Circadian Dysregulation, Sleep Disorder
Conditions
Brief summary
The train-the-trainer (TTT) approach is a promising method of sustaining training efforts in community mental health centers (CMHCs). This study will test the implementation and effectiveness outcomes of a sleep treatment delivered by CMHC providers who are trained and supervised within CMHCs via TTT. The investigators will test two versions of the sleep treatment, a Standard version and an Adapted version that has been adapted using theory, data and stakeholder inputs to improve the fit for SMI patients treated in community mental health centers.
Detailed description
There are significant barriers to widespread implementation and sustainment of evidence-based psychological treatments (EBPTs) in community mental health centers (CMHCs), including insufficient time and funding, shortage of trainers and consultants, and staff turnover. The investigators propose to evaluate one possible solution, the train-the-trainer (TTT) approach, in the context of a transdiagnostic EBPT for sleep and circadian dysfunction-the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)- for serious mental illness (SMI) in CMHCs. This entry describes the Train-the-Trainer Phase, the second of a three-phase hybrid type 2 effectiveness-implementation trial conducted to test TranS-C in CMHCs. TTT is a training structure with multiple levels, called Generations. First, external expert trainers train an initial cohort of providers in a specific EBPT (Generation 1 providers). Next, Generation 1 providers are offered additional training in how to train others in the EBPT and become local trainers. These local trainers then train the next cohort of providers within their organization (Generation 2 providers). The Train-the-Trainer Phase builds upon the first phase, the Implementation Phase (NCT04154631), in which implementation and effectiveness outcomes of two versions of TranS-C, Standard and Adapted are compared, with CMHC providers, who are trained by treatment experts. Adapted TranS-C is a version of TranS-C designed to improve 'fit' with the CMHC context. In the Train-the-Trainer Phase, the aim is to test implementation and effectiveness outcomes of Standard and Adapted TranS-C with CMHC providers who are trained and supervised within CMHCs (i.e., Generation 2 of TTT). In the Implementation Phase, 10 CMHC clinic sites were cluster randomized to either Standard or Adapted TranS-C. Nine CMHCs continued participation into the Train-the-Trainer Phase. Within each CMHC site, patients are randomized to immediate TranS-C or to Usual Care followed by Delayed Treatment (UC-DT). Generation 2 patients (n=130) will be assessed pre, mid and post-treatment and at 6 month follow-up. UC Berkeley will coordinate the research, facilitate implementation, collect data, etc. Generation 2 providers (n=60), trained by local trainers within an established network of CMHCs, will implement TranS-C and will be assessed at pre and post-treatment. SA1 is to confirm that both Standard vs. Adapted TranS-C, compared to UC-DT, improve sleep and circadian functioning and reduce functional impairment and disorder-focused psychiatric symptoms for Generation 2 patients. SA2 is to evaluate the fit, to the CMHC context, of Standard vs. Adapted TranS-C via Generation 2 provider ratings of acceptability, appropriateness and feasibility. SA3 will examine if better fit, operationalized via Generation 2 provider ratings of acceptability, mediates the relationship between treatment condition and Generation 2 patient outcome. This research will determine if (1) sleep and circadian problems can be effectively addressed in SMI by CMHC providers trained and supervised within CMHCs via the train-the-trainer approach, (2) test two variations of TranS-C that each have unique advantages and focus on community providers and typical community patients.
Interventions
TranS-C is a psychosocial treatment designed to improve sleep and circadian functioning. It is a modular, psychosocial, skills-based approach. In this study, two version of TranS-C will be tested: Standard and Adapted.
The Adapted version was derived from Standard TranS-C. It was developed to improve the fit of the treatment with the CMHC context.
Usual care in the partner CMHCs typically starts with a case manager who co-ordinates care and refers each client for a medication review and to various rehabilitation programs (e.g., health care, housing, nutrition, finding a job, peer monitoring).
Sponsors
University of California, Berkeley
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
The assessment team will be blind to group allocation at post-treatment and six-month follow-up
Intervention model description
CMHC sites will be cluster randomized to either Standard TranS-C or Adapted TranS-C. Then within each CMHC site, patients will be randomized to either TranS-C or to Usual Care followed by Delayed Treatment (UC-DT).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The inclusion criteria for the CMHC local trainers are: * Employed in participating CMHCs * Completed a Generation 1 TranS-C training (i.e., led by UC Berkeley expert trainers) * Volunteer to participate and formally consent to participate The inclusion criteria for CMHCs are: * Publicly funded adult mental health outpatient services * Support from CMHC leadership The inclusion criteria for CMHC providers are: * Employed or able to deliver client-facing services to CMHC clients * Interest in learning and delivering TranS-C * Volunteer to participate and formally consent to participate Consumers must meet the following inclusion criteria: * Aged 18 years and older * Meet criteria for an SMI per self-report and confirmed by referring provider or administration of the Mini International Neuropsychiatric Interview (MINI) (DSM-5, Version 7.0.0) by a licensed clinical social worker on the research team * Exhibit a sleep or circadian disturbance as determined by endorsing 4 quite a bit or 5 very much (or the equivalent for reverse scored items) on one or more PROMIS-SD questions * Receiving the standard of care for the SMI and consent to regular communications between the research team and provider * Consent to access their medical record and participate in assessments * Guaranteed place to sleep for at least 2 months that is not a shelter
Exclusion criteria
* Presence of an active and progressive physical illness or neurological degenerative disease directly related to the onset and course of the sleep and circadian dysfunction, or making participation in the study unfeasible based on confirmation from the treating clinician and/or medical record * Presence of substance abuse/dependence only if it makes participation in the study unfeasible * Current active intent or plan to commit suicide (those with suicidal ideation are eligible) only if it makes participation in the study unfeasible, or homicide risk * Night shift work \>2 nights per week in the past 3 months * Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Baseline, mid-treatment (2/4 weeks post-baseline), post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up. | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale. The 8-item short version scale assesses perceived sleep problems (e.g., sleep quality, perception of sleep difficulties) over a 7-day period. Items are rated on a 5-point scale ranging from 1 (not at all) to 5 (very much). Raw scores are summed to produce a single score, resulting in a range from 8 to 40. Raw scores are converted to t-scores using treatment manuals. T-scores range from 30.5 to 77.5. A T-score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate worse sleep disturbance. |
| Provider-level Outcome: Acceptability Intervention Measure | Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS- C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C). | Assesses provider perceptions of the acceptability of the treatment intervention using a self-report questionnaire. The 4-item scale is rated on a 5-point scale from 1 (completely disagree) to 5 (completely agree). A total score is calculated by averaging all four items. Total scores range from 1 to 5, with higher scores indicating greater perceptions of acceptability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-level Outcome: Sheehan Disability Scale | Baseline, post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up. | The Sheehan Disability Scale (SDS) assesses impairment in work/school, social, and family life. Items are rated on a scale from 0 (not at all) to 10 (extremely). Items are summed to produce a single score. Scores range from 0 to 30, with higher scores indicating higher functional impairment. |
| Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Baseline, post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up. | The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure (DSM-5) assesses psychiatric symptoms across 13 mental health domains. Participants rate on a 5-point scale how often they were bothered by each symptom on a scale from 0 (not at all) to 4 (nearly every day). Scores range from 0 to 52, with higher scores indicating more severe symptoms. |
| Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Baseline, mid-treatment (2/4 weeks post-baseline), post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up. | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Impairment Scale. The 8-item short version scale assesses perceived sleep problems during waking hours (e.g., alertness, sleepiness, tiredness) over a 7-day period. Items are rated on a 5-point scale ranging from 1 (not at all) to 5 (very much). Raw scores are summed to produce a single score, resulting in a range from 8 to 40. Raw scores are converted to t-scores using treatment manuals. T-scores range from 30.1 to 80.1. A T-score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate worse sleep-related impairment. |
| Provider-level Outcome: Feasibility of Intervention Measure | Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS-C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C). | Assesses provider perceptions of the feasibility of the treatment intervention using a self-report questionnaire. The 4- item scale is rated on a 5-point scale from 1 (completely disagree) to 5 (completely agree). A total score is calculated by averaging all four items. Total scores range from 1 to 5, with higher scores indicating greater perceptions of feasibility. |
| Provider-level Outcome: Intervention Appropriateness Measure | Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS- C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C). | Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire. The 4-item scale is rated on a 5-point scale from 1 (completely disagree) to 5 (completely agree). A total score is calculated by averaging all four items. Total scores range from 1 to 5, with higher scores indicating greater perceptions of appropriateness. |
| Patient-level Outcome: Composite Sleep Health Score | Baseline, mid-treatment (2/4 weeks post-baseline), post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient-level Outcome: Duke Checklist of Medical Conditions & Symptoms | Once at baseline. | Assesses physical illness or neurological degenerative disease directly related to the onset and course of the sleep and circadian dysfunction. |
| Provider-level Outcome: Checklist of Modules Delivered | Once at each session between patient and provider. | Assesses which treatment modules were delivered by the providers using a self-report checklist. |
| Provider-level Outcome: Adaptations to Evidence-Based Practices Scale | Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment. | Assesses ad hoc modifications the provider made to the treatment using a self-report questionnaire. |
| Provider-level Outcome: Use of TranS-C Assessment | Once during the 1 year sustainment phase. | Assesses if providers continue to use TranS-C in a self-report questionnaire. |
| Provider-level Outcome: Session Attendance and Duration Log | Once at each session between patient and provider. | Collect session date and duration (length of session). |
| Provider-level Outcome: Training Evaluation/Knowledge Test | Through the first 2.5 years of the study, an average of 4 per month | Provider evaluation of the training; provider knowledge of content covered in the training; provider willingness and confidence in delivering TranS-C. |
| Patient-level Outcome: Midpoint of Sleep Measure | Change from baseline, to mid-treatment, which is 2 or 4 weeks after the beginning of treatment, to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. | Assesses circadian functioning by calculating the midpoint between falling asleep time and rise time. |
| Provider-level Outcome: Number of TranS-C Sessions | Once per patient at posttreatment, which is 6 or 10 weeks after the beginning of treatment | Number of sessions delivered to each enrolled patient by each provider. |
| Facilitator-level Outcome: Implementation Log | Up to 30 months | Weekly record of facilitator activities, amount of time per activity, county, year, type of communication, implementation strategies, target(s), intended outcome(s). |
| Facilitator-level Outcome: Meeting Log | Up to 30 months | Weekly record of community meeting details as applicable, including: county, generation, level of contact (i.e., leadership, providers), type/modality of contact, length of meeting, number of attendees, recording, general description, standardized description, main presenter and role of UC Berkeley staff. |
| Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance | Change from baseline to mid-treatment, which is 2 or 4 weeks after the beginning of treatment | Assesses perceived functional impairments related to sleep problems using a self-report questionnaire. The minimum value is 8. The maximum value is 40. Higher scores mean more sleep disturbance (worse outcome). |
| Provider-level Outcome: Acceptability Intervention Measure | Change from baseline to mid-treatment, which is 2 or 4 weeks after the beginning of treatment for each client | Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire and provider feedback. |
| Provider-level Outcome: Gold Standard Training Elements | Through the first 2.5 years of the study, an average of 4 per month | Extent of gold standard training elements present in each training session, with respect to content and technique. |
| Patient-level Outcome: Alcohol Intake | Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. | Assesses past 30-day quantity and frequency of alcohol intake using a self-report questionnaire. |
| Patient-level Outcome: Substances Intake | Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. | Assesses past 30-day frequency of substance use using a self-report questionnaire. |
| Patient-level Outcome: Tobacco Intake | Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. | Assesses past 30-day quantity and frequency of tobacco intake using a self-report questionnaire. |
| Patient-level Outcome: Caffeine Intake | Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. | Assesses past 30-day quantity and frequency of caffeine intake using a self-report questionnaire. |
| Patient-level Outcome: Suicidal Ideation Questionnaire | Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. | Assesses past 30-day suicidal ideation using a self-report questionnaire. |
| Patient-level Outcome: Credibility Expectancy Questionnaire | Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment. | Measures the credibility and expectation of improvement from TranS-C. The questionnaire includes 4 items. |
| Patient-level Outcome: Utilization Questionnaire | Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment. | Measures the elements of TranS-C that are most used. |
Countries
United States
Participant flow
Pre-assignment details
CMHCs (the units) were randomized to Standard TranS-C or Adapted TranS-C but CMHCs were not further randomized to UC-DT or Immediate TranS-C. Patients within a CMHC were randomized to UC-DT or immediate TranS-C. Therefore, only Standard TranS-C and Adapted TranS-C are reported in the participant flow so that units (i.e., CMHCS) are not counted more than once across a row.
Participants by arm
| Arm | Count |
|---|---|
| Standard TranS-C (Immediate) Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C): TranS-C is a psychosocial treatment designed to improve sleep and circadian functioning. It is a modular, psychosocial, skills-based approach. In this study, two version of TranS-C will be tested: Standard and Adapted.
Standard TranS-C is modularized and delivered across eight 50-minute, weekly, individual sessions. It is comprised of 4 cross-cutting interventions featured in every session; 4 core modules that apply to the vast majority of patients; and 7 optional modules used less commonly, depending on the presentation.
Participants in this group received Standard TranS-C immediately. | 8 |
| Adapted TranS-C (Immediate) Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C): The Adapted version was derived from Standard TranS-C. It was developed to improve the fit of the treatment with the CMHC context.
The process for developing Adapted TranS-C has been iterative and grounded in theory, data and stakeholder feedback. The core elements of the evidence-based theory of change underpinning TranS-C have been retained. Adapted TranS-C is delivered in four 20-minute, weekly, individual sessions.
Participants in this group received Adapted TranS-C immediately. | 70 |
| Standard TranS-C (UC-DT) Usual Care Delayed Treatment. Usual care in the partner CMHCs starts with a case manager who co-ordinates care and refers each client for a medication review and to various rehabilitation programs (e.g., health care, housing, nutrition, finding a job, peer monitoring).
Participants in this group received usual care followed by delayed treatment with Standard TranS-C. | 8 |
| Adapted TranS-C (UC-DT) Usual Care Delayed Treatment. Usual care in the partner CMHCs starts with a case manager who co-ordinates care and refers each client for a medication review and to various rehabilitation programs (e.g., health care, housing, nutrition, finding a job, peer monitoring).
Participants in this group received usual care followed by delayed treatment with Adapted TranS-C. | 57 |
| Standard TranS-C - Providers Standard TranS-C is modularized and delivered across eight 50-minute, weekly, individual sessions. It is comprised of 4 cross-cutting interventions featured in every session; 4 core modules that apply to the vast majority of patients; and 7 optional modules used less commonly, depending on the presentation.
These data reflect the characteristics of providers who delivered Standard TranS-C. | 6 |
| Adapted TranS-C - Providers The process for developing Adapted TranS-C has been iterative and grounded in theory, data and stakeholder feedback. The core elements of the evidence-based theory of change underpinning TranS-C have been retained. Adapted TranS-C is delivered in four 20-minute, weekly, individual sessions.
These data reflect the characteristics of providers who delivered Adapted TranS-C. | 47 |
| Total | 196 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Patients lost to post or 6-month follow-up | 12 | 64 |
Baseline characteristics
| Characteristic | Standard TranS-C - Providers | Total | Adapted TranS-C (Immediate) | Adapted TranS-C - Providers | Standard TranS-C (UC-DT) | Standard TranS-C (Immediate) | Adapted TranS-C (UC-DT) |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 39.50 Years STANDARD_DEVIATION 12.4 | 43.52 Years STANDARD_DEVIATION 13.72 | 43.26 Years STANDARD_DEVIATION 15.35 | 40.21 Years STANDARD_DEVIATION 10.19 | 46.25 Years STANDARD_DEVIATION 8.21 | 43.75 Years STANDARD_DEVIATION 13.18 | 43.43 Years STANDARD_DEVIATION 14.43 |
| Annual Household Income <$10,000 | — | 21 Participants | 7 Participants | — | 0 Participants | 1 Participants | 13 Participants |
| Annual Household Income $10,000-$20,000 | — | 27 Participants | 14 Participants | — | 1 Participants | 3 Participants | 9 Participants |
| Annual Household Income $20,000-$30,000 | — | 15 Participants | 6 Participants | — | 2 Participants | 3 Participants | 4 Participants |
| Annual Household Income $30,000-$40,000 | — | 7 Participants | 5 Participants | — | 0 Participants | 0 Participants | 2 Participants |
| Annual Household Income $40,000-$50,000 | — | 7 Participants | 4 Participants | — | 1 Participants | 1 Participants | 1 Participants |
| Annual Household Income >= $50,000 | — | 32 Participants | 14 Participants | — | 1 Participants | 0 Participants | 17 Participants |
| Annual Household Income I don't know my income | — | 32 Participants | 18 Participants | — | 3 Participants | 0 Participants | 11 Participants |
| Annual Household Income Missing/ declined to answer | — | 2 Participants | 2 Participants | — | 0 Participants | 0 Participants | 0 Participants |
| Caseload | 33.00 Number of patients STANDARD_DEVIATION 37.24 | 33.26 Number of patients STANDARD_DEVIATION 39.17 | — | 33.29 Number of patients STANDARD_DEVIATION 40.18 | — | — | — |
| Civil Status Missing/ declined to answer | — | 1 Participants | 0 Participants | — | 0 Participants | 0 Participants | 1 Participants |
| Civil Status Other/ category not listed | — | 1 Participants | 0 Participants | — | 1 Participants | 0 Participants | 0 Participants |
| Civil Status Partnered | — | 28 Participants | 16 Participants | — | 2 Participants | 1 Participants | 9 Participants |
| Civil Status Unpartnered | — | 113 Participants | 54 Participants | — | 5 Participants | 7 Participants | 47 Participants |
| Degree Type Marriage and Family Therapy | 0 Participants | 4 Participants | — | 4 Participants | — | — | — |
| Degree Type Medical | 0 Participants | 1 Participants | — | 1 Participants | — | — | — |
| Degree Type Missing/declined to answer | 1 Participants | 13 Participants | — | 12 Participants | — | — | — |
| Degree Type Nursing | 0 Participants | 8 Participants | — | 8 Participants | — | — | — |
| Degree Type Other/category not listed | 0 Participants | 4 Participants | — | 4 Participants | — | — | — |
| Degree Type Psychology | 1 Participants | 5 Participants | — | 4 Participants | — | — | — |
| Degree Type Social Work | 4 Participants | 19 Participants | — | 15 Participants | — | — | — |
| Education High school graduate or below | — | 14 Participants | 6 Participants | — | 0 Participants | 3 Participants | 5 Participants |
| Education Missing/ declined to answer | — | 3 Participants | 2 Participants | — | 0 Participants | 0 Participants | 1 Participants |
| Education Other/ category not listed | — | 1 Participants | 0 Participants | — | 1 Participants | 0 Participants | 0 Participants |
| Education Some or completed college or vocational school | — | 87 Participants | 45 Participants | — | 4 Participants | 4 Participants | 34 Participants |
| Education Some or completed graduate school | — | 38 Participants | 17 Participants | — | 3 Participants | 1 Participants | 17 Participants |
| Employment Full-time | — | 28 Participants | 13 Participants | — | 3 Participants | 1 Participants | 11 Participants |
| Employment Not employed | — | 86 Participants | 45 Participants | — | 2 Participants | 5 Participants | 34 Participants |
| Employment Other/ category not listed | — | 7 Participants | 2 Participants | — | 2 Participants | 0 Participants | 3 Participants |
| Employment Part-time | — | 22 Participants | 10 Participants | — | 1 Participants | 2 Participants | 9 Participants |
| Employment Duration | 1.20 Years STANDARD_DEVIATION 1.1 | 4.86 Years STANDARD_DEVIATION 5.98 | — | 5.41 Years STANDARD_DEVIATION 6.23 | — | — | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 40 Participants | 18 Participants | 8 Participants | 1 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 140 Participants | 52 Participants | 25 Participants | 6 Participants | 4 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 16 Participants | 0 Participants | 14 Participants | 1 Participants | 0 Participants | 0 Participants |
| Government Assistance Food Stamps | — | 30 Participants | 14 Participants | — | 1 Participants | 2 Participants | 13 Participants |
| Government Assistance Medicaid | — | 50 Participants | 26 Participants | — | 2 Participants | 2 Participants | 20 Participants |
| Government Assistance Medicare | — | 12 Participants | 8 Participants | — | 0 Participants | 1 Participants | 3 Participants |
| Government Assistance Missing/declined to answer | — | 43 Participants | 21 Participants | — | 4 Participants | 1 Participants | 17 Participants |
| Government Assistance Other/category not listed | — | 21 Participants | 10 Participants | — | 1 Participants | 3 Participants | 7 Participants |
| Government Assistance Social Security | — | 16 Participants | 6 Participants | — | 0 Participants | 3 Participants | 7 Participants |
| Government Assistance Supplemental Nutrition Assistance Program | — | 15 Participants | 8 Participants | — | 0 Participants | 1 Participants | 6 Participants |
| Government Assistance Supplemental Security Income/ Social Security Disability Insurance | — | 27 Participants | 15 Participants | — | 0 Participants | 2 Participants | 10 Participants |
| Government Assistance Unemployment | — | 3 Participants | 2 Participants | — | 0 Participants | 0 Participants | 1 Participants |
| Licensure Licensed | 3 Participants | 27 Participants | — | 24 Participants | — | — | — |
| Licensure Missing/ declined to answer | 1 Participants | 13 Participants | — | 12 Participants | — | — | — |
| Licensure Not Licensed | 2 Participants | 13 Participants | — | 11 Participants | — | — | — |
| Living Arrangement Alone | — | 27 Participants | 14 Participants | — | 0 Participants | 2 Participants | 11 Participants |
| Living Arrangement Missing/ declined to answer | — | 0 Participants | 0 Participants | — | 0 Participants | 0 Participants | 0 Participants |
| Living Arrangement Other/ category not listed | — | 3 Participants | 1 Participants | — | 0 Participants | 0 Participants | 2 Participants |
| Living Arrangement Supportive housing | — | 10 Participants | 4 Participants | — | 0 Participants | 0 Participants | 6 Participants |
| Living Arrangement With family | — | 81 Participants | 38 Participants | — | 7 Participants | 5 Participants | 31 Participants |
| Living Arrangement With friend or roommate or With friend or roommate or pet | — | 22 Participants | 13 Participants | — | 1 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 7 Participants | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 11 Participants | 0 Participants | 7 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 32 Participants | 12 Participants | 1 Participants | 2 Participants | 3 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 23 Participants | 12 Participants | 1 Participants | 1 Participants | 0 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 15 Participants | 6 Participants | 0 Participants | 2 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 25 Participants | 3 Participants | 14 Participants | 1 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 1 Participants | 83 Participants | 32 Participants | 24 Participants | 2 Participants | 2 Participants | 22 Participants |
| Region of Enrollment United States | 6 participants | 196 participants | 70 participants | 47 participants | 8 participants | 8 participants | 57 participants |
| Self-reported Diagnosis Anxiety disorders | — | 72 Participants | 30 Participants | — | 5 Participants | 3 Participants | 34 Participants |
| Self-reported Diagnosis Bipolar Disorder | — | 25 Participants | 15 Participants | — | 1 Participants | 1 Participants | 8 Participants |
| Self-reported Diagnosis Dissociative disorders | — | 0 Participants | 0 Participants | — | 0 Participants | 0 Participants | 0 Participants |
| Self-reported Diagnosis Feeding and eating disorders | — | 0 Participants | 0 Participants | — | 0 Participants | 0 Participants | 0 Participants |
| Self-reported Diagnosis Major Depressive Disorder | — | 66 Participants | 31 Participants | — | 3 Participants | 4 Participants | 28 Participants |
| Self-reported Diagnosis Missing/declined to answer | — | 15 Participants | 7 Participants | — | 0 Participants | 1 Participants | 7 Participants |
| Self-reported Diagnosis Neurodevelopmental disorders | — | 22 Participants | 10 Participants | — | 0 Participants | 1 Participants | 11 Participants |
| Self-reported Diagnosis Obsessive- compulsive and related disorders | — | 5 Participants | 3 Participants | — | 0 Participants | 0 Participants | 2 Participants |
| Self-reported Diagnosis Other/category not listed | — | 3 Participants | 1 Participants | — | 2 Participants | 0 Participants | 0 Participants |
| Self-reported Diagnosis Personality disorders | — | 2 Participants | 2 Participants | — | 0 Participants | 0 Participants | 0 Participants |
| Self-reported Diagnosis Psychosis | — | 36 Participants | 20 Participants | — | 0 Participants | 3 Participants | 13 Participants |
| Self-reported Diagnosis Substance-related and addictive disorders | — | 5 Participants | 3 Participants | — | 0 Participants | 0 Participants | 2 Participants |
| Self-reported Diagnosis Trauma and stressor-related disorders | — | 33 Participants | 14 Participants | — | 1 Participants | 1 Participants | 17 Participants |
| Sex/Gender, Customized Female | 5 Participants | 128 Participants | 42 Participants | 33 Participants | 4 Participants | 5 Participants | 39 Participants |
| Sex/Gender, Customized Male | 0 Participants | 55 Participants | 28 Participants | 2 Participants | 4 Participants | 3 Participants | 18 Participants |
| Sex/Gender, Customized Missing/declined to answer | 1 Participants | 13 Participants | 0 Participants | 12 Participants | 0 Participants | 0 Participants | 0 Participants |
| Therapeutic Approach Client Centered | 5 Participants | 34 Participants | — | 29 Participants | — | — | — |
| Therapeutic Approach Cognitive Behavioral Therapy | 2 Participants | 22 Participants | — | 20 Participants | — | — | — |
| Therapeutic Approach Family Systems | 0 Participants | 8 Participants | — | 8 Participants | — | — | — |
| Therapeutic Approach Humanistic | 1 Participants | 8 Participants | — | 7 Participants | — | — | — |
| Therapeutic Approach Integrative/Holistic | 0 Participants | 2 Participants | — | 2 Participants | — | — | — |
| Therapeutic Approach Missing/declined to answer | 1 Participants | 14 Participants | — | 13 Participants | — | — | — |
| Therapeutic Approach Psychodynamic | 1 Participants | 12 Participants | — | 11 Participants | — | — | — |
| Years Since Degree Earned | 6.40 Years STANDARD_DEVIATION 6.43 | 9.26 Years STANDARD_DEVIATION 9.39 | — | 9.63 Years STANDARD_DEVIATION 9.69 | — | — | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 70 | 0 / 8 | 0 / 57 | 0 / 6 | 0 / 47 |
| other Total, other adverse events | 0 / 8 | 0 / 70 | 0 / 8 | 0 / 57 | 0 / 6 | 0 / 47 |
| serious Total, serious adverse events | 0 / 8 | 0 / 70 | 0 / 8 | 0 / 57 | 0 / 6 | 0 / 47 |
Outcome results
Primary
Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale. The 8-item short version scale assesses perceived sleep problems (e.g., sleep quality, perception of sleep difficulties) over a 7-day period. Items are rated on a 5-point scale ranging from 1 (not at all) to 5 (very much). Raw scores are summed to produce a single score, resulting in a range from 8 to 40. Raw scores are converted to t-scores using treatment manuals. T-scores range from 30.5 to 77.5. A T-score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate worse sleep disturbance.
Time frame: Baseline, mid-treatment (2/4 weeks post-baseline), post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
Population: Mid-treatment and 6-month follow-up assessments were collected following TranS-C but were not collected following Usual Care (UC-DT). To increase the sample size, analyses comparing Standard vs. Adapted TranS-C collapsed over immediate and UC-DT conditions (using the assessments collected after the UC-DT group started TranS-C at mid-treatment, post-treatment, and 6-month follow-up). An additional analysis also collapsed across all conditions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Baseline | 66.67 T-score | Standard Deviation 6.44 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | 6-month follow-up | 52.35 T-score | Standard Deviation 5.83 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Post-treatment | 51.05 T-score | Standard Deviation 15.23 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Mid-treatment | 49.55 T-score | Standard Deviation 2.33 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Baseline | 62.21 T-score | Standard Deviation 7.73 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Mid-treatment | 53.81 T-score | Standard Deviation 9.58 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Post-treatment | 55.06 T-score | Standard Deviation 10.76 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | 6-month follow-up | 52.48 T-score | Standard Deviation 10.34 |
| Standard TranS-C (UC-DT) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Post-treatment | 61.48 T-score | Standard Deviation 10.37 |
| Standard TranS-C (UC-DT) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Baseline | 60.54 T-score | Standard Deviation 5.63 |
| Adapted TranS-C (UC-DT) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Baseline | 62.24 T-score | Standard Deviation 7.34 |
| Adapted TranS-C (UC-DT) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Post-treatment | 61.04 T-score | Standard Deviation 8.52 |
| Immediate TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Mid-treatment | 53.60 T-score | Standard Deviation 9.39 |
| Immediate TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | 6-month follow-up | 52.47 T-score | Standard Deviation 10.07 |
| Immediate TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Baseline | 62.71 T-score | Standard Deviation 7.69 |
| Immediate TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Post-treatment | 54.74 T-score | Standard Deviation 11.04 |
| UC-DT | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Post-treatment | 61.08 T-score | Standard Deviation 8.59 |
| UC-DT | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Baseline | 62.05 T-score | Standard Deviation 7.14 |
| Standard TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | 6-month follow-up | 54.86 T-score | Standard Deviation 6.74 |
| Standard TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Mid-treatment | 50.08 T-score | Standard Deviation 2.65 |
| Standard TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Baseline | 63.81 T-score | Standard Deviation 6.66 |
| Standard TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Post-treatment | 54.21 T-score | Standard Deviation 12.22 |
| Adapted TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Baseline | 62.23 T-score | Standard Deviation 7.52 |
| Adapted TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Mid-treatment | 55.10 T-score | Standard Deviation 9.27 |
| Adapted TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | 6-month follow-up | 53.54 T-score | Standard Deviation 10.05 |
| Adapted TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Post-treatment | 55.21 T-score | Standard Deviation 11.18 |
| TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | 6-month follow-up | 53.63 T-score | Standard Deviation 9.84 |
| TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Post-treatment | 55.12 T-score | Standard Deviation 11.19 |
| TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Mid-treatment | 54.80 T-score | Standard Deviation 9.08 |
| TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep DisturbanceMeasurement Information System - Sleep Disturbance | Baseline | 62.40 T-score | Standard Deviation 7.42 |
Comparison: Immediate TranS-C (Standard/Adapted combined) versus UC-DT on change in sleep disturbance from pre to post.p-value: <0.001Intent-to-treat, multilevel modeling
p-value: 0.52Intent-to-treat, multilevel modeling
Comparison: Acceptability of intervention measure (AIM) predicting sleep disturbance.p-value: 0.02Regression, Linear
Comparison: Appropriateness of intervention measure (IAM) predicting sleep disturbance.p-value: 0.04Regression, Linear
Comparison: Feasibility of intervention measure (FIM) predicting sleep disturbance.p-value: 0.001Regression, Linear
Primary
Provider-level Outcome: Acceptability Intervention Measure
Assesses provider perceptions of the acceptability of the treatment intervention using a self-report questionnaire. The 4-item scale is rated on a 5-point scale from 1 (completely disagree) to 5 (completely agree). A total score is calculated by averaging all four items. Total scores range from 1 to 5, with higher scores indicating greater perceptions of acceptability.
Time frame: Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS- C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C).
Population: Acceptability Intervention Measure was collected only from providers. To increase the sample size, and because providers treated patients who could have been in either the immediate or UC-DT conditions, we analyzed by collapsing across immediate and UC-DT for providers. For some analyses, data were collapsed across Standard and Adapted TranS-C. This measure was not assessed following usual care.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard TranS-C (Immediate) | Provider-level Outcome: Acceptability Intervention Measure | Baseline | 4.90 score on a scale | Standard Deviation 0.22 |
| Standard TranS-C (Immediate) | Provider-level Outcome: Acceptability Intervention Measure | Mid-treatment | 5.00 score on a scale | Standard Deviation 0 |
| Standard TranS-C (Immediate) | Provider-level Outcome: Acceptability Intervention Measure | Post-treatment | 5.00 score on a scale | Standard Deviation 0 |
| Adapted TranS-C (Immediate) | Provider-level Outcome: Acceptability Intervention Measure | Baseline | 4.74 score on a scale | Standard Deviation 0.41 |
| Adapted TranS-C (Immediate) | Provider-level Outcome: Acceptability Intervention Measure | Mid-treatment | 4.64 score on a scale | Standard Deviation 0.44 |
| Adapted TranS-C (Immediate) | Provider-level Outcome: Acceptability Intervention Measure | Post-treatment | 4.54 score on a scale | Standard Deviation 0.58 |
| Standard TranS-C (UC-DT) | Provider-level Outcome: Acceptability Intervention Measure | Post-treatment | 4.56 score on a scale | Standard Deviation 0.57 |
| Standard TranS-C (UC-DT) | Provider-level Outcome: Acceptability Intervention Measure | Mid-treatment | 4.65 score on a scale | Standard Deviation 0.44 |
| Standard TranS-C (UC-DT) | Provider-level Outcome: Acceptability Intervention Measure | Baseline | 4.76 score on a scale | Standard Deviation 0.39 |
Secondary
Patient-level Outcome: 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: Baseline, mid-treatment (2/4 weeks post-baseline), post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
Population: Mid-treatment and 6-month follow-up assessments were collected following TranS-C but were not collected following Usual Care (UC-DT). To increase the sample size, analyses comparing Standard vs. Adapted TranS-C collapsed over immediate and UC-DT conditions (using the assessments collected after the UC-DT group started TranS-C at mid-treatment, post-treatment, and 6-month follow-up). An additional analysis also collapsed across all conditions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard TranS-C (Immediate) | Patient-level Outcome: Composite Sleep Health Score | Mid-treatment | 3.50 score on a scale | Standard Deviation 2.12 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Composite Sleep Health Score | Baseline | 3.00 score on a scale | Standard Deviation 1.1 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Composite Sleep Health Score | 6-month follow-up | 4.00 score on a scale | Standard Deviation 1.41 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Composite Sleep Health Score | Post-treatment | 3.33 score on a scale | Standard Deviation 2.52 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Composite Sleep Health Score | 6-month follow-up | 2.94 score on a scale | Standard Deviation 1.62 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Composite Sleep Health Score | Mid-treatment | 3.28 score on a scale | Standard Deviation 1.54 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Composite Sleep Health Score | Post-treatment | 3.07 score on a scale | Standard Deviation 1.59 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Composite Sleep Health Score | Baseline | 2.25 score on a scale | Standard Deviation 1.29 |
| Standard TranS-C (UC-DT) | Patient-level Outcome: Composite Sleep Health Score | Post-treatment | 3.00 score on a scale | Standard Deviation 1.41 |
| Standard TranS-C (UC-DT) | Patient-level Outcome: Composite Sleep Health Score | Baseline | 2.29 score on a scale | Standard Deviation 1.5 |
| Adapted TranS-C (UC-DT) | Patient-level Outcome: Composite Sleep Health Score | Post-treatment | 2.66 score on a scale | Standard Deviation 1.45 |
| Adapted TranS-C (UC-DT) | Patient-level Outcome: Composite Sleep Health Score | Baseline | 2.45 score on a scale | Standard Deviation 1.47 |
| Immediate TranS-C | Patient-level Outcome: Composite Sleep Health Score | Mid-treatment | 3.29 score on a scale | Standard Deviation 1.54 |
| Immediate TranS-C | Patient-level Outcome: Composite Sleep Health Score | Post-treatment | 3.09 score on a scale | Standard Deviation 1.63 |
| Immediate TranS-C | Patient-level Outcome: Composite Sleep Health Score | Baseline | 2.31 score on a scale | Standard Deviation 1.28 |
| Immediate TranS-C | Patient-level Outcome: Composite Sleep Health Score | 6-month follow-up | 3.02 score on a scale | Standard Deviation 1.62 |
| UC-DT | Patient-level Outcome: Composite Sleep Health Score | Baseline | 2.43 score on a scale | Standard Deviation 1.46 |
| UC-DT | Patient-level Outcome: Composite Sleep Health Score | Post-treatment | 2.69 score on a scale | Standard Deviation 1.44 |
| Standard TranS-C | Patient-level Outcome: Composite Sleep Health Score | Baseline | 2.62 score on a scale | Standard Deviation 1.33 |
| Standard TranS-C | Patient-level Outcome: Composite Sleep Health Score | Mid-treatment | 3.50 score on a scale | Standard Deviation 1.73 |
| Standard TranS-C | Patient-level Outcome: Composite Sleep Health Score | Post-treatment | 2.50 score on a scale | Standard Deviation 2.07 |
| Standard TranS-C | Patient-level Outcome: Composite Sleep Health Score | 6-month follow-up | 3.57 score on a scale | Standard Deviation 1.62 |
| Adapted TranS-C | Patient-level Outcome: Composite Sleep Health Score | Post-treatment | 3.07 score on a scale | Standard Deviation 1.52 |
| Adapted TranS-C | Patient-level Outcome: Composite Sleep Health Score | Mid-treatment | 3.05 score on a scale | Standard Deviation 1.54 |
| Adapted TranS-C | Patient-level Outcome: Composite Sleep Health Score | 6-month follow-up | 2.90 score on a scale | Standard Deviation 1.52 |
| Adapted TranS-C | Patient-level Outcome: Composite Sleep Health Score | Baseline | 2.33 score on a scale | Standard Deviation 1.37 |
| TranS-C | Patient-level Outcome: Composite Sleep Health Score | 6-month follow-up | 2.95 score on a scale | Standard Deviation 1.53 |
| TranS-C | Patient-level Outcome: Composite Sleep Health Score | Baseline | 2.36 score on a scale | Standard Deviation 1.36 |
| TranS-C | Patient-level Outcome: Composite Sleep Health Score | Post-treatment | 3.03 score on a scale | Standard Deviation 1.56 |
| TranS-C | Patient-level Outcome: Composite Sleep Health Score | Mid-treatment | 3.08 score on a scale | Standard Deviation 1.55 |
Comparison: Appropriateness of intervention measure (IAM) predicting sleep health.p-value: 0.14Regression, Linear
Comparison: Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in Composite Sleep Health Score from pre to post.p-value: 0.09Intent-to-treat, multilevel modeling
Comparison: Standard TranS-C versus Adapted TranS-C on change in sleep health from pre to post.p-value: 0.11Intent-to-treat, multilevel modeling
Comparison: Acceptability of intervention measure (AIM) predicting sleep health.p-value: 0.59Regression, Linear
Comparison: Feasibility of intervention measure (FIM) predicting sleep health.p-value: 0.06Regression, Linear
Secondary
Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Impairment Scale. The 8-item short version scale assesses perceived sleep problems during waking hours (e.g., alertness, sleepiness, tiredness) over a 7-day period. Items are rated on a 5-point scale ranging from 1 (not at all) to 5 (very much). Raw scores are summed to produce a single score, resulting in a range from 8 to 40. Raw scores are converted to t-scores using treatment manuals. T-scores range from 30.1 to 80.1. A T-score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate worse sleep-related impairment.
Time frame: Baseline, mid-treatment (2/4 weeks post-baseline), post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
Population: Mid-treatment and 6-month follow-up assessments were collected following TranS-C but were not collected following Usual Care (UC-DT). To increase the sample size, analyses comparing Standard vs. Adapted TranS-C collapsed over immediate and UC-DT conditions (using the assessments collected post TranS-C for the UC-DT group). An additional analysis also collapsed across all conditions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Baseline | 63.12 T-score | Standard Deviation 10.63 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | 6-month follow-up | 50.75 T-score | Standard Deviation 9.05 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Post-treatment | 48.65 T-score | Standard Deviation 12.87 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Mid-treatment | 60.20 T-score | Standard Deviation 5.8 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Baseline | 60.30 T-score | Standard Deviation 8.57 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | 6-month follow-up | 53.82 T-score | Standard Deviation 11.29 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Mid-treatment | 55.67 T-score | Standard Deviation 10.66 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Post-treatment | 52.80 T-score | Standard Deviation 11.9 |
| Standard TranS-C (UC-DT) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Post-treatment | 59.66 T-score | Standard Deviation 6.61 |
| Standard TranS-C (UC-DT) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Baseline | 59.24 T-score | Standard Deviation 10.79 |
| Adapted TranS-C (UC-DT) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Baseline | 60.09 T-score | Standard Deviation 8.58 |
| Adapted TranS-C (UC-DT) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Post-treatment | 57.71 T-score | Standard Deviation 8.58 |
| Immediate TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Baseline | 60.59 T-score | Standard Deviation 8.76 |
| Immediate TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Mid-treatment | 55.89 T-score | Standard Deviation 10.47 |
| Immediate TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Post-treatment | 52.46 T-score | Standard Deviation 11.9 |
| Immediate TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | 6-month follow-up | 53.62 T-score | Standard Deviation 11.12 |
| UC-DT | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Baseline | 59.98 T-score | Standard Deviation 8.79 |
| UC-DT | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Post-treatment | 57.88 T-score | Standard Deviation 8.39 |
| Standard TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Mid-treatment | 55.83 T-score | Standard Deviation 8.82 |
| Standard TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Baseline | 61.18 T-score | Standard Deviation 10.54 |
| Standard TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | 6-month follow-up | 54.27 T-score | Standard Deviation 9.82 |
| Standard TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Post-treatment | 52.74 T-score | Standard Deviation 10.56 |
| Adapted TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Baseline | 60.20 T-score | Standard Deviation 8.54 |
| Adapted TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Mid-treatment | 56.76 T-score | Standard Deviation 10.45 |
| Adapted TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | 6-month follow-up | 54.71 T-score | Standard Deviation 10.9 |
| Adapted TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Post-treatment | 53.54 T-score | Standard Deviation 11.14 |
| TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | 6-month follow-up | 54.68 T-score | Standard Deviation 10.79 |
| TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Baseline | 60.31 T-score | Standard Deviation 8.75 |
| TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Mid-treatment | 56.70 T-score | Standard Deviation 10.3 |
| TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Post-treatment | 53.48 T-score | Standard Deviation 11.03 |
Comparison: Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in sleep- related impairment from pre to post.p-value: 0.001Intent-to-treat, multilevel modeling
Comparison: Standard TranS-C versus Adapted TranS-C on change in sleep-related impairment from pre to post.p-value: 0.72Intent-to-treat, multilevel modeling
Comparison: Acceptability of intervention measure (AIM) predicting sleep-related impairment.p-value: 0.3Regression, Linear
Comparison: Appropriateness of intervention measure (IAM) predicting sleep-related impairment.p-value: 0.78Regression, Linear
Comparison: Feasibility of intervention measure (FIM) predicting sleep-related impairment.p-value: 0.15Regression, Linear
Secondary
Patient-level Outcome: Sheehan Disability Scale
The Sheehan Disability Scale (SDS) assesses impairment in work/school, social, and family life. Items are rated on a scale from 0 (not at all) to 10 (extremely). Items are summed to produce a single score. Scores range from 0 to 30, with higher scores indicating higher functional impairment.
Time frame: Baseline, post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
Population: 6-month follow-up assessments were collected following TranS-C but were not collected following Usual Care (UC-DT). To increase the sample size, analyses comparing Standard vs. Adapted TranS-C collapsed over immediate and UC-DT conditions (using the assessments collected after the UC-DT group started TranS-C at post-treatment, and 6-month follow-up). An additional analysis also collapsed across all conditions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard TranS-C (Immediate) | Patient-level Outcome: Sheehan Disability Scale | Post-treatment | 6.50 score on a scale | Standard Deviation 6.35 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Sheehan Disability Scale | Baseline | 15.25 score on a scale | Standard Deviation 6.63 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Sheehan Disability Scale | 6-month follow-up | 9.75 score on a scale | Standard Deviation 8.26 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Sheehan Disability Scale | Post-treatment | 7.98 score on a scale | Standard Deviation 7.06 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Sheehan Disability Scale | Baseline | 12.49 score on a scale | Standard Deviation 7.72 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Sheehan Disability Scale | 6-month follow-up | 8.51 score on a scale | Standard Deviation 7.06 |
| Standard TranS-C (UC-DT) | Patient-level Outcome: Sheehan Disability Scale | Baseline | 11.75 score on a scale | Standard Deviation 10.07 |
| Standard TranS-C (UC-DT) | Patient-level Outcome: Sheehan Disability Scale | Post-treatment | 10.80 score on a scale | Standard Deviation 7.66 |
| Adapted TranS-C (UC-DT) | Patient-level Outcome: Sheehan Disability Scale | Post-treatment | 11.10 score on a scale | Standard Deviation 7.51 |
| Adapted TranS-C (UC-DT) | Patient-level Outcome: Sheehan Disability Scale | Baseline | 11.88 score on a scale | Standard Deviation 7.04 |
| Immediate TranS-C | Patient-level Outcome: Sheehan Disability Scale | Post-treatment | 7.86 score on a scale | Standard Deviation 6.95 |
| Immediate TranS-C | Patient-level Outcome: Sheehan Disability Scale | 6-month follow-up | 8.59 score on a scale | Standard Deviation 7.07 |
| Immediate TranS-C | Patient-level Outcome: Sheehan Disability Scale | Baseline | 12.77 score on a scale | Standard Deviation 7.62 |
| UC-DT | Patient-level Outcome: Sheehan Disability Scale | Baseline | 11.86 score on a scale | Standard Deviation 7.38 |
| UC-DT | Patient-level Outcome: Sheehan Disability Scale | Post-treatment | 11.07 score on a scale | Standard Deviation 7.46 |
| Standard TranS-C | Patient-level Outcome: Sheehan Disability Scale | Post-treatment | 8.86 score on a scale | Standard Deviation 7.73 |
| Standard TranS-C | Patient-level Outcome: Sheehan Disability Scale | 6-month follow-up | 9.71 score on a scale | Standard Deviation 8.46 |
| Standard TranS-C | Patient-level Outcome: Sheehan Disability Scale | Baseline | 13.50 score on a scale | Standard Deviation 8.43 |
| Adapted TranS-C | Patient-level Outcome: Sheehan Disability Scale | Post-treatment | 8.36 score on a scale | Standard Deviation 6.47 |
| Adapted TranS-C | Patient-level Outcome: Sheehan Disability Scale | Baseline | 12.21 score on a scale | Standard Deviation 7.4 |
| Adapted TranS-C | Patient-level Outcome: Sheehan Disability Scale | 6-month follow-up | 8.70 score on a scale | Standard Deviation 7.05 |
| TranS-C | Patient-level Outcome: Sheehan Disability Scale | Baseline | 12.36 score on a scale | Standard Deviation 7.5 |
| TranS-C | Patient-level Outcome: Sheehan Disability Scale | 6-month follow-up | 8.77 score on a scale | Standard Deviation 7.11 |
| TranS-C | Patient-level Outcome: Sheehan Disability Scale | Post-treatment | 8.40 score on a scale | Standard Deviation 6.54 |
Comparison: Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in functional impairment from pre to post.p-value: 0.002Intent-to-treat, multilevel modeling
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and functional impairment (Sheehan Disability Scale) at post was mediated by sleep disturbance (PROMIS-SD) at post. The parameter of interest was the indirect effect.p-value: 0.00295% CI: [-3.57, -0.83]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and functional impairment (Sheehan Disability Scale) at post was mediated by sleep-related impairment (PROMIS-SRI). The parameter of interest was the indirect effect at postp-value: 0.00195% CI: [-4.44, -1.08]SEM
Comparison: Standard TranS-C versus Adapted TranS-C on change in functional impairment from pre to post.p-value: 0.78Intent-to-treat, multilevel modeling
Comparison: Acceptability of intervention measure (AIM) predicting functional impairment.p-value: 0.49Regression, Linear
Comparison: Appropriateness of intervention measure (IAM) predicting functional impairment.p-value: 0.27Regression, Linear
Comparison: Feasibility of intervention measure (FIM) predicting functional impairment.p-value: 0.09Regression, Linear
Secondary
Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure
The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure (DSM-5) assesses psychiatric symptoms across 13 mental health domains. Participants rate on a 5-point scale how often they were bothered by each symptom on a scale from 0 (not at all) to 4 (nearly every day). Scores range from 0 to 52, with higher scores indicating more severe symptoms.
Time frame: Baseline, post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
Population: 6-month follow-up assessments were collected following TranS-C but were not collected following Usual Care (UC-DT). To increase the sample size, analyses comparing Standard vs. Adapted TranS-C collapsed over immediate and UC-DT conditions (using the assessments collected after the UC-DT group started TranS-C at mid-treatment, post-treatment, and 6-month follow-up). An additional analysis also collapsed across all conditions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard TranS-C (Immediate) | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | 6-month follow-up | 14.25 score on a scale | Standard Deviation 8.3 |
| Standard TranS-C (Immediate) | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Baseline | 25.38 score on a scale | Standard Deviation 8.93 |
| Standard TranS-C (Immediate) | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Post-treatment | 14.00 score on a scale | Standard Deviation 10.68 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Post-treatment | 17.91 score on a scale | Standard Deviation 9.61 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Baseline | 23.48 score on a scale | Standard Deviation 8.7 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | 6-month follow-up | 18.47 score on a scale | Standard Deviation 10.16 |
| Standard TranS-C (UC-DT) | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Baseline | 18.75 score on a scale | Standard Deviation 5.18 |
| Standard TranS-C (UC-DT) | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Post-treatment | 20.60 score on a scale | Standard Deviation 5.32 |
| Adapted TranS-C (UC-DT) | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Baseline | 23.25 score on a scale | Standard Deviation 9.48 |
| Adapted TranS-C (UC-DT) | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Post-treatment | 20.67 score on a scale | Standard Deviation 8.74 |
| Immediate TranS-C | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Baseline | 22.69 score on a scale | Standard Deviation 9.15 |
| Immediate TranS-C | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Post-treatment | 17.59 score on a scale | Standard Deviation 9.64 |
| Immediate TranS-C | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | 6-month follow-up | 18.19 score on a scale | Standard Deviation 10.04 |
| UC-DT | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Baseline | 23.68 score on a scale | Standard Deviation 8.69 |
| UC-DT | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Post-treatment | 20.67 score on a scale | Standard Deviation 8.46 |
| Standard TranS-C | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Baseline | 22.06 score on a scale | Standard Deviation 7.84 |
| Standard TranS-C | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Post-treatment | 16.14 score on a scale | Standard Deviation 8.07 |
| Standard TranS-C | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | 6-month follow-up | 17.29 score on a scale | Standard Deviation 7.2 |
| Adapted TranS-C | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Post-treatment | 18.00 score on a scale | Standard Deviation 9.34 |
| Adapted TranS-C | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | 6-month follow-up | 18.24 score on a scale | Standard Deviation 9.51 |
| Adapted TranS-C | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Baseline | 23.37 score on a scale | Standard Deviation 9.03 |
| TranS-C | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Post-treatment | 17.84 score on a scale | Standard Deviation 9.2 |
| TranS-C | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | 6-month follow-up | 18.18 score on a scale | Standard Deviation 9.34 |
| TranS-C | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Baseline | 23.23 score on a scale | Standard Deviation 8.89 |
Comparison: Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in psychiatric symptoms from pre to post.p-value: 0.002Intent-to-treat, multilevel modeling
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and psychiatric symptoms (Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by sleep disturbance (PROMIS-SD) at post. The parameter of interest was the indirect effect.p-value: 0.0295% CI: [-3.54, -0.36]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and psychiatric symptoms (Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by sleep-related impairment (PROMIS-SRI) at post. The parameter of interest was the indirect effect.p-value: 0.0195% CI: [-2.87, -0.38]SEM
Comparison: Standard TranS-C versus Adapted TranS-C on change in psychiatric symptoms from pre to post.p-value: 0.56Intent-to-treat, multilevel modeling
Comparison: Acceptability of intervention measure (AIM) predicting psychiatric symptoms.p-value: 0.34Regression, Linear
Comparison: Appropriateness of intervention measure (IAM) predicting psychiatric symptoms.p-value: 0.01Regression, Linear
Comparison: Feasibility of intervention measure (FIM) predicting psychiatric symptoms.p-value: 0.01Regression, Linear
Secondary
Provider-level Outcome: Feasibility of Intervention Measure
Assesses provider perceptions of the feasibility of the treatment intervention using a self-report questionnaire. The 4- item scale is rated on a 5-point scale from 1 (completely disagree) to 5 (completely agree). A total score is calculated by averaging all four items. Total scores range from 1 to 5, with higher scores indicating greater perceptions of feasibility.
Time frame: Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS-C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C).
Population: Feasibility of Intervention Measure was collected only from providers. To increase the sample size, and because providers treated patients who could have been in either the immediate or UC-DT conditions, we analyzed by collapsing across immediate and UC-DT for providers. For some analyses, data were collapsed across Standard and Adapted TranS-C. This measure was not assessed following usual care.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard TranS-C (Immediate) | Provider-level Outcome: Feasibility of Intervention Measure | Mid-treatment | 4.83 score on a scale | Standard Deviation 0.29 |
| Standard TranS-C (Immediate) | Provider-level Outcome: Feasibility of Intervention Measure | Baseline | 4.95 score on a scale | Standard Deviation 0.11 |
| Standard TranS-C (Immediate) | Provider-level Outcome: Feasibility of Intervention Measure | Post-treatment | 4.44 score on a scale | Standard Deviation 0.72 |
| Adapted TranS-C (Immediate) | Provider-level Outcome: Feasibility of Intervention Measure | Mid-treatment | 4.60 score on a scale | Standard Deviation 0.54 |
| Adapted TranS-C (Immediate) | Provider-level Outcome: Feasibility of Intervention Measure | Baseline | 4.59 score on a scale | Standard Deviation 0.57 |
| Adapted TranS-C (Immediate) | Provider-level Outcome: Feasibility of Intervention Measure | Post-treatment | 4.42 score on a scale | Standard Deviation 0.65 |
| Standard TranS-C (UC-DT) | Provider-level Outcome: Feasibility of Intervention Measure | Baseline | 4.64 score on a scale | Standard Deviation 0.54 |
| Standard TranS-C (UC-DT) | Provider-level Outcome: Feasibility of Intervention Measure | Post-treatment | 4.43 score on a scale | Standard Deviation 0.65 |
| Standard TranS-C (UC-DT) | Provider-level Outcome: Feasibility of Intervention Measure | Mid-treatment | 4.61 score on a scale | Standard Deviation 0.53 |
Secondary
Provider-level Outcome: Intervention Appropriateness Measure
Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire. The 4-item scale is rated on a 5-point scale from 1 (completely disagree) to 5 (completely agree). A total score is calculated by averaging all four items. Total scores range from 1 to 5, with higher scores indicating greater perceptions of appropriateness.
Time frame: Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS- C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C).
Population: Intervention Appropriateness Measure was collected only from providers. To increase the sample size, and because providers treated patients who could have been in either the immediate or UC-DT conditions, we analyzed by collapsing across immediate and UC-DT for providers. For some analyses, data were collapsed across Standard and Adapted TranS-C. This measure was not assessed following usual care.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard TranS-C (Immediate) | Provider-level Outcome: Intervention Appropriateness Measure | Mid-treatment | 4.83 score on a scale | Standard Deviation 0.29 |
| Standard TranS-C (Immediate) | Provider-level Outcome: Intervention Appropriateness Measure | Baseline | 5.00 score on a scale | Standard Deviation 0 |
| Standard TranS-C (Immediate) | Provider-level Outcome: Intervention Appropriateness Measure | Post-treatment | 4.75 score on a scale | Standard Deviation 0.5 |
| Adapted TranS-C (Immediate) | Provider-level Outcome: Intervention Appropriateness Measure | Mid-treatment | 4.56 score on a scale | Standard Deviation 0.52 |
| Adapted TranS-C (Immediate) | Provider-level Outcome: Intervention Appropriateness Measure | Baseline | 4.79 score on a scale | Standard Deviation 0.35 |
| Adapted TranS-C (Immediate) | Provider-level Outcome: Intervention Appropriateness Measure | Post-treatment | 4.39 score on a scale | Standard Deviation 0.67 |
| Standard TranS-C (UC-DT) | Provider-level Outcome: Intervention Appropriateness Measure | Baseline | 4.82 score on a scale | Standard Deviation 0.33 |
| Standard TranS-C (UC-DT) | Provider-level Outcome: Intervention Appropriateness Measure | Post-treatment | 4.41 score on a scale | Standard Deviation 0.67 |
| Standard TranS-C (UC-DT) | Provider-level Outcome: Intervention Appropriateness Measure | Mid-treatment | 4.58 score on a scale | Standard Deviation 0.51 |
Other Pre-specified
Facilitator-level Outcome: Implementation Log
Weekly record of facilitator activities, amount of time per activity, county, year, type of communication, implementation strategies, target(s), intended outcome(s).
Time frame: Up to 30 months
Other Pre-specified
Facilitator-level Outcome: Meeting Log
Weekly record of community meeting details as applicable, including: county, generation, level of contact (i.e., leadership, providers), type/modality of contact, length of meeting, number of attendees, recording, general description, standardized description, main presenter and role of UC Berkeley staff.
Time frame: Up to 30 months
Other Pre-specified
Patient-level Outcome: Alcohol Intake
Assesses past 30-day quantity and frequency of alcohol intake using a self-report questionnaire.
Time frame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Other Pre-specified
Patient-level Outcome: Caffeine Intake
Assesses past 30-day quantity and frequency of caffeine intake using a self-report questionnaire.
Time frame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Other Pre-specified
Patient-level Outcome: Credibility Expectancy Questionnaire
Measures the credibility and expectation of improvement from TranS-C. The questionnaire includes 4 items.
Time frame: Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment.
Other Pre-specified
Patient-level Outcome: Duke Checklist of Medical Conditions & Symptoms
Assesses physical illness or neurological degenerative disease directly related to the onset and course of the sleep and circadian dysfunction.
Time frame: Once at baseline.
Other Pre-specified
Patient-level Outcome: Midpoint of Sleep Measure
Assesses circadian functioning by calculating the midpoint between falling asleep time and rise time.
Time frame: Change from baseline, to mid-treatment, which is 2 or 4 weeks after the beginning of treatment, to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Other Pre-specified
Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
Assesses perceived functional impairments related to sleep problems using a self-report questionnaire. The minimum value is 8. The maximum value is 40. Higher scores mean more sleep disturbance (worse outcome).
Time frame: Change from baseline to mid-treatment, which is 2 or 4 weeks after the beginning of treatment
Other Pre-specified
Patient-level Outcome: Substances Intake
Assesses past 30-day frequency of substance use using a self-report questionnaire.
Time frame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Other Pre-specified
Patient-level Outcome: Suicidal Ideation Questionnaire
Assesses past 30-day suicidal ideation using a self-report questionnaire.
Time frame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Other Pre-specified
Patient-level Outcome: Tobacco Intake
Assesses past 30-day quantity and frequency of tobacco intake using a self-report questionnaire.
Time frame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Other Pre-specified
Patient-level Outcome: Utilization Questionnaire
Measures the elements of TranS-C that are most used.
Time frame: Once at 6-month follow-up after treatment ends.
Other Pre-specified
Patient-level Outcome: Utilization Questionnaire
Measures the elements of TranS-C that are most used.
Time frame: Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment.
Other Pre-specified
Provider-level Outcome: Acceptability Intervention Measure
Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire and provider feedback.
Time frame: Change from baseline to mid-treatment, which is 2 or 4 weeks after the beginning of treatment for each client
Other Pre-specified
Provider-level Outcome: Adaptations to Evidence-Based Practices Scale
Assesses ad hoc modifications the provider made to the treatment using a self-report questionnaire.
Time frame: Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment.
Other Pre-specified
Provider-level Outcome: Checklist of Modules Delivered
Assesses which treatment modules were delivered by the providers using a self-report checklist.
Time frame: Once at each session between patient and provider.
Other Pre-specified
Provider-level Outcome: Gold Standard Training Elements
Extent of gold standard training elements present in each training session, with respect to content and technique.
Time frame: Through the first 2.5 years of the study, an average of 4 per month
Other Pre-specified
Provider-level Outcome: Number of TranS-C Sessions
Number of sessions delivered to each enrolled patient by each provider.
Time frame: Once per patient at posttreatment, which is 6 or 10 weeks after the beginning of treatment
Other Pre-specified
Provider-level Outcome: Session Attendance and Duration Log
Collect session date and duration (length of session).
Time frame: Once at each session between patient and provider.
Other Pre-specified
Provider-level Outcome: Training Evaluation/Knowledge Test
Provider evaluation of the training; provider knowledge of content covered in the training; provider willingness and confidence in delivering TranS-C.
Time frame: Through the first 2.5 years of the study, an average of 4 per month
Other Pre-specified
Provider-level Outcome: Use of TranS-C Assessment
Assesses if providers continue to use TranS-C in a self-report questionnaire.
Time frame: Once during the 1 year sustainment phase.