Sleep Problem
Conditions
Brief summary
Insomnia occurs frequently causing a substantial burden to society (1). Historically, insomnia has been considered as secondary to a handful of other psychiatric disorders, such as depression and anxiety - but it is now clear that this disorder is associated with a wide range of psychiatric conditions and may actually precede and predict their development and severity (e.g. 2). Treating insomnia has been posited to hold the promise of reducing or preventing the development of co-morbid problems - although this possibility needs to be rigorously tested. Cognitive behavioural therapy (CBT) is an effective treatment for disturbed sleep, specifically insomnia, in adults (3) and is recommended by NICE for the management of long-term sleep problems. This treatment is more accessible than ever before given recent ground-breaking internet initiatives - such as the Sleepio programme (see: https://www.sleepio.com/home/), which was developed by one of the collaborators (Colin Espie) and has yielded encouraging results (4). Despite the importance of CBT for treating disturbed sleep and the finding that it leads to a good outcome for the majority of sufferers, some people fail to respond to this treatment. For example, research cited on the Sleepio website notes that around 70% of those with even very long term sleep difficulties experience long-term improvements from the treatment, meaning that 30% do not (see 4). Understanding more about who does and does not respond holds the promise of improving or tailoring treatments for insomnia. The study proposed here builds on recent work by one of the researchers who has been exploring demographic (5), clinical (e.g. 6) and most uniquely genetic (e.g. 7); and epigenetic (e.g. 8) predictors of psychological treatment response (coining the term Therapygenetics, see, 7). While these predictors are individually only likely to explain a small proportion of the variance of treatment outcome, understanding these multiple risks and their interaction is the best way to consider this issue. The study addressed here is a pilot study, necessary to demonstrate feasibility of utilising a sleep intervention application in an unselected sample of young adults, prior to applying for grant funding to undertake a larger but similar behavioural genetics study in the future. The main aim of this pilot study is to test the feasibility of the study design, by investigating whether unselected participants show an improvement in sleep quality after taking the intervention. Participation and drop out rates as well acceptability of the intervention in a non-clinical population will also be investigated. Research Questions: 1. Does the online CBT intervention improve sleep quality in a non-clinical, unselected sample? 2. How feasible is it to run this study on a non-clinical sample? This will include investigating response rate, participant drop-out, and treatment accessibility. The investigators will also offer perform preliminary investigations into: 3. Does improving sleep quality have implications for associated phenotypes? Specifically the investigators will examine symptoms of anxiety, depression, attention-deficit hyperactivity disorder (ADHD), psychosis, and well-being. 4. Which demographic, clinical, genetic, and epigenetic factors predict treatment outcome for sleep problems? Research questions 3) and 4) will be primary aims in the main study, but will constitute secondary aims in the pilot study as there won't be the statistical power to fully address these questions.
Interventions
PROCEDUREOnline CBT for insomnia
See CBT arm description for information about the CBT intervention. More details can be found in source 4 in the reference list.
Sponsors
Goldsmiths, University of London
Queen Mary University of London
University of Oxford
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion * Female * Aged 18 plus * Psychology student (undergraduate or postgraduate) at one of three London universities involved in the study. Exclusion * Male * Under 18 * Not a psychology student (undergraduate or postgraduate) at one of three London universities involved in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attrition Rate | 6 months | Drop-out rate will be assessed as the percentage of those who consented to take part in the study who did not complete the study. |
| Change in Treatment Acceptability During the Intervention | Change from baseline to 3 weeks and 6 weeks | Change in treatment acceptability across the CBT-I treatment will be assessed, through changes in the score on the Treatment Acceptability Scale. Acceptability of the CBT-I in an unselected sample will be assessed, and measured using an adapted version of the Treatment Acceptability Questionnaire (TAQ) suitable for use with an online therapist. The TAQ has a theoretical range of 6-42, with a higher score indicating higher levels of treatment acceptability. Therefore a positive change score means an improvement in treatment acceptability, whereas a negative change score indicates a reduction in treatment acceptability. |
| Improvement in Insomnia Symptoms Following Online CBT | Change from baseline to 3 weeks, 6 weeks, and 6 months | Changes in insomnia symptoms as assessed by scores on the Sleep Condition Indicator (SCI). This pilot aims to establish the distributional properties of individual differences in change score on this measure. The scale has a theoretical range of 0-32. A higher score indicates fewer insomnia symptoms. Therefore a positive change score (\>0) indicates fewer insomnia symptoms at the end of the intervention compared to baseline. A negative score (\<0) indicates more symptoms at the end of the itnervention compared to baseline. |
| Improvement in Sleep Quality Following Online CBT | Change from baseline to 3 weeks, 6 weeks, and 6 months | Changes in sleep quality as assessed by scores on the Pittsburgh Sleep Quality Index (PSQI). This pilot aims to establish the distributional properties of individual differences in change score on this measure. The scale has a theoretical range of 0-21. The change score reflects the change in symptoms at each assessment compared with baseline. Higher scores on the indicate worse sleep quality. Therefore for the change score, a positive value indicates worse sleep quality at the assessment time period compared to baseline. A negative value indicates better sleep quality at the assessment time period compared to baseline. |
| Treatment Acceptability Mid-intervention | 3 weeks | Acceptability of the CBT-I in an unselected sample will be assessed, and measured using an adapted version of the Treatment Acceptability Questionnaire (TAQ) suitable for use with an online therapist. The TAQ has a theoretical range of 6-42, with a higher score indicating higher levels of treatment acceptability. |
| Treatment Acceptability at the End of the Intervention | 6 weeks | Acceptability of the CBT-I in an unselected sample will be assessed, and measured using an adapted version of the Treatment Acceptability Questionnaire (TAQ) suitable for use with an online therapist. The TAQ has a theoretical range of 6-42, with a higher score indicating higher levels of treatment acceptability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predictors of Treatment Outcome - Threatening Life Events | Baseline | Threatening life events as a predictor of response to treatment outcome, as measured using the List of Threatening Events. The theoretical range is 0-24, and a higher score indicates more exposure to threatening events in the 12 months preceeding baseline |
| Changes in Scores on Associated Phenotypes - Anxiety | 3 weeks, 6 weeks | Anxiety symptoms, measured using the State Trait Anxiety Index. The theoretical range is 20-80, and a higher score indicates more anxiety symptoms at baseline. |
| Changes in Scores on Associated Phenotypes - Depression | 3 weeks, 6 weeks | Depression symptoms, as measured using the Trait State Anxiety Index. The theoretical range is 0-26, and a higher score indicates more depression symptoms. |
| Changes in Scores on Associated Phenotypes - Stress | 3 weeks, 6 weeks | Perceived stress, as measured using the Perceived Stress Scale. The theoretical range is 5-50, and a higher score indicates higher levels of perceived stress. |
| Predictors of Treatment Outcome - Anxiety | Baseline | Anxiety as a predictor of response to treatment outcome, as measured using the Trait State Anxiety Index. The theoretical range is 20-80, and a higher score indicates more anxiety symptoms at baseline |
| Changes in Scores on Associated Phenotypes - Psychotic Experiences | 6 weeks | Psychotic experiences, as measured using the Specific Psychotic Experiences Questionnaire. Three subscales measuring paranoia (theoretical ragne 0-25), hallucinations (0-25), and cognitive disorganization (0-5) were used. On all subscales, a higher score equals more frequent experiences |
| Changes in Scores on Associated Phenotypes - Positive Mental Health | 3 weeks, 6 weeks | Positive mental health, as measured using the Positive Mental Health Scale. The theoretical range is 1-36, and a higher score indicates higher levels of positive mental health. |
| Changes in Scores on Associated Phenotypes - Attentional Problems | 3 weeks, 6 weeks | Attentional problems, as measured using the ADHD symptoms questionnaire. The theoretical range is 1-54, and a higher score indicates more attentional problems. |
| Predictors of Treatment Outcome - Depression | Baseline | Anxiety as a predictor of response to treatment outcome, as measured using the Mood and Feelings Questionnaire. The theoretical range is 0-26, and a higher score indicates more anxiety symptoms at baseline |
| Predictors of Treatment Outcome - Attentional Problems | Baseline | Attentional problems as a predictor of response to treatment outcome, as measured using the ADHD symptoms questionnaire. The theoretical range is 1-54, and a higher score indicates more attentional problems at baseline |
| Predictors of Treatment Outcome - Psychotic Experiences | Baseline | Psychotic experiences as a predictor of response to treatment outcome, as measured using the Specific Psychotic Experiences Questionnaire. Subsacles measuring paranoia (theoretical range 0-25), hallucinations (theoretical range 0-25), and cognitive disorganization (0-5) were used. On all subscales, a higher score indicates more psychotic experiences at baseline |
| Predictors of Treatment Outcome - Positive Mental Health | Baseline | Positive mental health as a predictor of response to treatment outcome, as measured using the Positive Mental Health Scale. The theoretical range is 1-36, and a higher score indicates higher levels of positive mental health at baseline |
| Predictors of Treatment Outcome - Stress | Baseline | Stress as a predictor of response to treatment outcome, as measured using the Perceived Stress Scale. The theoretical range is 5-50, and a higher score indicates more perceived stress at baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Phenotypic Associations With Exploding Head Syndrome | Baseline | Exploding head syndrome is an unusual and understudied phenomenon associated with sleep. Measures included in this study shall be used in an exploratory fashion to perform a cross-sectional analysis looking at associations between exploding head syndrome and factors such as sleep problems, depression, anxiety, and well-being. Exploding head syndrome was measured using a 1-5 scale, where 1 = never experienced and 5 = several times a week. Sleep paralysis was measured using a 1-7 scale ranging from 1 = never observed to 7 = several times a week. |
| Online CBT for Insomnia in Sleep Paralysis | Change from baseline to 6 weeks | Sleep paralysis is a relatively common but understudied phenomenon that has the potential to cause large amounts of fear and/or distress in individuals who experience it. As an exploratory analysis, it shall be investigated whether individuals assigned to the CBT intervention who also experience sleep paralysis show any reductions in the frequency of episodes, and associate levels of fear/distress throughout the programme. As this isn't a main aim of the study, this aim is dependent upon a sufficient number of participants who experience sleep paralysis being present in the sample. It is unlikely that there will be sufficient power to thoroughly assess this, but it is hoped this will provide helpful information to future studies. |
Countries
United Kingdom
Participant flow
Pre-assignment details
A total of 240 participants gave informed consent. After consent, participants were required to complete the baseline assessments before being assigned to a group. A total of 41 participants did not fill out this survey despite consenting, meaning a total of 199 participants were assigned to a group.
Participants by arm
| Arm | Count |
|---|---|
| Online CBT for Insomnia CBT participants will receive six weekly sessions delivered by an animated 'virtual therapist' (The Prof) via the online platform 'Sleepio'. The programme comprises a fully automated media-rich web application, driven dynamically by baseline, adherence, performance and progress data, and provides additional access to elements such as an online library with background information, a community of fellow users, and support, prompts and reminders sent by e-mail.
CBT content was consistent with the literature (4) and covered behavioral (e.g., sleep restriction, stimulus control) and cognitive (e.g., putting the day to rest, thought restructuring, imagery, articulatory suppression, paradoxical intention, mindfulness) strategies, as well as additional relaxation strategies (progressive muscle relaxation and autogenic training) and advice on lifestyle and bedroom factors (sleep hygiene). The intervention was based upon a previously validated manual (4). | 99 |
| Puzzles Each week participants will be sent a puzzle to complete online (e.g. logic puzzles, crosswords etc). The puzzles have been designed to be cognitively engaging and take a similar amount of time to one session of Sleepio (20-25 minutes). | 100 |
| Total | 199 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 50 | 38 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Online CBT for Insomnia | Puzzles | Total |
|---|---|---|---|
| Age, Continuous | 19.73 years STANDARD_DEVIATION 2.94 | 20.22 years STANDARD_DEVIATION 5.69 | 20.22 years STANDARD_DEVIATION 4.78 |
| Insomnia symptoms | 19.70 units on a scale STANDARD_DEVIATION 6.56 | 20.22 units on a scale STANDARD_DEVIATION 6.53 | 19.97 units on a scale STANDARD_DEVIATION 6.53 |
| Race/Ethnicity, Customized Arab | 4 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian or Asian British | 10 Participants | 20 Participants | 30 Participants |
| Race/Ethnicity, Customized Black or Black Britsh | 6 Participants | 5 Participants | 11 Participants |
| Race/Ethnicity, Customized Mixed ethnicity | 6 Participants | 8 Participants | 14 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 5 Participants | 10 Participants |
| Race/Ethnicity, Customized Prefer not to say | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Selected more than one ethnicity | 25 Participants | 19 Participants | 44 Participants |
| Race/Ethnicity, Customized White | 43 Participants | 41 Participants | 84 Participants |
| Region of Enrollment United Kingdom | 99 Participants | 100 Participants | 199 Participants |
| Sex: Female, Male Female | 99 Participants | 100 Participants | 199 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 100 |
| other Total, other adverse events | 0 / 99 | 0 / 100 |
| serious Total, serious adverse events | 0 / 99 | 0 / 100 |
Outcome results
Primary
Attrition Rate
Drop-out rate will be assessed as the percentage of those who consented to take part in the study who did not complete the study.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Online CBT for Insomnia | Attrition Rate | 47 percentage of participants |
| Puzzles | Attrition Rate | 62 percentage of participants |
Primary
Change in Treatment Acceptability During the Intervention
Change in treatment acceptability across the CBT-I treatment will be assessed, through changes in the score on the Treatment Acceptability Scale. Acceptability of the CBT-I in an unselected sample will be assessed, and measured using an adapted version of the Treatment Acceptability Questionnaire (TAQ) suitable for use with an online therapist. The TAQ has a theoretical range of 6-42, with a higher score indicating higher levels of treatment acceptability. Therefore a positive change score means an improvement in treatment acceptability, whereas a negative change score indicates a reduction in treatment acceptability.
Time frame: Change from baseline to 3 weeks and 6 weeks
Population: Treatment acceptability was only assessed in the Online CBT for insomnia group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online CBT for Insomnia | Change in Treatment Acceptability During the Intervention | 3.65 score on a scale | Standard Deviation 3.98 |
Primary
Improvement in Insomnia Symptoms Following Online CBT
Changes in insomnia symptoms as assessed by scores on the Sleep Condition Indicator (SCI). This pilot aims to establish the distributional properties of individual differences in change score on this measure. The scale has a theoretical range of 0-32. A higher score indicates fewer insomnia symptoms. Therefore a positive change score (\>0) indicates fewer insomnia symptoms at the end of the intervention compared to baseline. A negative score (\<0) indicates more symptoms at the end of the itnervention compared to baseline.
Time frame: Change from baseline to 3 weeks, 6 weeks, and 6 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Online CBT for Insomnia | Improvement in Insomnia Symptoms Following Online CBT | 6 weeks | 4.69 score on a scale |
| Online CBT for Insomnia | Improvement in Insomnia Symptoms Following Online CBT | 3 weeks | 2.98 score on a scale |
| Online CBT for Insomnia | Improvement in Insomnia Symptoms Following Online CBT | 6 months | 4.89 score on a scale |
| Puzzles | Improvement in Insomnia Symptoms Following Online CBT | 3 weeks | 1.26 score on a scale |
| Puzzles | Improvement in Insomnia Symptoms Following Online CBT | 6 weeks | 2.34 score on a scale |
| Puzzles | Improvement in Insomnia Symptoms Following Online CBT | 6 months | 2.05 score on a scale |
Primary
Improvement in Sleep Quality Following Online CBT
Changes in sleep quality as assessed by scores on the Pittsburgh Sleep Quality Index (PSQI). This pilot aims to establish the distributional properties of individual differences in change score on this measure. The scale has a theoretical range of 0-21. The change score reflects the change in symptoms at each assessment compared with baseline. Higher scores on the indicate worse sleep quality. Therefore for the change score, a positive value indicates worse sleep quality at the assessment time period compared to baseline. A negative value indicates better sleep quality at the assessment time period compared to baseline.
Time frame: Change from baseline to 3 weeks, 6 weeks, and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online CBT for Insomnia | Improvement in Sleep Quality Following Online CBT | 3 weeks | -0.71 score on a scale | Standard Deviation 3.32 |
| Online CBT for Insomnia | Improvement in Sleep Quality Following Online CBT | 6 weeks | -1.92 score on a scale | Standard Deviation 3.35 |
| Online CBT for Insomnia | Improvement in Sleep Quality Following Online CBT | 6 months | 0 score on a scale | Standard Deviation 4.41 |
| Puzzles | Improvement in Sleep Quality Following Online CBT | 3 weeks | -0.47 score on a scale | Standard Deviation 3.47 |
| Puzzles | Improvement in Sleep Quality Following Online CBT | 6 weeks | -1.11 score on a scale | Standard Deviation 2.94 |
| Puzzles | Improvement in Sleep Quality Following Online CBT | 6 months | -1.56 score on a scale | Standard Deviation 3.53 |
Primary
Treatment Acceptability at the End of the Intervention
Acceptability of the CBT-I in an unselected sample will be assessed, and measured using an adapted version of the Treatment Acceptability Questionnaire (TAQ) suitable for use with an online therapist. The TAQ has a theoretical range of 6-42, with a higher score indicating higher levels of treatment acceptability.
Time frame: 6 weeks
Population: Treatment acceptability was only measured in the Online CBT for insomnia group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online CBT for Insomnia | Treatment Acceptability at the End of the Intervention | 33.61 score on a scale | Standard Deviation 4.82 |
Primary
Treatment Acceptability Mid-intervention
Acceptability of the CBT-I in an unselected sample will be assessed, and measured using an adapted version of the Treatment Acceptability Questionnaire (TAQ) suitable for use with an online therapist. The TAQ has a theoretical range of 6-42, with a higher score indicating higher levels of treatment acceptability.
Time frame: 3 weeks
Population: Treatment acceptability was only measured in the Online CBT for insomnia group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online CBT for Insomnia | Treatment Acceptability Mid-intervention | 29.96 score on a scale | Standard Deviation 3.79 |
Secondary
Changes in Scores on Associated Phenotypes - Anxiety
Anxiety symptoms, measured using the State Trait Anxiety Index. The theoretical range is 20-80, and a higher score indicates more anxiety symptoms at baseline.
Time frame: 3 weeks, 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online CBT for Insomnia | Changes in Scores on Associated Phenotypes - Anxiety | Mid intervention | 46.68 score on a scale | Standard Deviation 11.86 |
| Online CBT for Insomnia | Changes in Scores on Associated Phenotypes - Anxiety | End of intervention | 44.57 score on a scale | Standard Deviation 11.2 |
| Puzzles | Changes in Scores on Associated Phenotypes - Anxiety | Mid intervention | 46.58 score on a scale | Standard Deviation 10.26 |
| Puzzles | Changes in Scores on Associated Phenotypes - Anxiety | End of intervention | 45.32 score on a scale | Standard Deviation 10.07 |
Comparison: This analysis looked at the effect of group on changes in anxiety symptoms across the intervention period.p-value: 0.0395% CI: [-4.9, -0.25]Generalized estimating equation
Secondary
Changes in Scores on Associated Phenotypes - Attentional Problems
Attentional problems, as measured using the ADHD symptoms questionnaire. The theoretical range is 1-54, and a higher score indicates more attentional problems.
Time frame: 3 weeks, 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online CBT for Insomnia | Changes in Scores on Associated Phenotypes - Attentional Problems | 16.51 score on a scale | Standard Deviation 10.53 |
| Puzzles | Changes in Scores on Associated Phenotypes - Attentional Problems | 18.53 score on a scale | Standard Deviation 13.33 |
Comparison: This analysis looked at the effect of group on changes attentional problems across the intervention period.p-value: 0.1195% CI: [-5.21, 0.53]Generalized estimating equation
Secondary
Changes in Scores on Associated Phenotypes - Depression
Depression symptoms, as measured using the Trait State Anxiety Index. The theoretical range is 0-26, and a higher score indicates more depression symptoms.
Time frame: 3 weeks, 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online CBT for Insomnia | Changes in Scores on Associated Phenotypes - Depression | Mid intervention | 8.70 score on a scale | Standard Deviation 7.2 |
| Online CBT for Insomnia | Changes in Scores on Associated Phenotypes - Depression | End of intervention | 6.91 score on a scale | Standard Deviation 5.73 |
| Puzzles | Changes in Scores on Associated Phenotypes - Depression | Mid intervention | 8.00 score on a scale | Standard Deviation 7.01 |
| Puzzles | Changes in Scores on Associated Phenotypes - Depression | End of intervention | 6.51 score on a scale | Standard Deviation 5.87 |
Comparison: This analysis looked at the effect of group on changes in depression symptoms across the intervention period.p-value: 0.45695% CI: [-2.24, 1.01]Generalized estimating equation
Secondary
Changes in Scores on Associated Phenotypes - Positive Mental Health
Positive mental health, as measured using the Positive Mental Health Scale. The theoretical range is 1-36, and a higher score indicates higher levels of positive mental health.
Time frame: 3 weeks, 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online CBT for Insomnia | Changes in Scores on Associated Phenotypes - Positive Mental Health | Mid intervention | 25.39 score on a scale | Standard Deviation 7.01 |
| Online CBT for Insomnia | Changes in Scores on Associated Phenotypes - Positive Mental Health | End of intervention | 26.42 score on a scale | Standard Deviation 6.18 |
| Puzzles | Changes in Scores on Associated Phenotypes - Positive Mental Health | Mid intervention | 26.46 score on a scale | Standard Deviation 5.69 |
| Puzzles | Changes in Scores on Associated Phenotypes - Positive Mental Health | End of intervention | 27.09 score on a scale | Standard Deviation 6.09 |
Comparison: This analysis looked at the effect of group on changes in positive mental health across the intervention period.p-value: 0.91695% CI: [-1.17, 1.3]Generalized estimating equation
Secondary
Changes in Scores on Associated Phenotypes - Psychotic Experiences
Psychotic experiences, as measured using the Specific Psychotic Experiences Questionnaire. Three subscales measuring paranoia (theoretical ragne 0-25), hallucinations (0-25), and cognitive disorganization (0-5) were used. On all subscales, a higher score equals more frequent experiences
Time frame: 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online CBT for Insomnia | Changes in Scores on Associated Phenotypes - Psychotic Experiences | Paranoia | 4.59 score on a scale | Standard Deviation 5.77 |
| Online CBT for Insomnia | Changes in Scores on Associated Phenotypes - Psychotic Experiences | Hallucinations | 1.59 score on a scale | Standard Deviation 3.24 |
| Online CBT for Insomnia | Changes in Scores on Associated Phenotypes - Psychotic Experiences | Cognitive disorganization | 2.65 score on a scale | Standard Deviation 1.89 |
| Puzzles | Changes in Scores on Associated Phenotypes - Psychotic Experiences | Paranoia | 6.07 score on a scale | Standard Deviation 5.92 |
| Puzzles | Changes in Scores on Associated Phenotypes - Psychotic Experiences | Hallucinations | 1.31 score on a scale | Standard Deviation 2.42 |
| Puzzles | Changes in Scores on Associated Phenotypes - Psychotic Experiences | Cognitive disorganization | 3.07 score on a scale | Standard Deviation 1.52 |
Comparison: This analysis looked at the effect of group on changes in psychotic experiences (paranoia) across the intervention period.p-value: 0.04195% CI: [-3.31, -0.07]Generalized estimating equations
Comparison: This analysis looked at the effect of group on changes in psychotic experiences (hallucinations) across the intervention period.p-value: 0.53195% CI: [-0.92, 0.48]Generalized estimating equation
Comparison: This analysis looked at the effect of group on changes in psychotic experiences (cognitive disorganization) across the intervention period.p-value: 0.1395% CI: [-0.84, 0.11]Generalized estimating equation
Secondary
Changes in Scores on Associated Phenotypes - Stress
Perceived stress, as measured using the Perceived Stress Scale. The theoretical range is 5-50, and a higher score indicates higher levels of perceived stress.
Time frame: 3 weeks, 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online CBT for Insomnia | Changes in Scores on Associated Phenotypes - Stress | Mid intervention | 17.92 score on a scale | Standard Deviation 8.24 |
| Online CBT for Insomnia | Changes in Scores on Associated Phenotypes - Stress | End of intervention | 16.96 score on a scale | Standard Deviation 6.57 |
| Puzzles | Changes in Scores on Associated Phenotypes - Stress | Mid intervention | 19.14 score on a scale | Standard Deviation 7.56 |
| Puzzles | Changes in Scores on Associated Phenotypes - Stress | End of intervention | 17.71 score on a scale | Standard Deviation 8.06 |
Comparison: This analysis looked at the effect of group on changes in perceived stress across the intervention period.p-value: 0.02795% CI: [-3.83, -0.23]Generalized estimating equation
Secondary
Predictors of Treatment Outcome - Anxiety
Anxiety as a predictor of response to treatment outcome, as measured using the Trait State Anxiety Index. The theoretical range is 20-80, and a higher score indicates more anxiety symptoms at baseline
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online CBT for Insomnia | Predictors of Treatment Outcome - Anxiety | 49.93 score on a scale | Standard Deviation 10.64 |
| Puzzles | Predictors of Treatment Outcome - Anxiety | 47.53 score on a scale | Standard Deviation 9.92 |
Comparison: This analysis looked at the interaction between baseline anxiety symptoms and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.p-value: 0.57295% CI: [-1.33, 2.4]Regression, Linear
Secondary
Predictors of Treatment Outcome - Attentional Problems
Attentional problems as a predictor of response to treatment outcome, as measured using the ADHD symptoms questionnaire. The theoretical range is 1-54, and a higher score indicates more attentional problems at baseline
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online CBT for Insomnia | Predictors of Treatment Outcome - Attentional Problems | 21.47 score on a scale | Standard Deviation 11.69 |
| Puzzles | Predictors of Treatment Outcome - Attentional Problems | 22.09 score on a scale | Standard Deviation 11.62 |
Comparison: This analysis looked at the interaction between attentional problems and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.p-value: 0.25395% CI: [-0.76, 2.89]Regression, Linear
Secondary
Predictors of Treatment Outcome - Depression
Anxiety as a predictor of response to treatment outcome, as measured using the Mood and Feelings Questionnaire. The theoretical range is 0-26, and a higher score indicates more anxiety symptoms at baseline
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online CBT for Insomnia | Predictors of Treatment Outcome - Depression | 10.09 score on a scale | Standard Deviation 6.71 |
| Puzzles | Predictors of Treatment Outcome - Depression | 8.65 score on a scale | Standard Deviation 6.27 |
Comparison: This analysis looked at the interaction between baseline depression symptoms and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.p-value: 0.93495% CI: [-1.82, 1.98]Regression, Linear
Secondary
Predictors of Treatment Outcome - Positive Mental Health
Positive mental health as a predictor of response to treatment outcome, as measured using the Positive Mental Health Scale. The theoretical range is 1-36, and a higher score indicates higher levels of positive mental health at baseline
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online CBT for Insomnia | Predictors of Treatment Outcome - Positive Mental Health | 26.00 score on a scale | Standard Deviation 6.44 |
| Puzzles | Predictors of Treatment Outcome - Positive Mental Health | 26.64 score on a scale | Standard Deviation 5.76 |
Comparison: This analysis looked at the interaction between baseline positive mental health and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.p-value: 0.895% CI: [-2.16, 1.67]Regression, Linear
Secondary
Predictors of Treatment Outcome - Psychotic Experiences
Psychotic experiences as a predictor of response to treatment outcome, as measured using the Specific Psychotic Experiences Questionnaire. Subsacles measuring paranoia (theoretical range 0-25), hallucinations (theoretical range 0-25), and cognitive disorganization (0-5) were used. On all subscales, a higher score indicates more psychotic experiences at baseline
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online CBT for Insomnia | Predictors of Treatment Outcome - Psychotic Experiences | Paranoia | 6.66 score on a scale | Standard Deviation 5.76 |
| Online CBT for Insomnia | Predictors of Treatment Outcome - Psychotic Experiences | Hallucinations | 3.03 score on a scale | Standard Deviation 3.71 |
| Online CBT for Insomnia | Predictors of Treatment Outcome - Psychotic Experiences | Cognitive disorganization | 3.19 score on a scale | Standard Deviation 1.55 |
| Puzzles | Predictors of Treatment Outcome - Psychotic Experiences | Paranoia | 6.43 score on a scale | Standard Deviation 5.2 |
| Puzzles | Predictors of Treatment Outcome - Psychotic Experiences | Hallucinations | 2.02 score on a scale | Standard Deviation 2.55 |
| Puzzles | Predictors of Treatment Outcome - Psychotic Experiences | Cognitive disorganization | 3.33 score on a scale | Standard Deviation 1.55 |
Comparison: This analysis looked at the interaction between baseline paranois and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.p-value: 0.21595% CI: [-0.7, 3.1]Regression, Linear
Comparison: This analysis looked at the interaction between baseline hallucinations and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.p-value: 0.25495% CI: [-0.83, 3.11]Regression, Linear
Comparison: This analysis looked at the interaction between baseline cognitive disorganization and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.p-value: 0.77895% CI: [-2.13, 1.59]Regression, Linear
Secondary
Predictors of Treatment Outcome - Stress
Stress as a predictor of response to treatment outcome, as measured using the Perceived Stress Scale. The theoretical range is 5-50, and a higher score indicates more perceived stress at baseline
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online CBT for Insomnia | Predictors of Treatment Outcome - Stress | 20.14 score on a scale | Standard Deviation 6.82 |
| Puzzles | Predictors of Treatment Outcome - Stress | 20.05 score on a scale | Standard Deviation 6.12 |
Comparison: This analysis looked at the interaction between baseline perceived stress and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.p-value: 0.52595% CI: [-1.25, 2.44]Regression, Linear
Secondary
Predictors of Treatment Outcome - Threatening Life Events
Threatening life events as a predictor of response to treatment outcome, as measured using the List of Threatening Events. The theoretical range is 0-24, and a higher score indicates more exposure to threatening events in the 12 months preceeding baseline
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online CBT for Insomnia | Predictors of Treatment Outcome - Threatening Life Events | 2.57 score on a scale | Standard Deviation 2.31 |
| Puzzles | Predictors of Treatment Outcome - Threatening Life Events | 2.72 score on a scale | Standard Deviation 2.69 |
Comparison: This analysis looked at the interaction between baseline threatening life events and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.p-value: 0.1495% CI: [-0.43, 3.03]Regression, Linear
Other Pre-specified
Online CBT for Insomnia in Sleep Paralysis
Sleep paralysis is a relatively common but understudied phenomenon that has the potential to cause large amounts of fear and/or distress in individuals who experience it. As an exploratory analysis, it shall be investigated whether individuals assigned to the CBT intervention who also experience sleep paralysis show any reductions in the frequency of episodes, and associate levels of fear/distress throughout the programme. As this isn't a main aim of the study, this aim is dependent upon a sufficient number of participants who experience sleep paralysis being present in the sample. It is unlikely that there will be sufficient power to thoroughly assess this, but it is hoped this will provide helpful information to future studies.
Time frame: Change from baseline to 6 weeks
Other Pre-specified
Phenotypic Associations With Exploding Head Syndrome
Exploding head syndrome is an unusual and understudied phenomenon associated with sleep. Measures included in this study shall be used in an exploratory fashion to perform a cross-sectional analysis looking at associations between exploding head syndrome and factors such as sleep problems, depression, anxiety, and well-being. Exploding head syndrome was measured using a 1-5 scale, where 1 = never experienced and 5 = several times a week. Sleep paralysis was measured using a 1-7 scale ranging from 1 = never observed to 7 = several times a week.
Time frame: Baseline
Population: This aim was only focused on the baseline data. Therefore, all participants are included in this analysis independent of which group they were assigned to. As such, results of all participants combined are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online CBT for Insomnia | Phenotypic Associations With Exploding Head Syndrome | Exploding head syndrome | 1.64 score on a scale | Standard Deviation 0.98 |
| Online CBT for Insomnia | Phenotypic Associations With Exploding Head Syndrome | Sleep paralysis | 1.98 score on a scale | Standard Deviation 1.35 |
Comparison: Assocation between baseline anxiety symptoms and exploding head syndromep-value: 0.29695% CI: [0.77, 2.4]Regression, Logistic
Comparison: Assocation between baseline insomnia symptoms and exploding head syndromep-value: 0.06595% CI: [0.47, 1.02]Regression, Logistic
Comparison: Assocation between baseline depression symptoms and exploding head syndromep-value: 0.14595% CI: [0.39, 1.15]Regression, Logistic
Comparison: Assocation between baseline life stress and exploding head syndromep-value: 0.39895% CI: [0.73, 2.19]Regression, Logistic
Comparison: Assocation between sleep paralysis and exploding head syndromep-value: 0.00195% CI: [1.24, 2.38]Regression, Logistic