Mental Disorders
Conditions
Brief summary
Mental illness is often severe, chronic and difficult to treat. The sleep disturbance commonly experienced by individuals with a severe mental illness reduces capacity to function and contributes to key symptoms. This study seeks to determine if an intervention to improve sleep can improve functioning and reduce symptoms and impairment. The investigators will conduct this study in community mental health centers to ensure that the results contribute to closing the worrisome gap between research and practice and to ensure that the findings are generalizable to the real world.
Detailed description
Despite advances in treatment, severe mental illness (SMI) remains common, chronic and difficult to treat. SMI is defined as having at least one mental disorder that lasts for 12-months and leads to substantial life interference. Sleep and circadian dysfunctions are among the most prominent correlates of SMI, yet have been minimally studied in ways that reflect the complexity of the sleep problems experienced by people with SMI. In SMI, sleep and circadian dysfunction undermines affect regulation, cognitive function and physical health, predicts onset and worsening of symptoms and is often chronic even with evidence-based SMI treatment. Prior treatment studies have been disorder-focused-they have treated a specific sleep problem (e.g., insomnia) in a specific diagnostic group (e.g., depression). However, real life sleep and circadian problems are not so neatly categorized, particularly in SMI where features of insomnia overlap with hypersomnia, delayed sleep phase and irregular sleep-wake schedules. Accordingly, the investigators aim to test the hypothesis that a Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) will improve functional impairment, disorder-focused symptoms and sleep and circadian functioning. The investigators will recruit participants across Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnoses and across common sleep and circadian problems. The elements of TranS-C are efficacious across SMI in research settings with research-based providers. The next step is to test TranS-C in community settings with community-based providers. Accordingly, the investigators propose to conduct an 'efficacy in the real world' randomized controlled trial within Alameda County Behavioral Health Care Services (ACBHCS), the community mental health center (CMHC) for Alameda County. The investigators will recruit 120 adults diagnosed with SMI and sleep and circadian dysfunction within ACBHCS. Individuals will be randomly allocated to TranS-C (n = 60) or 6-months of Usual Care followed by Delayed Treatment with TranS-C (UC-DT; n = 60). TranS-C is modularized and delivered across eight to twelve 50-minute, weekly, individual sessions. All participants will be assessed before, immediately following treatment (ie. 9-14 weeks later) and again 6 months later.
Interventions
The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
Sponsors
Alameda County Behavioral Health Care Services
University of Pittsburgh
University of California, Berkeley
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18+ years * English language fluency * Presence of at least one DSM-V mental disorder for 12 months * One or more of the following sleep or circadian problems for 3 month as assessed with the Sleep and Circadian Problems Interview: * ≥30 mins to get to sleep , 3 or more nights per week * Waking in the middle of the night for ≥30 minutes, 3 or more nights per week * Obtaining less than 6 hours of sleep per night, 3 or more nights per week * Obtaining more than 9 hours of sleep per 24 hour period (i.e., nighttime sleep plus daytime napping), 3 or more nights per week * More than 2.78 hours of variability in sleep-wake schedule across one week * Bedtime later than 2 am, 3 or more nights per week * Guaranteed bed to sleep in for the duration of the treatment phase * Receiving care for SMI at ACBHCS and consent to regular communications between research team and psychiatrist and/or case manager
Exclusion criteria
* Presence of an active and progressive physical illness or neurological degenerative disease AND/OR substance abuse/dependence making participation in the study unfeasible. * Current serious suicide risk (assessed by our staff, a case manager or psychiatrist) or homicide risk (assessed by our staff, a case manager or psychiatrist) * Night shift work \>2 nights per week in the past 3 months * Pregnancy or breast-feeding * Not able/willing to participate in and/or complete the pre-treatment assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impairment (Sheehan Disability Scale) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | Sheehan Disability Scale (SDS) (sleep). 3-item. The SDS evaluates the extent to which work/school, social life, and home/ family responsibilities are impaired on a 0-10 (not at all to extremely) scale. The 3-items are summed to compute the total score and assess global functional impairment. Scores can range from 0 to 30, with higher values indicating higher impairment. |
| Disorder-Focused Composite Score (DSM-5) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | DSM-5 Cross Cutting Measure. 23-items. Individuals report how much each domain has bothered them in the last 2 weeks on a 0-4 scale (not at all to nearly every day). The total score is calculated by summing the highest score in each of the 13 domains (depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use). Total scores can range from 0 to 52, with higher scores indicating greater severity of impairment. is rated on a 5-point scale, with higher scores indicating more severe impairment. |
| Sleep and Circadian Function: PROMIS-Sleep Disturbance | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | PROMIS-Sleep Disturbance (PROMIS = Patient-Reported Outcomes Measurement Information System). The 8-item short version assesses sleep disturbance over the past 7 days, including restlessness, sleep quality, ability to fall and stay asleep, and refreshment following sleep using a 1-5 scale (not at all or never to very much or always). Scores range from 8 to 40, with higher scores indicating increased disturbance. |
| Sleep and Circadian Function: PROMIS-Sleep-Related Impairment | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | PROMIS-Sleep-Related Impairment (PROMIS = Patient-Reported Outcomes Measurement Information System). 16-item. Scores range from 16 to 80, with higher scores indicating increased disturbance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Actigraphy Measured Sleep (TST) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | Actigraphy-derived total sleep time (TST) is the total amount of sleep obtained by the participant per 24 hrs, which was recorded daily over a 1-week period per timepoint. For each participant, the mean and standard deviation (SD) of TST were calculated across the days. Group-level outcomes reflect the average of these participant-level means and SDs. |
| Daytime Activity (Actigraphy) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | Daytime activity was measured via actigraphy over 7 consecutive days per timepoint. For each participant, their daily waking activity counts were extracted, and the mean and within-person standard deviation (SD) of these counts were calculated across 7 days. Group-level outcomes reflect the average of these participant-level means and SDs. |
| Impairment (World Health Organization Disability Assessment Schedule 2.0) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | World Health Organization Disability Assessment Schedule 2.0 (WHODAS-2.0). 36-item measure that assesses disability in adults ages 18 years and older. It assesses disability across six domains on a scale from 1-5 (none to extreme or cannot do). Each item on the self-administered version of the WHODAS-2.0 asks the individual to rate how much difficulty he or she has had in specific areas of functioning during the past 30 days. Scores are summed across the six domains (cognition, mobility, self-care, getting along, life activities, and participation). Total scores range from 36 to 180, with higher scores indicating greater levels of disability. |
| Overall Health ('Healthy Days' Core Module) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | Four question 'healthy days' core module developed by the Centers for Disease Control and Prevention. A summary measure combines physically and mentally unhealthy days. An unhealthy days summary measure based on the second and third questions and estimates the overall number of recent days (in the past 30 days) when physical or mental health was not good. |
| Composite Sleep Health Score | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | Composite Sleep Health Score is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint sleep fluctuation across a 7-day sleep diary \< 1 hour), Satisfaction (Sleep quality question on PROMIS-Sleep Disturbance (PROMIS = Patient-Reported Outcomes Measurement Information System)), Alertness (Daytime sleepiness question on PROMIS-Sleep Related Impairment (PROMIS = Patient-Reported Outcomes Measurement Information System)), Timing (Mean midpoint sleep across the 7 day sleep diary between 2 and 4 AM), Efficiency (Average sleep efficiency based on the 7 day sleep diary ≥ 85%), and Duration (Total Sleep Time average based on 7 day sleep diary between 7 and 9 hours). Each dimension was dichotomized such that 1 = good /yes; 0 = poor/no). Total composite sleep health score ranges from 0 to 6, with larger values indicating better sleep health. |
| Depression (QIDS) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | QIDS (Quick Inventory of Depressive Symptoms). 16-item instrument assessing depressive symptoms. Each item is rated on a 4-point scale (0-3), with higher scores indicating greater symptom severity. Scoring involves summing the highest score from each of the 9 DSM-IV Major Depressive Disorder symptom domains (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Total scores range from 0 (Normal/No Depression) to 27 (Very Severe Depression). Higher scores indicate greater severity of depressive symptoms. |
| Means and Variability of Total Wake Time (Daily Sleep Diary) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | Total wake time (TWT), measured as minutes of wakefulness within a sleep period, was reported via sleep diary over 7 consecutive days. Each participant's mean and within-person SD of their TWT were calculated across days to assess means and night-to-night variability. Group-level outcomes reflect the average of these participant-level means and SDs. |
| Means and Variability of Bedtime (Daily Sleep Diary) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | Bedtime was reported via a 7-day daily sleep diary using a 24-hour decimal format, where times after midnight are expressed as numbers above 24 (ex. 1:30 am is 25.50). Each participant's mean and within-person SD of bedtime across 7 days were computed to capture average bedtime and variability. Group-level outcomes reflect the average of these participant-level means and SDs. |
| Means and Variability of Wake Time (Daily Sleep Diary) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | Wake times, using a 24-hour decimal format, were reported daily across 7 days. The mean and within-person SD were calculated for each participant's wake time across days. Group-level outcomes reflect the average of these participant-level means and SDs. |
| Actigraphy Measured Sleep (TWT) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | Actigraphy-derived total wake time (TWT), measured as minutes of wakefulness within a sleep period, was collected daily over a 1-week period. Each participant's mean and within-person SD were calculated across the 7 days. Group-level outcomes reflect the average of these participant-level means and SDs. |
| Means and Variability of Total Sleep Time (Daily Sleep Diary) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | Total sleep time (TST), measured as the total amount of sleep obtained by the participant, was reported via sleep diary over 7 consecutive days. Each participant's mean and within-person SD of TST were calculated to assess typical sleep duration and night-to-night variability. Group-level outcomes reflect the average of these participant-level means and SDs. |
| Substance Use (ASSIST ) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | ASSIST (Alcohol, Smoking and Substance Involvement Screening Test). Frequency of use, substance dependence, and related health, social, legal, financial, and employment problems in the past 3 months are rated on a 5-point scale (never to daily of almost daily). Problems with family and friends caused by substance use and failed attempts to cut down or quit substance use are measured on a 3-point scale (no, never, yes, in the past 3 months, yes, but not in the past 3 months). The total risk score is calculated by summing scores across all drug categories, with total scores ranging from 0 to 414. Higher scores indicate greater substance-related risks and problems. |
| Psychotic Symptoms (PSYRATS ) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | PSYRATS (Psychotic Symptom Rating Scales). Each of the 17 items is rated on a 5-point scale from 0 (absent) to 4 (severe). Scores are summed for auditory hallucinations (sum of 11 items) and delusions (sum of 6 items). Total scores range from 0 to 68, with higher scores indicating greater severity of psychotic symptoms. |
| Means and Variability of Sleep Efficiency (Daily Sleep Diary) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | Sleep efficiency (SE), calculated as total sleep time divided by time in bed, multiplied by 100, was recorded via sleep diary over 7 consecutive days. For each participant, the mean and within-person standard deviation (SD) of SE were calculated across the days to reflect an average and night-to-night variability. Group-level outcomes reflect the average of these participant-level means and SDs. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Recall Task | Post treatment, which is 9-14 weeks after the beginning of treatment, and 6-month follow-up | Participant recall of sleep coaching treatment |
| Height | Pre-treatment | To calculate BMI |
| Patient Learning Task (Application and Thoughts Subsections) | Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up | Client feedback and application of treatment |
| Useful and Utilized Questionnaire | Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up | Measure of sleep coaching elements used/useful to clients |
| Treatment Adherence Rating Scale-Therapist Version | After each treatment session filled out by therapist (8 times) | Therapist evaluation of client adherence to treatment |
| Body Weight | Pre-treatment, post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up | To calculate BMI |
| Diagnosis of Psychiatric Disorders (MINI International Neuropsychiatric Interview ) | Documenting diagnosis at baseline, 10-14 weeks after the beginning of treatment, and 6-month follow-up, no change predicted | — |
| Diagnosis of Sleep Disorders (Duke Structured Interview for Sleep Disorder, DSM-V) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | — |
| Sleep and Circadian Problems Interview | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | — |
| Insomnia Severity Index | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | — |
| Hypersomnia Severity Index | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | — |
| Therapy Process Measure | Administered at the end of Session 2 of treatment | Credibility Expectancy Questionnaire |
| Medication and Other Treatment Tracking Form | Stability in baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | — |
| Additional Screen for Sleep Apnea | Baseline Only | Snoring, tiredness/sleepiness, observed apneas, hypertension, BMI \> 35 kg/m2, age \> 50 years, neck circumference \> 40 cm, and male gender (STOP-BANG) Questionnaire. 8-item screen for obstructive sleep apnea. |
| Brief Pain Inventory (Short Form) | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up | Current symptoms of chronic pain |
| Clinic Staff Qualitative Assessment | One time at the convenience of clinic staff | Explore barriers and facilitators to implementing an evidence-based sleep treatment in a community setting |
| Client Behavior Change Interview | One time following the completion of the first post-treatment assessment | Exploration of barriers and facilitators to behavior change |
| Salivary Cytokine Assay | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up | Measure of cytokines present in saliva (e.g., Interleukin (IL) -1 beta, IL-6, IL-8, Tumor necrosis factor (TNF) alpha, and/or C-reactive protein (CRP)) to assess immune function |
| Credibility Evaluation Questionnaire (CEQ) | Session 2 and Post treatment, which is 9-14 weeks after the beginning of treatment. | Client evaluation of treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| UC-DT Usual Care, Delayed Treatment (UC-DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral. | 60 |
| TranS-C The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Transdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral. | 61 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to post or 6 month follow up | 7 | 2 |
Baseline characteristics
| Characteristic | TranS-C | Total | UC-DT |
|---|---|---|---|
| Age, Continuous | 47.97 years STANDARD_DEVIATION 11.51 | 46.72 years STANDARD_DEVIATION 12.41 | 45.45 years STANDARD_DEVIATION 13.25 |
| Annual household income | 26,537 Dollars ($) | 25,216 Dollars ($) | 24,091 Dollars ($) |
| Annual personal income | 12,636 Dollars ($) | 12,531 Dollars ($) | 12,429 Dollars ($) |
| Civil status Married/common law partner | 5 Participants | 9 Participants | 4 Participants |
| Civil status Separated/divorced/widowed | 18 Participants | 32 Participants | 14 Participants |
| Civil status Single | 38 Participants | 80 Participants | 42 Participants |
| DUKE diagnoses at pre-treatment (current) Circadian Rhythm Disorder: Advanced sleep phase type | 2 Participants | 2 Participants | 0 Participants |
| DUKE diagnoses at pre-treatment (current) Circadian Rhythm Disorder: Delayed sleep phase type | 3 Participants | 8 Participants | 5 Participants |
| DUKE diagnoses at pre-treatment (current) Circadian Rhythm Disorder: Irregular sleep-wake type | 1 Participants | 1 Participants | 0 Participants |
| DUKE diagnoses at pre-treatment (current) Circadian Rhythm Disorder: Periodic limb movement disorder | 1 Participants | 5 Participants | 4 Participants |
| DUKE diagnoses at pre-treatment (current) Circadian Rhythm Disorder: Restless leg syndrome | 2 Participants | 5 Participants | 3 Participants |
| DUKE diagnoses at pre-treatment (current) Hypersomnolence disorder | 17 Participants | 31 Participants | 14 Participants |
| DUKE diagnoses at pre-treatment (current) Insomnia disorder | 52 Participants | 101 Participants | 49 Participants |
| Education Graduate school | 3 Participants | 5 Participants | 2 Participants |
| Education High school or below | 19 Participants | 41 Participants | 22 Participants |
| Education Some college or completed college | 30 Participants | 64 Participants | 34 Participants |
| Education Vocational school | 9 Participants | 11 Participants | 2 Participants |
| Education (in years) | 13.80 Years STANDARD_DEVIATION 3.05 | 13.59 Years STANDARD_DEVIATION 3.48 | 13.38 Years STANDARD_DEVIATION 3.89 |
| Employment Full-time | 1 Participants | 2 Participants | 1 Participants |
| Employment Missing | 1 Participants | 1 Participants | 0 Participants |
| Employment Other | 1 Participants | 5 Participants | 4 Participants |
| Employment Part-time | 9 Participants | 15 Participants | 6 Participants |
| Employment Unemployed | 49 Participants | 98 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 19 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 101 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Living arrangement Alone | 8 Participants | 20 Participants | 12 Participants |
| Living arrangement Missing | 1 Participants | 1 Participants | 0 Participants |
| Living arrangement Supported housing | 35 Participants | 64 Participants | 29 Participants |
| Living arrangement With family (spouse or children) | 6 Participants | 14 Participants | 8 Participants |
| Living arrangement With friend or roommate or pet | 11 Participants | 22 Participants | 11 Participants |
| MINI Diagnosis at pre-treatment (current or past) Any anxiety disorder | 30 Participants | 57 Participants | 27 Participants |
| MINI Diagnosis at pre-treatment (current or past) Bipolar disorder | 21 Participants | 34 Participants | 13 Participants |
| MINI Diagnosis at pre-treatment (current or past) Major depressive disorder | 11 Participants | 28 Participants | 17 Participants |
| MINI Diagnosis at pre-treatment (current or past) Obsessive compulsive disorder | 9 Participants | 21 Participants | 12 Participants |
| MINI Diagnosis at pre-treatment (current or past) Post-traumatic stress disorder | 6 Participants | 18 Participants | 12 Participants |
| MINI Diagnosis at pre-treatment (current or past) Psychotic symptoms/features | 39 Participants | 81 Participants | 42 Participants |
| MINI Diagnosis at pre-treatment (current or past) Schizophrenia spectrum disorder | 26 Participants | 55 Participants | 29 Participants |
| MINI Diagnosis at pre-treatment (current or past) Substance use disorder | 19 Participants | 39 Participants | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 52 Participants | 26 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 25 Participants | 46 Participants | 21 Participants |
| Region of Enrollment United States | 61 Participants | 121 Participants | 60 Participants |
| Sex: Female, Male Female | 30 Participants | 63 Participants | 33 Participants |
| Sex: Female, Male Male | 31 Participants | 58 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 61 | 1 / 60 |
| other Total, other adverse events | 0 / 61 | 0 / 60 |
| serious Total, serious adverse events | 0 / 61 | 0 / 60 |
Outcome results
Primary
Disorder-Focused Composite Score (DSM-5)
DSM-5 Cross Cutting Measure. 23-items. Individuals report how much each domain has bothered them in the last 2 weeks on a 0-4 scale (not at all to nearly every day). The total score is calculated by summing the highest score in each of the 13 domains (depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use). Total scores can range from 0 to 52, with higher scores indicating greater severity of impairment. is rated on a 5-point scale, with higher scores indicating more severe impairment.
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Population: Although all randomized participants were included in the intent-to-treat analysis, the Number Analyzed represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC-DT | Disorder-Focused Composite Score (DSM-5) | Pre treatment | 25.57 score on a scale | Standard Deviation 10.72 |
| UC-DT | Disorder-Focused Composite Score (DSM-5) | Post treatment | 23.53 score on a scale | Standard Deviation 10.59 |
| UC-DT | Disorder-Focused Composite Score (DSM-5) | 6-month follow-up | 23.07 score on a scale | Standard Deviation 9.78 |
| TranS-C | Disorder-Focused Composite Score (DSM-5) | Pre treatment | 25.05 score on a scale | Standard Deviation 9.75 |
| TranS-C | Disorder-Focused Composite Score (DSM-5) | Post treatment | 17.00 score on a scale | Standard Deviation 11.23 |
| TranS-C | Disorder-Focused Composite Score (DSM-5) | 6-month follow-up | 18.67 score on a scale | Standard Deviation 11.38 |
Comparison: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.001Intent-to-treat, multilevel modeling
Comparison: Treatment effect on change from pre to 6-month follow-upp-value: 0.03Intent-to-treat, multilevel modeling
Primary
Impairment (Sheehan Disability Scale)
Sheehan Disability Scale (SDS) (sleep). 3-item. The SDS evaluates the extent to which work/school, social life, and home/ family responsibilities are impaired on a 0-10 (not at all to extremely) scale. The 3-items are summed to compute the total score and assess global functional impairment. Scores can range from 0 to 30, with higher values indicating higher impairment.
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Population: Although all randomized participants were included in the intent-to-treat analysis, the Number Analyzed represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC-DT | Impairment (Sheehan Disability Scale) | Pre treatment | 14.30 score on a scale | Standard Deviation 8.51 |
| UC-DT | Impairment (Sheehan Disability Scale) | Post treatment | 11.76 score on a scale | Standard Deviation 7.57 |
| UC-DT | Impairment (Sheehan Disability Scale) | 6-month follow-up | 10.51 score on a scale | Standard Deviation 8.36 |
| TranS-C | Impairment (Sheehan Disability Scale) | Pre treatment | 12.03 score on a scale | Standard Deviation 6.2 |
| TranS-C | Impairment (Sheehan Disability Scale) | Post treatment | 6.57 score on a scale | Standard Deviation 7.07 |
| TranS-C | Impairment (Sheehan Disability Scale) | 6-month follow-up | 7.00 score on a scale | Standard Deviation 6.41 |
Comparison: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.025Intent-to-treat, multilevel modeling
Comparison: Treatment effect on change from pre to 6-month follow-upp-value: 0.28Intent-to-treat, multilevel modeling
Primary
Sleep and Circadian Function: PROMIS-Sleep Disturbance
PROMIS-Sleep Disturbance (PROMIS = Patient-Reported Outcomes Measurement Information System). The 8-item short version assesses sleep disturbance over the past 7 days, including restlessness, sleep quality, ability to fall and stay asleep, and refreshment following sleep using a 1-5 scale (not at all or never to very much or always). Scores range from 8 to 40, with higher scores indicating increased disturbance.
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Population: Although all randomized participants were included in the intent-to-treat analysis, the Number Analyzed represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC-DT | Sleep and Circadian Function: PROMIS-Sleep Disturbance | PROMIS-Sleep Disturbance (Pre) | 29.02 score on a scale | Standard Deviation 6.57 |
| UC-DT | Sleep and Circadian Function: PROMIS-Sleep Disturbance | PROMIS-Sleep Disturbance (Post) | 27.33 score on a scale | Standard Deviation 7.22 |
| UC-DT | Sleep and Circadian Function: PROMIS-Sleep Disturbance | PROMIS-Sleep Disturbance (6-month follow-up) | 26.40 score on a scale | Standard Deviation 8 |
| TranS-C | Sleep and Circadian Function: PROMIS-Sleep Disturbance | PROMIS-Sleep Disturbance (Pre) | 28.26 score on a scale | Standard Deviation 6.06 |
| TranS-C | Sleep and Circadian Function: PROMIS-Sleep Disturbance | PROMIS-Sleep Disturbance (Post) | 20.88 score on a scale | Standard Deviation 8.91 |
| TranS-C | Sleep and Circadian Function: PROMIS-Sleep Disturbance | PROMIS-Sleep Disturbance (6-month follow-up) | 20.87 score on a scale | Standard Deviation 8.5 |
Comparison: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: <0.0001Intent-to-treat, multilevel modeling
Comparison: Treatment effect on change from pre to 6-month follow-upp-value: <0.0001Intent-to-treat, multilevel modeling
Primary
Sleep and Circadian Function: PROMIS-Sleep-Related Impairment
PROMIS-Sleep-Related Impairment (PROMIS = Patient-Reported Outcomes Measurement Information System). 16-item. Scores range from 16 to 80, with higher scores indicating increased disturbance.
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Population: Although all randomized participants were included in the intent-to-treat analysis, the Number Analyzed represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC-DT | Sleep and Circadian Function: PROMIS-Sleep-Related Impairment | PROMIS-Sleep-Related Impairment (Pre) | 51.02 score on a scale | Standard Deviation 14.09 |
| UC-DT | Sleep and Circadian Function: PROMIS-Sleep-Related Impairment | PROMIS-Sleep-Related Impairment (Post) | 47.22 score on a scale | Standard Deviation 14.14 |
| UC-DT | Sleep and Circadian Function: PROMIS-Sleep-Related Impairment | PROMIS-Sleep-Related Impairment (6-month follow-up) | 44.30 score on a scale | Standard Deviation 15.22 |
| TranS-C | Sleep and Circadian Function: PROMIS-Sleep-Related Impairment | PROMIS-Sleep-Related Impairment (Pre) | 47.93 score on a scale | Standard Deviation 11.8 |
| TranS-C | Sleep and Circadian Function: PROMIS-Sleep-Related Impairment | PROMIS-Sleep-Related Impairment (Post) | 35.16 score on a scale | Standard Deviation 14.01 |
| TranS-C | Sleep and Circadian Function: PROMIS-Sleep-Related Impairment | PROMIS-Sleep-Related Impairment (6-month follow-up) | 35.65 score on a scale | Standard Deviation 13.83 |
Comparison: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: <0.0001Intent-to-treat, multilevel modeling
Comparison: Treatment effect on change from pre to 6-month follow-upp-value: 0.027Intent-to-treat, multilevel modeling
Secondary
Actigraphy Measured Sleep (TST)
Actigraphy-derived total sleep time (TST) is the total amount of sleep obtained by the participant per 24 hrs, which was recorded daily over a 1-week period per timepoint. For each participant, the mean and standard deviation (SD) of TST were calculated across the days. Group-level outcomes reflect the average of these participant-level means and SDs.
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Population: Although all randomized participants were included in the intent-to-treat analysis, the Number Analyzed represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC-DT | Actigraphy Measured Sleep (TST) | TST mean at Pre-treatment | 421.35 Minutes | Standard Deviation 126.92 |
| UC-DT | Actigraphy Measured Sleep (TST) | TST variability at Pre-treatment | 132.08 Minutes | Standard Deviation 75.83 |
| UC-DT | Actigraphy Measured Sleep (TST) | TST mean at Post-treatment | 411.82 Minutes | Standard Deviation 108.28 |
| UC-DT | Actigraphy Measured Sleep (TST) | TST variability at Post-treatment | 135.38 Minutes | Standard Deviation 75.05 |
| UC-DT | Actigraphy Measured Sleep (TST) | TST mean at 6-month follow-up | 443.24 Minutes | Standard Deviation 119.47 |
| UC-DT | Actigraphy Measured Sleep (TST) | TST variability at 6-month follow-up | 144.86 Minutes | Standard Deviation 88.72 |
| TranS-C | Actigraphy Measured Sleep (TST) | TST mean at 6-month follow-up | 437.69 Minutes | Standard Deviation 137.88 |
| TranS-C | Actigraphy Measured Sleep (TST) | TST mean at Pre-treatment | 453.65 Minutes | Standard Deviation 147.28 |
| TranS-C | Actigraphy Measured Sleep (TST) | TST variability at Post-treatment | 140.06 Minutes | Standard Deviation 95.02 |
| TranS-C | Actigraphy Measured Sleep (TST) | TST variability at Pre-treatment | 132.34 Minutes | Standard Deviation 79.71 |
| TranS-C | Actigraphy Measured Sleep (TST) | TST variability at 6-month follow-up | 134.43 Minutes | Standard Deviation 96.75 |
| TranS-C | Actigraphy Measured Sleep (TST) | TST mean at Post-treatment | 427.23 Minutes | Standard Deviation 135.85 |
Comparison: TST mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.59Intent-to-treat, multilevel modeling
Comparison: TST mean (min): Treatment effect on change from pre to 6-month follow-up.p-value: 0.22Intent-to-treat, multilevel modeling
Comparison: TST variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.8Intent-to-treat, multilevel modeling
Comparison: TST variability (min): Treatment effect on change from pre to 6-month follow-up.p-value: 0.68Intent-to-treat, multilevel modeling
Secondary
Actigraphy Measured Sleep (TWT)
Actigraphy-derived total wake time (TWT), measured as minutes of wakefulness within a sleep period, was collected daily over a 1-week period. Each participant's mean and within-person SD were calculated across the 7 days. Group-level outcomes reflect the average of these participant-level means and SDs.
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Population: Although all randomized participants were included in the intent-to-treat analysis, the Number Analyzed represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC-DT | Actigraphy Measured Sleep (TWT) | TWT variability at Pre-treatment | 55.65 Minutes | Standard Deviation 51.16 |
| UC-DT | Actigraphy Measured Sleep (TWT) | TWT variability at Post-treatment | 60.36 Minutes | Standard Deviation 68.61 |
| UC-DT | Actigraphy Measured Sleep (TWT) | TWT mean at Pre-treatment | 91.06 Minutes | Standard Deviation 41.52 |
| UC-DT | Actigraphy Measured Sleep (TWT) | TWT mean at Post-treatment | 91.39 Minutes | Standard Deviation 48.65 |
| UC-DT | Actigraphy Measured Sleep (TWT) | TWT variability at 6-month follow-up | 56.22 Minutes | Standard Deviation 48.7 |
| UC-DT | Actigraphy Measured Sleep (TWT) | TWT mean at 6-month follow-up | 92.73 Minutes | Standard Deviation 41.87 |
| TranS-C | Actigraphy Measured Sleep (TWT) | TWT variability at 6-month follow-up | 41.41 Minutes | Standard Deviation 30.65 |
| TranS-C | Actigraphy Measured Sleep (TWT) | TWT mean at Pre-treatment | 94.95 Minutes | Standard Deviation 55.18 |
| TranS-C | Actigraphy Measured Sleep (TWT) | TWT variability at Pre-treatment | 54.46 Minutes | Standard Deviation 48.26 |
| TranS-C | Actigraphy Measured Sleep (TWT) | TWT mean at Post-treatment | 90.80 Minutes | Standard Deviation 44.85 |
| TranS-C | Actigraphy Measured Sleep (TWT) | TWT variability at Post-treatment | 51.72 Minutes | Standard Deviation 41.86 |
| TranS-C | Actigraphy Measured Sleep (TWT) | TWT mean at 6-month follow-up | 84.51 Minutes | Standard Deviation 45.84 |
Comparison: TWT mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.66Intent-to-treat, multilevel modeling
Comparison: TWT mean (min): Treatment effect on change from pre to 6-month follow-up.p-value: 0.19Intent-to-treat, multilevel modeling
Comparison: TWT variability (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.77Intent-to-treat, multilevel modeling
Comparison: TWT variability (min): Treatment effect on change from pre to 6-month follow-up.p-value: 0.2Intent-to-treat, multilevel modeling
Secondary
Composite Sleep Health Score
Composite Sleep Health Score is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint sleep fluctuation across a 7-day sleep diary \< 1 hour), Satisfaction (Sleep quality question on PROMIS-Sleep Disturbance (PROMIS = Patient-Reported Outcomes Measurement Information System)), Alertness (Daytime sleepiness question on PROMIS-Sleep Related Impairment (PROMIS = Patient-Reported Outcomes Measurement Information System)), Timing (Mean midpoint sleep across the 7 day sleep diary between 2 and 4 AM), Efficiency (Average sleep efficiency based on the 7 day sleep diary ≥ 85%), and Duration (Total Sleep Time average based on 7 day sleep diary between 7 and 9 hours). Each dimension was dichotomized such that 1 = good /yes; 0 = poor/no). Total composite sleep health score ranges from 0 to 6, with larger values indicating better sleep health.
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Population: Although all randomized participants were included in the intent-to-treat analysis, the Number Analyzed represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC-DT | Composite Sleep Health Score | Pre-treatment | 2.28 Score on a scale | Standard Deviation 1.29 |
| UC-DT | Composite Sleep Health Score | Post-treatment | 2.34 Score on a scale | Standard Deviation 1.33 |
| UC-DT | Composite Sleep Health Score | 6-month follow-up | 2.53 Score on a scale | Standard Deviation 1.39 |
| TranS-C | Composite Sleep Health Score | Pre-treatment | 2.54 Score on a scale | Standard Deviation 1.6 |
| TranS-C | Composite Sleep Health Score | Post-treatment | 3.45 Score on a scale | Standard Deviation 1.39 |
| TranS-C | Composite Sleep Health Score | 6-month follow-up | 3.38 Score on a scale | Standard Deviation 1.64 |
Comparison: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.002Intent-to-treat, multilevel modeling
Comparison: Treatment effect on change from pre to 6-month follow-up.p-value: 0.03Intent-to-treat, multilevel modeling
Secondary
Daytime Activity (Actigraphy)
Daytime activity was measured via actigraphy over 7 consecutive days per timepoint. For each participant, their daily waking activity counts were extracted, and the mean and within-person standard deviation (SD) of these counts were calculated across 7 days. Group-level outcomes reflect the average of these participant-level means and SDs.
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Population: Although all randomized participants were included in the intent-to-treat analysis, the Number Analyzed represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC-DT | Daytime Activity (Actigraphy) | Count Mean at Pre-treatment | 1309.74 Activity counts | Standard Deviation 532.79 |
| UC-DT | Daytime Activity (Actigraphy) | Count Variability at Pre-treatment | 379.69 Activity counts | Standard Deviation 211.65 |
| UC-DT | Daytime Activity (Actigraphy) | Count Mean at Post-treatment | 1361.19 Activity counts | Standard Deviation 532.36 |
| UC-DT | Daytime Activity (Actigraphy) | Count Variability at Post-treatment | 393.58 Activity counts | Standard Deviation 223.01 |
| UC-DT | Daytime Activity (Actigraphy) | Count Mean at 6-month follow-up | 1362.37 Activity counts | Standard Deviation 598.01 |
| UC-DT | Daytime Activity (Actigraphy) | Count Variability at 6-month follow-up | 447.2 Activity counts | Standard Deviation 257.81 |
| TranS-C | Daytime Activity (Actigraphy) | Count Mean at 6-month follow-up | 1281.35 Activity counts | Standard Deviation 667.83 |
| TranS-C | Daytime Activity (Actigraphy) | Count Mean at Pre-treatment | 1280.09 Activity counts | Standard Deviation 607.46 |
| TranS-C | Daytime Activity (Actigraphy) | Count Variability at Post-treatment | 371.08 Activity counts | Standard Deviation 310.24 |
| TranS-C | Daytime Activity (Actigraphy) | Count Variability at Pre-treatment | 394.04 Activity counts | Standard Deviation 256.07 |
| TranS-C | Daytime Activity (Actigraphy) | Count Variability at 6-month follow-up | 354.96 Activity counts | Standard Deviation 212.71 |
| TranS-C | Daytime Activity (Actigraphy) | Count Mean at Post-treatment | 1257.82 Activity counts | Standard Deviation 680.06 |
Comparison: Waking activity count mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.34Intent-to-treat, multilevel modeling
Comparison: Waking activity count mean (min): Treatment effect on change from pre to 6-month follow-up.p-value: 0.28Intent-to-treat, multilevel modeling
Comparison: Waking activity count variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.18Intent-to-treat, multilevel modeling
Comparison: Waking activity count variability (min): Treatment effect on change from pre to 6-month follow-up.p-value: 0.02Intent-to-treat, multilevel modeling
Secondary
Depression (QIDS)
QIDS (Quick Inventory of Depressive Symptoms). 16-item instrument assessing depressive symptoms. Each item is rated on a 4-point scale (0-3), with higher scores indicating greater symptom severity. Scoring involves summing the highest score from each of the 9 DSM-IV Major Depressive Disorder symptom domains (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Total scores range from 0 (Normal/No Depression) to 27 (Very Severe Depression). Higher scores indicate greater severity of depressive symptoms.
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Population: Although all randomized participants were included in the intent-to-treat analysis, the Number Analyzed represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC-DT | Depression (QIDS) | Pre-treatment | 12.50 score on a scale | Standard Deviation 4.71 |
| UC-DT | Depression (QIDS) | Post-treatment | 10.55 score on a scale | Standard Deviation 5.54 |
| UC-DT | Depression (QIDS) | 6-month follow-up | 10.67 score on a scale | Standard Deviation 4.58 |
| TranS-C | Depression (QIDS) | Pre-treatment | 12.03 score on a scale | Standard Deviation 5.15 |
| TranS-C | Depression (QIDS) | Post-treatment | 8.88 score on a scale | Standard Deviation 5.7 |
| TranS-C | Depression (QIDS) | 6-month follow-up | 8.46 score on a scale | Standard Deviation 5.03 |
Comparison: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.32Intent-to-treat, multilevel modeling
Comparison: Treatment effect on change from pre to 6-month follow-upp-value: 0.08Intent-to-treat, multilevel modeling
Secondary
Impairment (World Health Organization Disability Assessment Schedule 2.0)
World Health Organization Disability Assessment Schedule 2.0 (WHODAS-2.0). 36-item measure that assesses disability in adults ages 18 years and older. It assesses disability across six domains on a scale from 1-5 (none to extreme or cannot do). Each item on the self-administered version of the WHODAS-2.0 asks the individual to rate how much difficulty he or she has had in specific areas of functioning during the past 30 days. Scores are summed across the six domains (cognition, mobility, self-care, getting along, life activities, and participation). Total scores range from 36 to 180, with higher scores indicating greater levels of disability.
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Population: Although all randomized participants were included in the intent-to-treat analysis, the Number Analyzed represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC-DT | Impairment (World Health Organization Disability Assessment Schedule 2.0) | Pre-treatment | 81.53 score on a scale | Standard Deviation 25.56 |
| UC-DT | Impairment (World Health Organization Disability Assessment Schedule 2.0) | Post-treatment | 81.48 score on a scale | Standard Deviation 26.8 |
| UC-DT | Impairment (World Health Organization Disability Assessment Schedule 2.0) | 6-month follow-up | 73.45 score on a scale | Standard Deviation 26.14 |
| TranS-C | Impairment (World Health Organization Disability Assessment Schedule 2.0) | Pre-treatment | 76.48 score on a scale | Standard Deviation 21.38 |
| TranS-C | Impairment (World Health Organization Disability Assessment Schedule 2.0) | Post-treatment | 68.93 score on a scale | Standard Deviation 25.53 |
| TranS-C | Impairment (World Health Organization Disability Assessment Schedule 2.0) | 6-month follow-up | 66.63 score on a scale | Standard Deviation 23.17 |
Comparison: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.09Intent-to-treat, multilevel modeling
Comparison: Treatment effect on change from pre to 6-month follow-upp-value: 0.79Intent-to-treat, multilevel modeling
Secondary
Means and Variability of Bedtime (Daily Sleep Diary)
Bedtime was reported via a 7-day daily sleep diary using a 24-hour decimal format, where times after midnight are expressed as numbers above 24 (ex. 1:30 am is 25.50). Each participant's mean and within-person SD of bedtime across 7 days were computed to capture average bedtime and variability. Group-level outcomes reflect the average of these participant-level means and SDs.
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Population: Although all randomized participants were included in the intent-to-treat analysis, the Number Analyzed represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC-DT | Means and Variability of Bedtime (Daily Sleep Diary) | Bedtime mean at Pre-treatment | 22.20 hours | Standard Deviation 1.95 |
| UC-DT | Means and Variability of Bedtime (Daily Sleep Diary) | Bedtime variability at Pre-treatment | 1.39 hours | Standard Deviation 1.06 |
| UC-DT | Means and Variability of Bedtime (Daily Sleep Diary) | (Bedtime mean at Post-treatment | 22.39 hours | Standard Deviation 1.56 |
| UC-DT | Means and Variability of Bedtime (Daily Sleep Diary) | Bedtime variability at Post-treatment | 1.41 hours | Standard Deviation 1.07 |
| UC-DT | Means and Variability of Bedtime (Daily Sleep Diary) | Bedtime mean at 6-month follow-up | 22.41 hours | Standard Deviation 1.88 |
| UC-DT | Means and Variability of Bedtime (Daily Sleep Diary) | Bedtime variability at 6-month follow-up | 1.55 hours | Standard Deviation 1.32 |
| TranS-C | Means and Variability of Bedtime (Daily Sleep Diary) | Bedtime mean at 6-month follow-up | 21.96 hours | Standard Deviation 2.13 |
| TranS-C | Means and Variability of Bedtime (Daily Sleep Diary) | Bedtime mean at Pre-treatment | 22.17 hours | Standard Deviation 2.36 |
| TranS-C | Means and Variability of Bedtime (Daily Sleep Diary) | Bedtime variability at Post-treatment | 1.01 hours | Standard Deviation 0.93 |
| TranS-C | Means and Variability of Bedtime (Daily Sleep Diary) | Bedtime variability at Pre-treatment | 1.28 hours | Standard Deviation 0.79 |
| TranS-C | Means and Variability of Bedtime (Daily Sleep Diary) | Bedtime variability at 6-month follow-up | 1.00 hours | Standard Deviation 0.68 |
| TranS-C | Means and Variability of Bedtime (Daily Sleep Diary) | (Bedtime mean at Post-treatment | 22.00 hours | Standard Deviation 1.65 |
Comparison: Bedtime (BT) mean: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.1Intent-to-treat, multilevel modeling
Comparison: BT mean: Treatment effect on change from pre to 6-month follow-up.p-value: 0.04Intent-to-treat, multilevel modeling
Comparison: BT variability: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.2Intent-to-treat, multilevel modeling
Comparison: BT variability: Treatment effect on change from pre to 6-month follow-up.p-value: 0.07Intent-to-treat, multilevel modeling
Secondary
Means and Variability of Sleep Efficiency (Daily Sleep Diary)
Sleep efficiency (SE), calculated as total sleep time divided by time in bed, multiplied by 100, was recorded via sleep diary over 7 consecutive days. For each participant, the mean and within-person standard deviation (SD) of SE were calculated across the days to reflect an average and night-to-night variability. Group-level outcomes reflect the average of these participant-level means and SDs.
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Population: Although all randomized participants were included in the intent-to-treat analysis, the Number Analyzed represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC-DT | Means and Variability of Sleep Efficiency (Daily Sleep Diary) | SE mean at Pre-treatment | 77.61 percentage of sleep efficiency | Standard Deviation 11.89 |
| UC-DT | Means and Variability of Sleep Efficiency (Daily Sleep Diary) | SE variability at Pre-treatment | 12.52 percentage of sleep efficiency | Standard Deviation 7.63 |
| UC-DT | Means and Variability of Sleep Efficiency (Daily Sleep Diary) | SE mean at Post-treatment | 78.93 percentage of sleep efficiency | Standard Deviation 14.5 |
| UC-DT | Means and Variability of Sleep Efficiency (Daily Sleep Diary) | SE variability at Post-treatment | 11.86 percentage of sleep efficiency | Standard Deviation 8.49 |
| UC-DT | Means and Variability of Sleep Efficiency (Daily Sleep Diary) | SE mean at 6-month follow-up | 79.54 percentage of sleep efficiency | Standard Deviation 12.88 |
| UC-DT | Means and Variability of Sleep Efficiency (Daily Sleep Diary) | SE variability at 6-month follow-up | 11.25 percentage of sleep efficiency | Standard Deviation 6.71 |
| TranS-C | Means and Variability of Sleep Efficiency (Daily Sleep Diary) | SE mean at 6-month follow-up | 84.78 percentage of sleep efficiency | Standard Deviation 10.86 |
| TranS-C | Means and Variability of Sleep Efficiency (Daily Sleep Diary) | SE mean at Pre-treatment | 77.39 percentage of sleep efficiency | Standard Deviation 13.52 |
| TranS-C | Means and Variability of Sleep Efficiency (Daily Sleep Diary) | SE variability at Post-treatment | 10.01 percentage of sleep efficiency | Standard Deviation 7.95 |
| TranS-C | Means and Variability of Sleep Efficiency (Daily Sleep Diary) | SE variability at Pre-treatment | 11.92 percentage of sleep efficiency | Standard Deviation 6.71 |
| TranS-C | Means and Variability of Sleep Efficiency (Daily Sleep Diary) | SE variability at 6-month follow-up | 9.24 percentage of sleep efficiency | Standard Deviation 7.87 |
| TranS-C | Means and Variability of Sleep Efficiency (Daily Sleep Diary) | SE mean at Post-treatment | 84.31 percentage of sleep efficiency | Standard Deviation 10.07 |
Comparison: SE mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.03Intent-to-treat, multilevel modeling
Comparison: SE mean (min): Treatment effect on change from pre to 6-month follow-up.p-value: 0.03intent-to-treat, multilevel modeling
Comparison: SE variability (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.43Intent-to-treat, multilevel modeling
Comparison: SE variability (min): Treatment effect on change from pre to 6-month follow-up.p-value: 0.4Intent-to-treat, multilevel modeling
Secondary
Means and Variability of Total Sleep Time (Daily Sleep Diary)
Total sleep time (TST), measured as the total amount of sleep obtained by the participant, was reported via sleep diary over 7 consecutive days. Each participant's mean and within-person SD of TST were calculated to assess typical sleep duration and night-to-night variability. Group-level outcomes reflect the average of these participant-level means and SDs.
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Population: Although all randomized participants were included in the intent-to-treat analysis, the Number Analyzed represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC-DT | Means and Variability of Total Sleep Time (Daily Sleep Diary) | TST mean at Pre-treatment | 452.42 Minutes | Standard Deviation 101.37 |
| UC-DT | Means and Variability of Total Sleep Time (Daily Sleep Diary) | TST variability at Pre-treatment | 109.59 Minutes | Standard Deviation 55.14 |
| UC-DT | Means and Variability of Total Sleep Time (Daily Sleep Diary) | TST mean at Post-treatment | 459.09 Minutes | Standard Deviation 100.16 |
| UC-DT | Means and Variability of Total Sleep Time (Daily Sleep Diary) | TST variability at Post-treatment | 123.59 Minutes | Standard Deviation 79.11 |
| UC-DT | Means and Variability of Total Sleep Time (Daily Sleep Diary) | TST mean at 6-month follow-up | 465.23 Minutes | Standard Deviation 115.13 |
| UC-DT | Means and Variability of Total Sleep Time (Daily Sleep Diary) | TST variability at 6-month follow-up | 99.30 Minutes | Standard Deviation 52.38 |
| TranS-C | Means and Variability of Total Sleep Time (Daily Sleep Diary) | TST mean at 6-month follow-up | 464.90 Minutes | Standard Deviation 106.54 |
| TranS-C | Means and Variability of Total Sleep Time (Daily Sleep Diary) | TST mean at Pre-treatment | 431.06 Minutes | Standard Deviation 111.47 |
| TranS-C | Means and Variability of Total Sleep Time (Daily Sleep Diary) | TST variability at Post-treatment | 96.50 Minutes | Standard Deviation 97.84 |
| TranS-C | Means and Variability of Total Sleep Time (Daily Sleep Diary) | TST variability at Pre-treatment | 103.96 Minutes | Standard Deviation 46.37 |
| TranS-C | Means and Variability of Total Sleep Time (Daily Sleep Diary) | TST variability at 6-month follow-up | 90.87 Minutes | Standard Deviation 58.77 |
| TranS-C | Means and Variability of Total Sleep Time (Daily Sleep Diary) | TST mean at Post-treatment | 450.71 Minutes | Standard Deviation 92.77 |
Comparison: Means of Total sleep time: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.23Intent-to-treat, multilevel modeling
Comparison: Means of total sleep time: Treatment effect on change from pre to 6-month follow-upp-value: 0.09Intent-to-treat, multilevel modeling
Comparison: Variability of Total sleep time: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.19Intent-to-treat, multilevel modeling
Comparison: Variability of Total sleep time: Treatment effect on change from pre to 6-month follow-upp-value: 0.91Intent-to-treat, multilevel modeling
Secondary
Means and Variability of Total Wake Time (Daily Sleep Diary)
Total wake time (TWT), measured as minutes of wakefulness within a sleep period, was reported via sleep diary over 7 consecutive days. Each participant's mean and within-person SD of their TWT were calculated across days to assess means and night-to-night variability. Group-level outcomes reflect the average of these participant-level means and SDs.
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Population: Although all randomized participants were included in the intent-to-treat analysis, the Number Analyzed represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC-DT | Means and Variability of Total Wake Time (Daily Sleep Diary) | TWT mean at Pre-treatment | 131.89 Minutes | Standard Deviation 80.47 |
| UC-DT | Means and Variability of Total Wake Time (Daily Sleep Diary) | TWT variability at Pre-treatment | 77.85 Minutes | Standard Deviation 54.92 |
| UC-DT | Means and Variability of Total Wake Time (Daily Sleep Diary) | TWT mean at Post-treatment | 131.29 Minutes | Standard Deviation 116.57 |
| UC-DT | Means and Variability of Total Wake Time (Daily Sleep Diary) | (TWT variability at Post-treatment | 82.07 Minutes | Standard Deviation 77.64 |
| UC-DT | Means and Variability of Total Wake Time (Daily Sleep Diary) | TWT mean at 6-month follow-up | 118.92 Minutes | Standard Deviation 77.55 |
| UC-DT | Means and Variability of Total Wake Time (Daily Sleep Diary) | TWT variability at 6-month follow-up | 73.27 Minutes | Standard Deviation 47.7 |
| TranS-C | Means and Variability of Total Wake Time (Daily Sleep Diary) | TWT mean at 6-month follow-up | 83.55 Minutes | Standard Deviation 65.53 |
| TranS-C | Means and Variability of Total Wake Time (Daily Sleep Diary) | TWT mean at Pre-treatment | 124.84 Minutes | Standard Deviation 75.03 |
| TranS-C | Means and Variability of Total Wake Time (Daily Sleep Diary) | (TWT variability at Post-treatment | 61.33 Minutes | Standard Deviation 62.27 |
| TranS-C | Means and Variability of Total Wake Time (Daily Sleep Diary) | TWT variability at Pre-treatment | 74.04 Minutes | Standard Deviation 46.48 |
| TranS-C | Means and Variability of Total Wake Time (Daily Sleep Diary) | TWT variability at 6-month follow-up | 52.69 Minutes | Standard Deviation 52.56 |
| TranS-C | Means and Variability of Total Wake Time (Daily Sleep Diary) | TWT mean at Post-treatment | 84.37 Minutes | Standard Deviation 49.45 |
Comparison: TWT mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.04Intent-to-treat, multilevel modeling
Comparison: TWT mean (min): Treatment effect on change from pre to 6-month follow-up.p-value: 0.13Intent-to-treat, multilevel modeling
Comparison: TWT variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.21Intent-to-treat, multilevel modeling
Comparison: TWT variability (min): Treatment effect on change from pre to 6-month follow-up.p-value: 0.25Intent-to-treat, multilevel modeling
Secondary
Means and Variability of Wake Time (Daily Sleep Diary)
Wake times, using a 24-hour decimal format, were reported daily across 7 days. The mean and within-person SD were calculated for each participant's wake time across days. Group-level outcomes reflect the average of these participant-level means and SDs.
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Population: Although all randomized participants were included in the intent-to-treat analysis, the Number Analyzed represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC-DT | Means and Variability of Wake Time (Daily Sleep Diary) | Wake time variability at Pre-treatment | 1.42 hours | Standard Deviation 0.88 |
| UC-DT | Means and Variability of Wake Time (Daily Sleep Diary) | Wake time variability at Post-treatment | 1.61 hours | Standard Deviation 1.11 |
| UC-DT | Means and Variability of Wake Time (Daily Sleep Diary) | Wake time mean at 6-month follow-up | 7.95 hours | Standard Deviation 1.83 |
| UC-DT | Means and Variability of Wake Time (Daily Sleep Diary) | Wake time mean at Post-treatment | 8.26 hours | Standard Deviation 2.25 |
| UC-DT | Means and Variability of Wake Time (Daily Sleep Diary) | Wake time variability at 6-month follow-up | 1.22 hours | Standard Deviation 0.69 |
| UC-DT | Means and Variability of Wake Time (Daily Sleep Diary) | Wake time mean at Pre-treatment | 7.90 hours | Standard Deviation 1.83 |
| TranS-C | Means and Variability of Wake Time (Daily Sleep Diary) | Wake time variability at 6-month follow-up | 1.26 hours | Standard Deviation 0.95 |
| TranS-C | Means and Variability of Wake Time (Daily Sleep Diary) | Wake time mean at Pre-treatment | 7.31 hours | Standard Deviation 2.02 |
| TranS-C | Means and Variability of Wake Time (Daily Sleep Diary) | Wake time variability at Pre-treatment | 1.34 hours | Standard Deviation 1 |
| TranS-C | Means and Variability of Wake Time (Daily Sleep Diary) | Wake time mean at Post-treatment | 7.31 hours | Standard Deviation 1.82 |
| TranS-C | Means and Variability of Wake Time (Daily Sleep Diary) | Wake time variability at Post-treatment | 1.10 hours | Standard Deviation 1.08 |
| TranS-C | Means and Variability of Wake Time (Daily Sleep Diary) | Wake time mean at 6-month follow-up | 7.33 hours | Standard Deviation 1.74 |
Comparison: WT mean: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.39Intent-to-treat, multilevel modeling
Comparison: WT mean: Treatment effect on change from pre to 6-month follow-up.p-value: 0.96Intent-to-treat, multilevel modeling
Comparison: WT variability: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.047Intent-to-treat, multilevel modeling
Comparison: WT variability: Treatment effect on change from pre to 6-month follow-up.p-value: 0.3Intent-to-treat, multilevel modeling
Secondary
Overall Health ('Healthy Days' Core Module)
Four question 'healthy days' core module developed by the Centers for Disease Control and Prevention. A summary measure combines physically and mentally unhealthy days. An unhealthy days summary measure based on the second and third questions and estimates the overall number of recent days (in the past 30 days) when physical or mental health was not good.
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Population: Although all randomized participants were included in the intent-to-treat analysis, the Number Analyzed represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC-DT | Overall Health ('Healthy Days' Core Module) | Pre-treatment | 3.57 Days | Standard Deviation 1.17 |
| UC-DT | Overall Health ('Healthy Days' Core Module) | Post-treatment | 3.40 Days | Standard Deviation 1.26 |
| UC-DT | Overall Health ('Healthy Days' Core Module) | 6-month follow-up | 3.40 Days | Standard Deviation 1.26 |
| TranS-C | Overall Health ('Healthy Days' Core Module) | Pre-treatment | 3.44 Days | Standard Deviation 1.03 |
| TranS-C | Overall Health ('Healthy Days' Core Module) | Post-treatment | 3.37 Days | Standard Deviation 1.27 |
| TranS-C | Overall Health ('Healthy Days' Core Module) | 6-month follow-up | 3.37 Days | Standard Deviation 1.27 |
Comparison: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.46Intent-to-treat, multilevel modeling
Comparison: Treatment effect on change from pre to 6-month follow-upp-value: 0.1Intent-to-treat, multilevel modeling
Secondary
Psychotic Symptoms (PSYRATS )
PSYRATS (Psychotic Symptom Rating Scales). Each of the 17 items is rated on a 5-point scale from 0 (absent) to 4 (severe). Scores are summed for auditory hallucinations (sum of 11 items) and delusions (sum of 6 items). Total scores range from 0 to 68, with higher scores indicating greater severity of psychotic symptoms.
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Population: Although all randomized participants were included in the intent-to-treat analysis, the Number Analyzed represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC-DT | Psychotic Symptoms (PSYRATS ) | Pre-treatment | 36.60 score on a scale | Standard Deviation 5.13 |
| UC-DT | Psychotic Symptoms (PSYRATS ) | Post-treatment | 41.73 score on a scale | Standard Deviation 11.39 |
| UC-DT | Psychotic Symptoms (PSYRATS ) | 6-month follow-up | 42.58 score on a scale | Standard Deviation 9.44 |
| TranS-C | Psychotic Symptoms (PSYRATS ) | Pre-treatment | 39.60 score on a scale | Standard Deviation 14.29 |
| TranS-C | Psychotic Symptoms (PSYRATS ) | Post-treatment | 36.00 score on a scale | Standard Deviation 14.82 |
| TranS-C | Psychotic Symptoms (PSYRATS ) | 6-month follow-up | 25.80 score on a scale | Standard Deviation 11.23 |
Comparison: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.73Intent-to-treat, multilevel modeling
Comparison: Treatment effect on change from pre to 6-month follow-upp-value: 0.02intent-to-treat, multilevel modeling
Secondary
Substance Use (ASSIST )
ASSIST (Alcohol, Smoking and Substance Involvement Screening Test). Frequency of use, substance dependence, and related health, social, legal, financial, and employment problems in the past 3 months are rated on a 5-point scale (never to daily of almost daily). Problems with family and friends caused by substance use and failed attempts to cut down or quit substance use are measured on a 3-point scale (no, never, yes, in the past 3 months, yes, but not in the past 3 months). The total risk score is calculated by summing scores across all drug categories, with total scores ranging from 0 to 414. Higher scores indicate greater substance-related risks and problems.
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Population: Although all randomized participants were included in the intent-to-treat analysis, the Number Analyzed represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC-DT | Substance Use (ASSIST ) | Pre-treatment | 33.68 score on a scale | Standard Deviation 25.87 |
| UC-DT | Substance Use (ASSIST ) | Post-treatment | 14.62 score on a scale | Standard Deviation 17.15 |
| UC-DT | Substance Use (ASSIST ) | 6-month follow-up | 32.58 score on a scale | Standard Deviation 25.25 |
| TranS-C | Substance Use (ASSIST ) | Pre-treatment | 39.70 score on a scale | Standard Deviation 26.68 |
| TranS-C | Substance Use (ASSIST ) | Post-treatment | 15.35 score on a scale | Standard Deviation 17.13 |
| TranS-C | Substance Use (ASSIST ) | 6-month follow-up | 34.60 score on a scale | Standard Deviation 24.1 |
Comparison: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.p-value: 0.72intent-to-treat, multilevel modeling
Comparison: Treatment effect on change from pre to 6-month follow-upp-value: 0.74Intent-to-treat, multilevel modeling
Other Pre-specified
Additional Screen for Sleep Apnea
Snoring, tiredness/sleepiness, observed apneas, hypertension, BMI \> 35 kg/m2, age \> 50 years, neck circumference \> 40 cm, and male gender (STOP-BANG) Questionnaire. 8-item screen for obstructive sleep apnea.
Time frame: Baseline Only
Other Pre-specified
Body Weight
To calculate BMI
Time frame: Pre-treatment, post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up
Other Pre-specified
Brief Pain Inventory (Short Form)
Current symptoms of chronic pain
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up
Other Pre-specified
Client Behavior Change Interview
Exploration of barriers and facilitators to behavior change
Time frame: One time following the completion of the first post-treatment assessment
Other Pre-specified
Clinic Staff Qualitative Assessment
Explore barriers and facilitators to implementing an evidence-based sleep treatment in a community setting
Time frame: One time at the convenience of clinic staff
Other Pre-specified
Credibility Evaluation Questionnaire (CEQ)
Client evaluation of treatment
Time frame: Session 2 and Post treatment, which is 9-14 weeks after the beginning of treatment.
Other Pre-specified
Diagnosis of Psychiatric Disorders (MINI International Neuropsychiatric Interview )
Time frame: Documenting diagnosis at baseline, 10-14 weeks after the beginning of treatment, and 6-month follow-up, no change predicted
Other Pre-specified
Diagnosis of Sleep Disorders (Duke Structured Interview for Sleep Disorder, DSM-V)
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Other Pre-specified
Height
To calculate BMI
Time frame: Pre-treatment
Other Pre-specified
Hypersomnia Severity Index
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Other Pre-specified
Insomnia Severity Index
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Other Pre-specified
Medication and Other Treatment Tracking Form
Time frame: Stability in baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Other Pre-specified
Patient Learning Task (Application and Thoughts Subsections)
Client feedback and application of treatment
Time frame: Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up
Other Pre-specified
Patient Recall Task
Participant recall of sleep coaching treatment
Time frame: Post treatment, which is 9-14 weeks after the beginning of treatment, and 6-month follow-up
Other Pre-specified
Salivary Cytokine Assay
Measure of cytokines present in saliva (e.g., Interleukin (IL) -1 beta, IL-6, IL-8, Tumor necrosis factor (TNF) alpha, and/or C-reactive protein (CRP)) to assess immune function
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up
Other Pre-specified
Sleep and Circadian Problems Interview
Time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Other Pre-specified
Therapy Process Measure
Credibility Expectancy Questionnaire
Time frame: Administered at the end of Session 2 of treatment
Other Pre-specified
Treatment Adherence Rating Scale-Therapist Version
Therapist evaluation of client adherence to treatment
Time frame: After each treatment session filled out by therapist (8 times)
Other Pre-specified
Useful and Utilized Questionnaire
Measure of sleep coaching elements used/useful to clients
Time frame: Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up