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| Name | Class |
|---|---|
| Alameda County Behavioral Health Care Services | UNKNOWN |
| University of Pittsburgh | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TranS-C | Experimental | 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. |
|
| UC-DT | Active Comparator | Usual Care, Delayed Treatment (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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transdiagnostic Intervention for Sleep and Circadian Dysfunction | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
| 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. | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
| 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. | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Allison G Harvey, PhD | University of California, Berkeley | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alameda Country Behavioral Health Care Services | Oakland | California | 94605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37478529 | Derived | Callaway CA, Sarfan LD, Gumport NB, Harvey AG. The impact of module dosage on treatment response in a modular transdiagnostic intervention for sleep and circadian dysfunction (TranS-C). Behav Res Ther. 2023 Sep;168:104368. doi: 10.1016/j.brat.2023.104368. Epub 2023 Jul 5. | |
| 34264701 | Derived | Harvey AG, Dong L, Hein K, Yu SH, Martinez AJ, Gumport NB, Smith FL, Chapman A, Lisman M, Mirzadegan IA, Mullin AC, Fine E, Dolsen EA, Gasperetti CE, Bukosky J, Alvarado-Martinez CG, Kilbourne AM, Rabe-Hesketh S, Buysse DJ. A randomized controlled trial of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to improve serious mental illness outcomes in a community setting. J Consult Clin Psychol. 2021 Jun;89(6):537-550. doi: 10.1037/ccp0000650. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | UC-DT | Usual Care, Delayed Treatment (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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
|
Through study completion, an average of 6 months.
All-cause mortality, Serious, and Other Adverse Events were monitored through occasional assessment and self-report.
All-cause mortality did not occur during treatment in either intervention arm, and events were analyzed separately for each intervention arm. In the TranS-C arm, all-cause mortality occurred before the participant received the allocated treatment. In Usual Care, all-cause mortality occurred after the completion of the post-treatment assessment, but before the 6-month follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor of Clinical Psychology | Department of Psychology, University of California, Berkeley | 5104736490 | aharvey@berkeley.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2016 | Apr 1, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D012890 | Sleep |
| ID | Term |
|---|---|
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
| Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
| 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. | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
| 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. | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
| 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. | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
| 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. | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
| 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. | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
| 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. | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
| 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. | 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 | 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. | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
| 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. | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
| 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. | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
| 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. | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
| 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. | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
| 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. | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
| 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 | Credibility Expectancy Questionnaire | Administered at the end of Session 2 of treatment |
| 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 | 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. | Baseline Only |
| Brief Pain Inventory (Short Form) | Current symptoms of chronic pain | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up |
| Clinic Staff Qualitative Assessment | Explore barriers and facilitators to implementing an evidence-based sleep treatment in a community setting | One time at the convenience of clinic staff |
| Client Behavior Change Interview | Exploration of barriers and facilitators to behavior change | One time following the completion of the first post-treatment assessment |
| 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 | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up |
| Credibility Evaluation Questionnaire (CEQ) | Client evaluation of treatment | Session 2 and Post treatment, which is 9-14 weeks after the beginning of treatment. |
| Patient Recall Task | Participant recall of sleep coaching treatment | Post treatment, which is 9-14 weeks after the beginning of treatment, and 6-month follow-up |
| Patient Learning Task (Application and Thoughts Subsections) | Client feedback and application of treatment | Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up |
| Useful and Utilized Questionnaire | Measure of sleep coaching elements used/useful to clients | Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up |
| Treatment Adherence Rating Scale-Therapist Version | Therapist evaluation of client adherence to treatment | After each treatment session filled out by therapist (8 times) |
| Body Weight | To calculate BMI | Pre-treatment, post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up |
| Height | To calculate BMI | Pre-treatment |
| 32890862 | Derived | Gumport NB, Yu SH, Harvey AG. Implementing a transdiagnostic sleep and circadian intervention in a community mental health setting: A qualitative process evaluation with community stakeholders. Psychiatry Res. 2020 Nov;293:113443. doi: 10.1016/j.psychres.2020.113443. Epub 2020 Aug 31. |
| 27998295 | Derived | Harvey AG, Hein K, Dong L, Smith FL, Lisman M, Yu S, Rabe-Hesketh S, Buysse DJ. A transdiagnostic sleep and circadian treatment to improve severe mental illness outcomes in a community setting: study protocol for a randomized controlled trial. Trials. 2016 Dec 20;17(1):606. doi: 10.1186/s13063-016-1690-9. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Civil status | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| Living arrangement | Note: Supported housing includes living in board & care homes, senior housing, transitional housing, and homeless shelters. | Count of Participants | Participants |
|
| MINI Diagnosis at pre-treatment (current or past) | The Mini-International Neuropsychiatric Interview (MINI; DSM-5, Version 7.0.0 including Schizophrenia and Psychotic Disorders) was included as an evaluation of the presence of current and past Severe mental illness. Note: Comorbidity was common | Count of Participants | Participants |
|
| DUKE diagnoses at pre-treatment (current) | Duke Structured Interview for Sleep Disorders (DUKE) diagnoses at pre-treatment (current): The diagnostic measure for sleep disorders was the Duke Structured Interview for Sleep Disorders. Note: Comorbidity was common | Count of Participants | Participants |
|
| Education (in years) | Mean | Standard Deviation | Years |
|
| Annual personal income | Mean | Standard Deviation | Dollars ($) |
|
| Annual household income | Mean | Standard Deviation | Dollars ($) |
|
| OG001 | 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. |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
|
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|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
|
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
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|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of sleep efficiency | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Minutes | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Activity counts | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
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|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Days | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
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|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
|
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|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Minutes | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Minutes | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
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|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | hours | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | hours | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Minutes | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup |
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|
| Other Pre-specified | Diagnosis of Psychiatric Disorders (MINI International Neuropsychiatric Interview ) | Not Posted | Documenting diagnosis at baseline, 10-14 weeks after the beginning of treatment, and 6-month follow-up, no change predicted | Participants |
| Other Pre-specified | Diagnosis of Sleep Disorders (Duke Structured Interview for Sleep Disorder, DSM-V) | Not Posted | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | Participants |
| Other Pre-specified | Sleep and Circadian Problems Interview | Not Posted | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | Participants |
| Other Pre-specified | Insomnia Severity Index | Not Posted | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | Participants |
| Other Pre-specified | Hypersomnia Severity Index | Not Posted | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | Participants |
| Other Pre-specified | Therapy Process Measure | Credibility Expectancy Questionnaire | Not Posted | Administered at the end of Session 2 of treatment | Participants |
| Other Pre-specified | Medication and Other Treatment Tracking Form | Not Posted | Stability in baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup | Participants |
| 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. | Not Posted | Baseline Only | Participants |
| Other Pre-specified | Brief Pain Inventory (Short Form) | Current symptoms of chronic pain | Not Posted | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up | Participants |
| Other Pre-specified | Clinic Staff Qualitative Assessment | Explore barriers and facilitators to implementing an evidence-based sleep treatment in a community setting | Not Posted | One time at the convenience of clinic staff | Participants |
| Other Pre-specified | Client Behavior Change Interview | Exploration of barriers and facilitators to behavior change | Not Posted | One time following the completion of the first post-treatment assessment | Participants |
| 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 | Not Posted | Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up | Participants |
| Other Pre-specified | Credibility Evaluation Questionnaire (CEQ) | Client evaluation of treatment | Not Posted | Session 2 and Post treatment, which is 9-14 weeks after the beginning of treatment. | Participants |
| Other Pre-specified | Patient Recall Task | Participant recall of sleep coaching treatment | Not Posted | Post treatment, which is 9-14 weeks after the beginning of treatment, and 6-month follow-up | Participants |
| Other Pre-specified | Patient Learning Task (Application and Thoughts Subsections) | Client feedback and application of treatment | Not Posted | Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up | Participants |
| Other Pre-specified | Useful and Utilized Questionnaire | Measure of sleep coaching elements used/useful to clients | Not Posted | Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up | Participants |
| Other Pre-specified | Treatment Adherence Rating Scale-Therapist Version | Therapist evaluation of client adherence to treatment | Not Posted | After each treatment session filled out by therapist (8 times) | Participants |
| Other Pre-specified | Body Weight | To calculate BMI | Not Posted | Pre-treatment, post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up | Participants |
| Other Pre-specified | Height | To calculate BMI | Not Posted | Pre-treatment | Participants |
| 1 |
| 61 |
| 0 |
| 61 |
| 0 |
| 61 |
| EG001 | UC-DT | Usual Care, Delayed Treatment (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. | 1 | 60 | 0 | 60 | 0 | 60 |
Not provided
Not provided
Not provided
| Post treatment |
|
|
| 6-month follow-up |
|
|
Treatment effect on change from pre to 6-month follow-up |
| Intent-to-treat, multilevel modeling |
Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes |
| 0.03 |
| maximum likelihood estimation |
| -3.90 |
| 2-Sided |
| Superiority |
| PROMIS-Sleep Disturbance (Post) |
|
|
| PROMIS-Sleep Disturbance (6-month follow-up) |
|
|
Treatment effect on change from pre to 6-month follow-up |
| Intent-to-treat, multilevel modeling |
Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes |
| <0.0001 |
| Time by treatment interaction coeff. |
| -4.92 |
| 2-Sided |
| Superiority |
| PROMIS-Sleep-Related Impairment (Post) |
|
|
| PROMIS-Sleep-Related Impairment (6-month follow-up) |
|
|
Treatment effect on change from pre to 6-month follow-up |
| Intent-to-treat, multilevel modeling |
Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes |
| 0.027 |
| Time by treatment interaction coeff. |
| -5.37 |
| 2-Sided |
| Superiority |
| Post-treatment |
|
|
| 6-month follow-up |
|
|
Treatment effect on change from pre to 6-month follow-up |
| Intent-to-treat, multilevel modeling |
Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes |
| 0.08 |
| Time by treatment interaction coeff. |
| -1.67 |
| 2-Sided |
| Superiority |
| Post-treatment |
|
|
| 6-month follow-up |
|
|
Treatment effect on change from pre to 6-month follow-up |
| Intent-to-treat, multilevel modeling |
Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes |
| 0.74 |
| Time by treatment interaction coeff. |
| -0.08 |
| 2-Sided |
| Superiority |
| Post-treatment |
|
|
| 6-month follow-up |
|
|
Treatment effect on change from pre to 6-month follow-up |
| intent-to-treat, multilevel modeling |
Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes |
| 0.02 |
| Time by treatment interaction coeff. |
| -17.52 |
| 2-Sided |
| Superiority |
| SE variability at Pre-treatment |
|
|
| SE mean at Post-treatment |
|
|
| SE variability at Post-treatment |
|
|
| SE mean at 6-month follow-up |
|
|
| SE variability at 6-month follow-up |
|
|
SE mean (min): Treatment effect on change from pre to 6-month follow-up. |
| intent-to-treat, multilevel modeling |
Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes |
| 0.03 |
| Time by treatment interaction coeff. |
| 5.89 |
| 2-Sided |
| Superiority |
| SE variability (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment. | Intent-to-treat, multilevel modeling | Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes | 0.43 | Time by treatment interaction coeff. | -1.45 | 2-Sided | Superiority |
| SE variability (min): Treatment effect on change from pre to 6-month follow-up. | Intent-to-treat, multilevel modeling | Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes | 0.40 | Time by treatment interaction coeff. | -1.55 | 2-Sided | Superiority |
| TST variability at Pre-treatment |
|
|
| TST mean at Post-treatment |
|
|
| TST variability at Post-treatment |
|
|
| TST mean at 6-month follow-up |
|
|
| TST variability at 6-month follow-up |
|
|
TST mean (min): Treatment effect on change from pre to 6-month follow-up. |
| Intent-to-treat, multilevel modeling |
Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes |
| 0.22 |
| Time by treatment interaction coeff. |
| -28.33 |
| 2-Sided |
| Superiority |
| TST variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment. | Intent-to-treat, multilevel modeling | Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes | 0.80 | Time by treatment interaction coeff. | 4.65 | 2-Sided | Superiority |
| TST variability (min): Treatment effect on change from pre to 6-month follow-up. | Intent-to-treat, multilevel modeling | Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes | 0.68 | Time by treatment interaction coeff. | -7.57 | 2-Sided | Superiority |
| Count Variability at Pre-treatment |
|
|
| Count Mean at Post-treatment |
|
|
| Count Variability at Post-treatment |
|
|
| Count Mean at 6-month follow-up |
|
|
| Count Variability at 6-month follow-up |
|
|
|
Waking activity count mean (min): Treatment effect on change from pre to 6-month follow-up. |
| Intent-to-treat, multilevel modeling |
Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes |
| 0.28 |
| Time by treatment interaction coeff. |
| -87.15 |
| 2-Sided |
| Superiority |
| Waking activity count variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment. | Intent-to-treat, multilevel modeling | Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes | 0.18 | Time by treatment interaction coeff. | -0.15 | 2-Sided | Superiority |
| Waking activity count variability (min): Treatment effect on change from pre to 6-month follow-up. | Intent-to-treat, multilevel modeling | Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes | 0.02 | Time by treatment interaction coeff. | -0.27 | 2-Sided | Superiority |
| Post-treatment |
|
|
| 6-month follow-up |
|
|
Treatment effect on change from pre to 6-month follow-up |
| Intent-to-treat, multilevel modeling |
Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcome. |
| 0.79 |
| Time by treatment interaction coeff. |
| -1.13 |
| 2-Sided |
| Superiority |
| Post-treatment |
|
|
| 6-month follow-up |
|
|
Treatment effect on change from pre to 6-month follow-up |
| Intent-to-treat, multilevel modeling |
Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes |
| 0.10 |
| Time by treatment interaction coeff. |
| -0.34 |
| 2-Sided |
| Superiority |
| Post-treatment |
|
|
| 6-month follow-up |
|
|
Treatment effect on change from pre to 6-month follow-up. |
| Intent-to-treat, multilevel modeling |
Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes |
| 0.03 |
| Time by treatment interaction coeff. |
| 0.64 |
| 2-Sided |
| Superiority |
| TST variability at Pre-treatment |
|
|
| TST mean at Post-treatment |
|
|
| TST variability at Post-treatment |
|
|
| TST mean at 6-month follow-up |
|
|
| TST variability at 6-month follow-up |
|
|
|
Means of total sleep time: Treatment effect on change from pre to 6-month follow-up |
| Intent-to-treat, multilevel modeling |
Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes |
| 0.09 |
| Time by treatment interaction coeff. |
| 34.31 |
| 2-Sided |
| Superiority |
| Variability of Total sleep time: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment. | Intent-to-treat, multilevel modeling | Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes | 0.19 | Time by treatment interaction coeff. | -19.90 | 2-Sided | Superiority |
| Variability of Total sleep time: Treatment effect on change from pre to 6-month follow-up | Intent-to-treat, multilevel modeling | Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes | 0.91 | Time by treatment interaction coeff. | -1.76 | 2-Sided | Superiority |
| TWT variability at Pre-treatment |
|
|
| TWT mean at Post-treatment |
|
|
| (TWT variability at Post-treatment |
|
|
| TWT mean at 6-month follow-up |
|
|
| TWT variability at 6-month follow-up |
|
|
TWT mean (min): Treatment effect on change from pre to 6-month follow-up. |
| Intent-to-treat, multilevel modeling |
Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes |
| 0.13 |
| Time by treatment interaction coeff. |
| -28.56 |
| 2-Sided |
| Superiority |
| TWT variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment. | Intent-to-treat, multilevel modeling | Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes | 0.21 | Time by treatment interaction coeff. | -17.57 | 2-Sided | Superiority |
| TWT variability (min): Treatment effect on change from pre to 6-month follow-up. | Intent-to-treat, multilevel modeling | Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes | 0.25 | Time by treatment interaction coeff. | -16.05 | 2-Sided | Superiority |
| Bedtime variability at Pre-treatment |
|
|
| (Bedtime mean at Post-treatment |
|
|
| Bedtime variability at Post-treatment |
|
|
| Bedtime mean at 6-month follow-up |
|
|
| Bedtime variability at 6-month follow-up |
|
|
BT mean: Treatment effect on change from pre to 6-month follow-up. |
| Intent-to-treat, multilevel modeling |
Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes |
| 0.04 |
| Time by treatment interaction coeff. |
| -0.71 |
| 2-Sided |
| Superiority |
| BT variability: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment. | Intent-to-treat, multilevel modeling | Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes | 0.20 | Time by treatment interaction coeff. | -0.31 | 2-Sided | Superiority |
| BT variability: Treatment effect on change from pre to 6-month follow-up. | Intent-to-treat, multilevel modeling | Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes | 0.07 | Time by treatment interaction coeff. | -0.45 | 2-Sided | Superiority |
| Wake time variability at Pre-treatment |
|
|
| Wake time mean at Post-treatment |
|
|
| Wake time variability at Post-treatment |
|
|
| Wake time mean at 6-month follow-up |
|
|
| Wake time variability at 6-month follow-up |
|
|
WT mean: Treatment effect on change from pre to 6-month follow-up. |
| Intent-to-treat, multilevel modeling |
Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes |
| 0.96 |
| Time by treatment interaction coeff. |
| -0.02 |
| 2-Sided |
| Superiority |
| WT variability: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment. | Intent-to-treat, multilevel modeling | Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes | 0.047 | Time by treatment interaction coeff. | -0.39 | 2-Sided | Superiority |
| WT variability: Treatment effect on change from pre to 6-month follow-up. | Intent-to-treat, multilevel modeling | Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes | 0.30 | Time by treatment interaction coeff. | 0.20 | 2-Sided | Superiority |
| TWT variability at Pre-treatment |
|
|
| TWT mean at Post-treatment |
|
|
| TWT variability at Post-treatment |
|
|
| TWT mean at 6-month follow-up |
|
|
| TWT variability at 6-month follow-up |
|
|
TWT mean (min): Treatment effect on change from pre to 6-month follow-up. |
| Intent-to-treat, multilevel modeling |
Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes |
| 0.19 |
| Time by treatment interaction coeff. |
| -13.34 |
| 2-Sided |
| Superiority |
| TWT variability (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment. | Intent-to-treat, multilevel modeling | Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes | 0.77 | Time by treatment interaction coeff. | -0.05 | 2-Sided | Superiority |
| TWT variability (min): Treatment effect on change from pre to 6-month follow-up. | Intent-to-treat, multilevel modeling | Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes | 0.20 | Time by treatment interaction coeff. | -0.22 | 2-Sided | Superiority |