 4.03 |
Secondary
User Satisfaction
feedback questionnaire developed for this study. It includes 1 question about satisfaction or dissatisfaction with the treatment with a 5-point Likert scale, from 1 (very poor/not at all useful) to 5 (very, good/very useful). The questionnaire also contains open questions aiming for utilitarian goals, i.e. to improve the program (possible negative effects of the intervention if any: deterioration of insomnia symptoms, adverse effects, novel symptoms; and about improvement suggestions, what participants liked most if they would recommend it to a friend with insomnia). These questions are not included in questionnaire score
Time frame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | User Satisfaction | 3.7 score on a scale | Standard Error 1.28 |
| Care as usual (CAU) | User Satisfaction | 5.0 score on a scale | — |
Secondary
Wake After Sleep Onset (WASO)
Sleep diary derived measure averaged for 1 week pre- post-treatment, post-follow-up. For the purposes of effectiveness investigation change of WASO from pre- to post-treatment and post-follow-up. Change of WASO is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of the time spent awake after sleep onset
Time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT-I + CAU | Wake After Sleep Onset (WASO) | change pre- to post-treatment | 19.0 minutes | Standard Deviation 16.7 |
| iCBT-I + CAU | Wake After Sleep Onset (WASO) | change pre-treatment to follow-up | 28.8 minutes | Standard Deviation 22 |
| Care as usual (CAU) | Wake After Sleep Onset (WASO) | change pre- to post-treatment | 28.0 minutes | Standard Deviation 35.2 |
| Care as usual (CAU) | Wake After Sleep Onset (WASO) | change pre-treatment to follow-up | 29.3 minutes | Standard Deviation 29.3 |
Secondary
Withdrawal From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement
100-item self-report inventory designed to assess the 25 pathological personality trait facets and the 5 domains based on the dimensional trait model (DSM-5 Section III). Withdrawal is one of the personality trait facets and its total score is a sum of 4 items which are rated on a 4-point Likert scale from 0 (very false or often false) to 3 (very true or often true). Therefore the total score may vary from 0 to 12, where higher value represent the higher expression of this pathological facet
Time frame: Once at baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iCBT-I + CAU | Withdrawal From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 1.81 units on a scale | Standard Error 0.68 |
| Care as usual (CAU) | Withdrawal From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement | 2.08 units on a scale | Standard Error 0.65 |