Circadian Dysregulation, Sleep Disorder
Conditions
Brief summary
The sleep disturbance commonly experienced by individuals with a severe mental illness (SMI) reduces these individuals' capacity to function and contributes to key symptoms. This study will test the effects of a sleep treatment that has been adapted using theory, data and stakeholder inputs to improve the fit for SMI patients treated in community mental health centers (CMHCs), relative to the standard treatment. The investigators will also determine if the adapted and standard versions can improve sleep, improve functioning and reduce symptoms.
Detailed description
An obstacle to the roll-out of evidence-based psychological treatments (EBPTs) for severe mental illness (SMI) is that the context for the implementation typically differs from the original testing context causing a lack of fit between the setting and the EBPT. The investigators propose to evaluate if adapting a specific treatment to improve the contextual fit improves outcomes in a setting that typifies this challenge-community mental health centers (CMHCs). Following the Experimental Therapeutics Approach, the target is sleep and circadian dysfunction. In SMI, sleep and circadian dysfunction undermines affect regulation, cognitive function and physical health, predicts the 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. Hence, the investigators developed the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to treat a wide range of sleep and circadian problems experienced in SMI. With NIMH support, including a study in CMHCs, the investigators established that TranS-C engages the target. Yet gaps remain: 1) Thus far, the TranS-C providers have been employed, trained and supervised by the university. The investigators will determine if TranS-C can be effectively delivered by providers within CMHCs. 2) The investigators will test a version of TranS-C that has been adapted to improve the fit and to address potential barriers to scaling TranS-C. The rigorous adaptation process used theory, data and stakeholder inputs. 3) The investigators will study ad hoc adaptations made by providers to TranS-C. 4) The investigators include a Sustainment Phase (1 year), responding to urgent calls to study the sustainability of EBPTs. This entry describes the Implementation Phase, the first of a three-phase hybrid type 2 effectiveness-implementation trial. In this phase, implementation and effectiveness outcomes of two versions of TranS-C (Standard and Adapted) are compared with CMHC providers who are trained by treatment experts. Guided by the Replicating Effective Programs (REP) framework, at least 8 CMHC clinic sites will be cluster randomized to either Standard or Adapted TranS-C. Then, within each CMHC site, patients will be randomized to immediate TranS-C or to Usual Care followed by Delayed Treatment (UC-DT). A total of 96 providers and 576 patients. Patients will be assessed pre, mid and post-treatment and at 6 months follow-up. UC Berkeley will co-ordinate the research, facilitate implementation, collect data etc. Providers within an established network of CMHCs will implement TranS-C. 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. SA2 is to evaluate the fit, to the CMHC context, of Standard vs. Adapted TranS-C via provider ratings of acceptability, appropriateness and feasibility. SA3 will examine if better fit, operationalized via provider ratings of acceptability, mediates the relationship between treatment condition and patient outcome. This research will determine if sleep and circadian problems can be effectively addressed in SMI in CMHC settings, 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 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 Disturbance | 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), 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 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C), 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 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C), 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 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), 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 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), 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: Semi-structured Interview | 20% of randomly selected providers and leadership once during the implementation phase and once during the sustainment phase. | Assesses perceptions of TranS-C. |
| 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). |
| 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: 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. |
| 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: Gold Standard Supervision Elements | Up to 30 months | Presence of gold-standard supervision elements covered during each supervision session. |
| 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 University of California, Berkeley staff. |
| 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: 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
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. | 74 |
| 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. | 124 |
| 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. | 71 |
| 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. | 127 |
| Standard TranS-C (Immediate) - 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. | 30 |
| Adapted TranS-C (Immediate) - 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. | 63 |
| Total | 489 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Patients lost to post or 6-month follow-up | 42 | 53 |
Baseline characteristics
| Characteristic | Adapted TranS-C (Immediate) - Providers | Adapted TranS-C (Immediate) | Standard TranS-C (UC-DT) | Adapted TranS-C (UC-DT) | Total | Standard TranS-C (Immediate) | Standard TranS-C (Immediate) - Providers |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 41.54 years STANDARD_DEVIATION 11.38 | 42.42 years STANDARD_DEVIATION 16.36 | 45.21 years STANDARD_DEVIATION 16.88 | 42.90 years STANDARD_DEVIATION 15.39 | 40.51 years STANDARD_DEVIATION 11.02 | 38.84 years STANDARD_DEVIATION 13.56 | 38.26 years STANDARD_DEVIATION 10.06 |
| Annual Household Income <$10,000 | — | 23 Participants | 9 Participants | 30 Participants | 72 Participants | 10 Participants | — |
| Annual Household Income $10,000-$20,000 | — | 31 Participants | 19 Participants | 21 Participants | 87 Participants | 16 Participants | — |
| Annual Household Income $20,000-$30,000 | — | 10 Participants | 2 Participants | 15 Participants | 38 Participants | 11 Participants | — |
| Annual Household Income $30,00-$40,000 | — | 6 Participants | 5 Participants | 9 Participants | 24 Participants | 4 Participants | — |
| Annual Household Income $40,000-$50,000 | — | 6 Participants | 2 Participants | 3 Participants | 13 Participants | 2 Participants | — |
| Annual Household Income >= $50,000 | — | 18 Participants | 11 Participants | 17 Participants | 52 Participants | 6 Participants | — |
| Annual Household Income I don't know my income | — | 28 Participants | 23 Participants | 29 Participants | 104 Participants | 24 Participants | — |
| Annual Household Income Missing/declined to answer | — | 2 Participants | 0 Participants | 3 Participants | 6 Participants | 1 Participants | — |
| Caseload | 29.59 number of patients STANDARD_DEVIATION 31.62 | — | — | — | 33.31 number of patients STANDARD_DEVIATION 29.37 | — | 40.09 number of patients STANDARD_DEVIATION 23.97 |
| Civil Status Missing/declined to answer | — | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | — |
| Civil Status Other/category not listed | — | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants | — |
| Civil Status Partnered | — | 19 Participants | 14 Participants | 19 Participants | 64 Participants | 12 Participants | — |
| Civil Status Unpartnered | — | 105 Participants | 57 Participants | 106 Participants | 328 Participants | 60 Participants | — |
| Degree Type Marriage and Family Therapy | 13 Participants | — | — | — | 23 Participants | — | 10 Participants |
| Degree Type Medical | 0 Participants | — | — | — | 1 Participants | — | 1 Participants |
| Degree Type Missing/declined to answer | 12 Participants | — | — | — | 16 Participants | — | 4 Participants |
| Degree Type Nursing | 1 Participants | — | — | — | 1 Participants | — | 0 Participants |
| Degree Type Occupational Therapy | 5 Participants | — | — | — | 5 Participants | — | 0 Participants |
| Degree Type Other/category not listed | 5 Participants | — | — | — | 9 Participants | — | 4 Participants |
| Degree Type Psychology | 7 Participants | — | — | — | 10 Participants | — | 3 Participants |
| Degree Type Social Work | 20 Participants | — | — | — | 28 Participants | — | 8 Participants |
| Education High school graduate or below | — | 40 Participants | 23 Participants | 34 Participants | 118 Participants | 21 Participants | — |
| Education Missing/declined to answer | — | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 2 Participants | — |
| Education Other/category not listed | — | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | — |
| Education Some or completed college or vocational school | — | 73 Participants | 43 Participants | 80 Participants | 246 Participants | 50 Participants | — |
| Education Some or completed graduate school | — | 10 Participants | 4 Participants | 13 Participants | 28 Participants | 1 Participants | — |
| Education | — | 13.87 years STANDARD_DEVIATION 3.35 | 13.36 years STANDARD_DEVIATION 2.96 | 14.97 years STANDARD_DEVIATION 3.72 | 14.08 years STANDARD_DEVIATION 3.37 | 13.59 years STANDARD_DEVIATION 2.87 | — |
| Employment Full-time | — | 16 Participants | 13 Participants | 19 Participants | 59 Participants | 11 Participants | — |
| Employment Missing/declined to answer | — | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | — |
| Employment Not employed | — | 78 Participants | 45 Participants | 81 Participants | 250 Participants | 46 Participants | — |
| Employment Other/category not listed | — | 4 Participants | 3 Participants | 10 Participants | 20 Participants | 3 Participants | — |
| Employment Part-time | — | 26 Participants | 10 Participants | 17 Participants | 65 Participants | 12 Participants | — |
| Employment Duration | 3.84 years STANDARD_DEVIATION 3.96 | — | — | — | 3.85 years STANDARD_DEVIATION 3.78 | — | 3.87 years STANDARD_DEVIATION 9.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants | 44 Participants | 29 Participants | 46 Participants | 167 Participants | 22 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 79 Participants | 40 Participants | 80 Participants | 298 Participants | 51 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants | 1 Participants | 2 Participants | 1 Participants | 24 Participants | 1 Participants | 6 Participants |
| Government Assistance Food Stamps | — | 34 Participants | 22 Participants | 34 Participants | 115 Participants | 25 Participants | — |
| Government Assistance Medicaid | — | 41 Participants | 14 Participants | 46 Participants | 129 Participants | 28 Participants | — |
| Government Assistance Medicare | — | 22 Participants | 12 Participants | 20 Participants | 61 Participants | 7 Participants | — |
| Government Assistance Missing/declined to answer | — | 29 Participants | 17 Participants | 21 Participants | 87 Participants | 20 Participants | — |
| Government Assistance None | — | 4 Participants | 1 Participants | 1 Participants | 6 Participants | 0 Participants | — |
| Government Assistance Other/category not listed | — | 21 Participants | 8 Participants | 30 Participants | 66 Participants | 7 Participants | — |
| Government Assistance Social Security | — | 22 Participants | 10 Participants | 15 Participants | 55 Participants | 8 Participants | — |
| Government Assistance Supplemental Nutrition Assistance Program | — | 4 Participants | 3 Participants | 14 Participants | 23 Participants | 2 Participants | — |
| Government Assistance Supplemental Security Income/Social Security Disability Insurance | — | 32 Participants | 17 Participants | 27 Participants | 85 Participants | 9 Participants | — |
| Government Assistance Unemployment | — | 4 Participants | 2 Participants | 9 Participants | 21 Participants | 6 Participants | — |
| Licensure Licensed | 32 Participants | — | — | — | 48 Participants | — | 16 Participants |
| Licensure Missing/declined to answer | 11 Participants | — | — | — | 14 Participants | — | 3 Participants |
| Licensure Not Licensed | 20 Participants | — | — | — | 31 Participants | — | 11 Participants |
| Living Arrangement Alone | — | 31 Participants | 15 Participants | 23 Participants | 78 Participants | 9 Participants | — |
| Living Arrangement Missing/declined to answer | — | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | — |
| Living Arrangement Other/category not listed | — | 4 Participants | 1 Participants | 5 Participants | 12 Participants | 2 Participants | — |
| Living Arrangement Supportive housing | — | 6 Participants | 1 Participants | 11 Participants | 20 Participants | 2 Participants | — |
| Living Arrangement With family | — | 66 Participants | 39 Participants | 66 Participants | 220 Participants | 49 Participants | — |
| Living Arrangement With friend or roommate or With friend or roommate or pet | — | 17 Participants | 15 Participants | 21 Participants | 64 Participants | 11 Participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 13 Participants | 5 Participants | 13 Participants | 42 Participants | 9 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 7 Participants | 8 Participants | 14 Participants | 46 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 13 Participants | 5 Participants | 14 Participants | 40 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 6 Participants | 3 Participants | 12 Participants | 31 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 10 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 15 Participants | 9 Participants | 11 Participants | 60 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) White | 32 Participants | 68 Participants | 39 Participants | 62 Participants | 260 Participants | 40 Participants | 19 Participants |
| Region of Enrollment United States | 63 Participants | 124 Participants | 71 Participants | 127 Participants | 489 Participants | 74 Participants | 30 Participants |
| Self-reported Diagnosis Anxiety disorders | — | 73 Participants | 42 Participants | 66 Participants | 219 Participants | 38 Participants | — |
| Self-reported Diagnosis Bipolar Disorder | — | 29 Participants | 9 Participants | 33 Participants | 93 Participants | 22 Participants | — |
| Self-reported Diagnosis Dissociative disorders | — | 3 Participants | 2 Participants | 0 Participants | 6 Participants | 1 Participants | — |
| Self-reported Diagnosis Feeding and eating disorders | — | 2 Participants | 0 Participants | 0 Participants | 4 Participants | 2 Participants | — |
| Self-reported Diagnosis Major Depressive Disorder | — | 54 Participants | 37 Participants | 51 Participants | 185 Participants | 43 Participants | — |
| Self-reported Diagnosis Missing/declined to answer | — | 9 Participants | 7 Participants | 10 Participants | 27 Participants | 1 Participants | — |
| Self-reported Diagnosis Neurodevelopmental disorders | — | 9 Participants | 8 Participants | 11 Participants | 36 Participants | 8 Participants | — |
| Self-reported Diagnosis Obsessive-compulsive and related disorders | — | 6 Participants | 4 Participants | 4 Participants | 16 Participants | 2 Participants | — |
| Self-reported Diagnosis Other/category not listed | — | 3 Participants | 1 Participants | 3 Participants | 9 Participants | 2 Participants | — |
| Self-reported Diagnosis Personality disorders | — | 3 Participants | 1 Participants | 7 Participants | 14 Participants | 3 Participants | — |
| Self-reported Diagnosis Psychosis | — | 40 Participants | 22 Participants | 45 Participants | 130 Participants | 23 Participants | — |
| Self-reported Diagnosis Substance-related and addictive disorders | — | 1 Participants | 2 Participants | 1 Participants | 6 Participants | 2 Participants | — |
| Self-reported Diagnosis Trauma and stressor-related disorders | — | 34 Participants | 14 Participants | 36 Participants | 107 Participants | 23 Participants | — |
| Sex/Gender, Customized Female | 47 Participants | 83 Participants | 43 Participants | 74 Participants | 312 Participants | 42 Participants | 23 Participants |
| Sex/Gender, Customized Male | 5 Participants | 41 Participants | 27 Participants | 52 Participants | 161 Participants | 31 Participants | 5 Participants |
| Sex/Gender, Customized Missing/declined to answer | 10 Participants | 0 Participants | 1 Participants | 1 Participants | 15 Participants | 1 Participants | 2 Participants |
| Sex/Gender, Customized Other/category not listed | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Therapeutic Approach Client Centered | 40 Participants | — | — | — | 59 Participants | — | 19 Participants |
| Therapeutic Approach Cognitive Behavioral Therapy | 30 Participants | — | — | — | 51 Participants | — | 21 Participants |
| Therapeutic Approach Family Systems | 15 Participants | — | — | — | 20 Participants | — | 5 Participants |
| Therapeutic Approach Humanistic | 0 Participants | — | — | — | 2 Participants | — | 2 Participants |
| Therapeutic Approach Integrative/Holistic | 3 Participants | — | — | — | 4 Participants | — | 1 Participants |
| Therapeutic Approach Missing/declined to answer | 13 Participants | — | — | — | 16 Participants | — | 3 Participants |
| Therapeutic Approach None | 3 Participants | — | — | — | 3 Participants | — | 0 Participants |
| Therapeutic Approach Psychodynamic | 11 Participants | — | — | — | 18 Participants | — | 7 Participants |
| Years Since Degree Earned | 9.62 years STANDARD_DEVIATION 7.4 | — | — | — | 9.56 years STANDARD_DEVIATION 7.43 | — | 9.44 years STANDARD_DEVIATION 7.66 |
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 / 74 | 0 / 124 | 0 / 71 | 0 / 127 | 0 / 30 | 0 / 63 |
| other Total, other adverse events | 0 / 74 | 0 / 124 | 0 / 71 | 0 / 127 | 0 / 30 | 0 / 63 |
| serious Total, serious adverse events | 0 / 74 | 0 / 124 | 0 / 71 | 0 / 127 | 0 / 30 | 0 / 63 |
Outcome results
Primary
Patient-level Outcome: Patient-Reported Outcomes Measurement 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 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), 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance | Post-treatment | 52.31 T-score | Standard Error 10.22 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance | Baseline | 63.86 T-score | Standard Error 7.04 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance | 6-month follow-up | 54.65 T-score | Standard Error 9.59 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance | Mid-treatment | 53.60 T-score | Standard Error 9.21 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance | Mid-treatment | 54.00 T-score | Standard Error 8.72 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance | Baseline | 62.10 T-score | Standard Error 7.17 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance | 6-month follow-up | 53.87 T-score | Standard Error 11.03 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance | Post-treatment | 50.36 T-score | Standard Error 10.04 |
| Standard TranS-C (UC-DT) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance | Post-treatment | 60.91 T-score | Standard Error 8.5 |
| Standard TranS-C (UC-DT) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance | Baseline | 62.81 T-score | Standard Error 7.36 |
| Adapted TranS-C (UC-DT) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance | Post-treatment | 62.11 T-score | Standard Error 8.23 |
| Adapted TranS-C (UC-DT) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance | Baseline | 62.80 T-score | Standard Error 8.2 |
| Immediate TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance | Mid-treatment | 53.87 T-score | Standard Error 8.84 |
| Immediate TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance | 6-month follow-up | 54.11 T-score | Standard Error 10.58 |
| Immediate TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance | Baseline | 62.76 T-score | Standard Error 7.15 |
| Immediate TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance | Post-treatment | 50.83 T-score | Standard Error 10.07 |
| UC-DT | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance | Baseline | 62.80 T-score | Standard Error 7.89 |
| UC-DT | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance | Post-treatment | 61.65 T-score | Standard Error 8.33 |
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
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.p-value: 0.9595% CI: [-4.62, 4.95]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.p-value: 0.9595% CI: [-2.39, 2.56]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.p-value: 0.8895% CI: [-2.31, 1.98]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.p-value: 0.8895% CI: [-3.1, 2.31]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.p-value: 0.7995% CI: [-2.18, 1.66]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.p-value: 0.7995% CI: [-2.18, 1.66]SEM
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. Provider perceptions of acceptability were analyzed only for providers who had treated at least one patient in the immediate TranS-C condition. Data from providers who had treated patients in the delayed TranS-C condition were not reported due to substantial overlap with those in the immediate group. As a result, we present Standard and Adapted data exclusively for the immediate TranS-C condition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard TranS-C (Immediate) | Provider-level Outcome: Acceptability Intervention Measure | Post-treatment | 4.64 score on a scale | Standard Deviation 0.63 |
| Standard TranS-C (Immediate) | Provider-level Outcome: Acceptability Intervention Measure | Baseline | 4.69 score on a scale | Standard Deviation 0.41 |
| Standard TranS-C (Immediate) | Provider-level Outcome: Acceptability Intervention Measure | Mid-treatment | 4.70 score on a scale | Standard Deviation 0.49 |
| Adapted TranS-C (Immediate) | Provider-level Outcome: Acceptability Intervention Measure | Baseline | 4.70 score on a scale | Standard Deviation 0.46 |
| Adapted TranS-C (Immediate) | Provider-level Outcome: Acceptability Intervention Measure | Mid-treatment | 4.60 score on a scale | Standard Deviation 0.49 |
| Adapted TranS-C (Immediate) | Provider-level Outcome: Acceptability Intervention Measure | Post-treatment | 4.67 score on a scale | Standard Deviation 0.53 |
Comparison: Treatment effect (Standard versus Adapted TranS-C) on change in Acceptability Intervention Measure (AIM) from baseline (post-training) to post-treatment.p-value: 0.77Intent-to-treat, multilevel modeling
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 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), 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard TranS-C (Immediate) | Patient-level Outcome: Composite Sleep Health Score | Baseline | 1.80 score on a scale | Standard Deviation 1.42 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Composite Sleep Health Score | Mid-treatment | 3.41 score on a scale | Standard Deviation 1.43 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Composite Sleep Health Score | Post-treatment | 3.76 score on a scale | Standard Deviation 1.59 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Composite Sleep Health Score | 6-month follow-up | 3.18 score on a scale | Standard Deviation 1.63 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Composite Sleep Health Score | Post-treatment | 3.47 score on a scale | Standard Deviation 1.55 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Composite Sleep Health Score | Baseline | 2.11 score on a scale | Standard Deviation 1.47 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Composite Sleep Health Score | Mid-treatment | 3.34 score on a scale | Standard Deviation 1.51 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Composite Sleep Health Score | 6-month follow-up | 3.36 score on a scale | Standard Deviation 1.51 |
| Standard TranS-C (UC-DT) | Patient-level Outcome: Composite Sleep Health Score | Baseline | 1.95 score on a scale | Standard Deviation 1.35 |
| Standard TranS-C (UC-DT) | Patient-level Outcome: Composite Sleep Health Score | Post-treatment | 2.05 score on a scale | Standard Deviation 1.49 |
| Adapted TranS-C (UC-DT) | Patient-level Outcome: Composite Sleep Health Score | Baseline | 2.14 score on a scale | Standard Deviation 1.33 |
| Adapted TranS-C (UC-DT) | Patient-level Outcome: Composite Sleep Health Score | Post-treatment | 2.33 score on a scale | Standard Deviation 1.48 |
| Immediate TranS-C | Patient-level Outcome: Composite Sleep Health Score | Baseline | 1.99 score on a scale | Standard Deviation 1.46 |
| Immediate TranS-C | Patient-level Outcome: Composite Sleep Health Score | Post-treatment | 3.54 score on a scale | Standard Deviation 1.55 |
| Immediate TranS-C | Patient-level Outcome: Composite Sleep Health Score | 6-month follow-up | 3.30 score on a scale | Standard Deviation 1.54 |
| Immediate TranS-C | Patient-level Outcome: Composite Sleep Health Score | Mid-treatment | 3.36 score on a scale | Standard Deviation 1.48 |
| UC-DT | Patient-level Outcome: Composite Sleep Health Score | Post-treatment | 2.22 score on a scale | Standard Deviation 1.49 |
| UC-DT | Patient-level Outcome: Composite Sleep Health Score | Baseline | 2.07 score on a scale | Standard Deviation 1.33 |
Comparison: Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in Composite Sleep Health Score from pre to post.p-value: <0.001Intent-to-treat, multilevel modeling
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 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), 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Baseline | 62.78 T-score | Standard Deviation 9.21 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Mid-treatment | 57.01 T-score | Standard Deviation 10.06 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Post-treatment | 54.21 T-score | Standard Deviation 9.45 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | 6-month follow-up | 57.40 T-score | Standard Deviation 10.57 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Post-treatment | 51.03 T-score | Standard Deviation 10.6 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Baseline | 61.62 T-score | Standard Deviation 8.59 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Mid-treatment | 55.05 T-score | Standard Deviation 10.62 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | 6-month follow-up | 53.88 T-score | Standard Deviation 11.68 |
| Standard TranS-C (UC-DT) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Baseline | 60.79 T-score | Standard Deviation 8.88 |
| Standard TranS-C (UC-DT) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Post-treatment | 60.27 T-score | Standard Deviation 8.11 |
| Adapted TranS-C (UC-DT) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Baseline | 62.69 T-score | Standard Deviation 7.53 |
| Adapted TranS-C (UC-DT) | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Post-treatment | 61.73 T-score | Standard Deviation 8.59 |
| Immediate TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Baseline | 62.06 T-score | Standard Deviation 8.82 |
| Immediate TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Post-treatment | 51.78 T-score | Standard Deviation 10.38 |
| Immediate TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | 6-month follow-up | 54.99 T-score | Standard Deviation 11.42 |
| Immediate TranS-C | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Mid-treatment | 55.69 T-score | Standard Deviation 10.43 |
| UC-DT | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Post-treatment | 61.17 T-score | Standard Deviation 8.42 |
| UC-DT | Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Baseline | 62.01 T-score | Standard Deviation 8.07 |
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: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.p-value: 0.9295% CI: [-5.04, 5.56]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.p-value: 0.9295% CI: [-2.04, 2.24]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.p-value: 0.7895% CI: [-3.1, 2.31]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.p-value: 0.7895% CI: [-2.35, 1.75]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.p-value: 0.8495% CI: [-4.66, 3.8]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.p-value: 0.8495% CI: [-1.94, 1.58]SEM
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 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C), 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard TranS-C (Immediate) | Patient-level Outcome: Sheehan Disability Scale | Baseline | 12.26 score on a scale | Standard Deviation 7.97 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Sheehan Disability Scale | Post-Treatment | 8.08 score on a scale | Standard Deviation 6.38 |
| Standard TranS-C (Immediate) | Patient-level Outcome: Sheehan Disability Scale | 6-month follow-up | 9.09 score on a scale | Standard Deviation 7.62 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Sheehan Disability Scale | Post-Treatment | 5.97 score on a scale | Standard Deviation 5.9 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Sheehan Disability Scale | Baseline | 12.85 score on a scale | Standard Deviation 7.04 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: Sheehan Disability Scale | 6-month follow-up | 8.78 score on a scale | Standard Deviation 7.85 |
| Standard TranS-C (UC-DT) | Patient-level Outcome: Sheehan Disability Scale | Baseline | 12.24 score on a scale | Standard Deviation 7.04 |
| Standard TranS-C (UC-DT) | Patient-level Outcome: Sheehan Disability Scale | Post-Treatment | 12.59 score on a scale | Standard Deviation 7.37 |
| Adapted TranS-C (UC-DT) | Patient-level Outcome: Sheehan Disability Scale | Baseline | 13.65 score on a scale | Standard Deviation 6.51 |
| Adapted TranS-C (UC-DT) | Patient-level Outcome: Sheehan Disability Scale | Post-Treatment | 12.19 score on a scale | Standard Deviation 7.08 |
| Immediate TranS-C | Patient-level Outcome: Sheehan Disability Scale | Baseline | 12.63 score on a scale | Standard Deviation 7.38 |
| Immediate TranS-C | Patient-level Outcome: Sheehan Disability Scale | Post-Treatment | 6.49 score on a scale | Standard Deviation 6.06 |
| Immediate TranS-C | Patient-level Outcome: Sheehan Disability Scale | 6-month follow-up | 8.88 score on a scale | Standard Deviation 7.75 |
| UC-DT | Patient-level Outcome: Sheehan Disability Scale | Baseline | 13.15 score on a scale | Standard Deviation 6.72 |
| UC-DT | Patient-level Outcome: Sheehan Disability Scale | Post-Treatment | 12.32 score on a scale | Standard Deviation 7.17 |
Comparison: Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in functional impairment from pre to post.p-value: <0.001Intent-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: <0.00195% CI: [-4.58, -1.66]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: [-5.41, -2.22]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.p-value: 0.9495% CI: [-1.78, 1.92]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.p-value: 0.9495% CI: [-1.16, 1.25]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.p-value: 0.8595% CI: [-0.3, 0.37]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.p-value: 0.795% CI: [-1.41, 0.95]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.p-value: 0.9295% CI: [-0.23, 0.25]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.p-value: 0.8295% CI: [-0.68, 0.54]SEM
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 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C), 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).
| 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 | 19.53 score on a scale | Standard Deviation 9.71 |
| Standard TranS-C (Immediate) | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Baseline | 24.58 score on a scale | Standard Deviation 8.47 |
| Standard TranS-C (Immediate) | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Post-treatment | 20.33 score on a scale | Standard Deviation 9.78 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Post-treatment | 18.44 score on a scale | Standard Deviation 10.88 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | 6-month follow-up | 19.33 score on a scale | Standard Deviation 10.09 |
| Adapted TranS-C (Immediate) | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Baseline | 24.12 score on a scale | Standard Deviation 9.29 |
| Standard TranS-C (UC-DT) | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Post-treatment | 22.90 score on a scale | Standard Deviation 10.19 |
| Standard TranS-C (UC-DT) | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Baseline | 24.31 score on a scale | Standard Deviation 10.33 |
| Adapted TranS-C (UC-DT) | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Post-treatment | 23.62 score on a scale | Standard Deviation 7.9 |
| Adapted TranS-C (UC-DT) | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Baseline | 24.11 score on a scale | Standard Deviation 8.93 |
| Immediate TranS-C | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | 6-month follow-up | 19.39 score on a scale | Standard Deviation 9.94 |
| Immediate TranS-C | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Baseline | 24.30 score on a scale | Standard Deviation 8.97 |
| Immediate TranS-C | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Post-treatment | 18.88 score on a scale | Standard Deviation 10.62 |
| UC-DT | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Post-treatment | 23.35 score on a scale | Standard Deviation 8.82 |
| UC-DT | Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure | Baseline | 24.18 score on a scale | Standard Deviation 9.43 |
Comparison: Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in psychiatric symptoms from pre to post.p-value: <0.001Intent-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: 0.0895% CI: [-3.93, -0.21]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: 0.0295% CI: [-4.58, -0.44]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.p-value: 0.9795% CI: [-1.99, 2.08]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.p-value: 0.9795% CI: [-0.18, 0.19]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.p-value: 0.995% CI: [-0.27, 0.3]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.p-value: 0.9495% CI: [-0.19, 0.2]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.p-value: 0.895% CI: [-1.67, 1.28]SEM
Comparison: Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.p-value: 0.7795% CI: [-0.33, 0.25]SEM
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. Provider perceptions of feasibility were analyzed only for providers who had treated at least one patient in the immediate TranS-C condition. Data from providers who had treated patients in the delayed TranS-C condition were not reported due to substantial overlap with those in the immediate group. As a result, we present Standard and Adapted data exclusively for the immediate TranS-C condition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard TranS-C (Immediate) | Provider-level Outcome: Feasibility of Intervention Measure | Baseline | 4.63 score on a scale | Standard Deviation 0.46 |
| Standard TranS-C (Immediate) | Provider-level Outcome: Feasibility of Intervention Measure | Mid-treatment | 4.64 score on a scale | Standard Deviation 0.59 |
| Standard TranS-C (Immediate) | Provider-level Outcome: Feasibility of Intervention Measure | Post-treatment | 4.61 score on a scale | Standard Deviation 0.74 |
| Adapted TranS-C (Immediate) | Provider-level Outcome: Feasibility of Intervention Measure | Baseline | 4.61 score on a scale | Standard Deviation 0.48 |
| Adapted TranS-C (Immediate) | Provider-level Outcome: Feasibility of Intervention Measure | Mid-treatment | 4.51 score on a scale | Standard Deviation 0.58 |
| Adapted TranS-C (Immediate) | Provider-level Outcome: Feasibility of Intervention Measure | Post-treatment | 4.61 score on a scale | Standard Deviation 0.52 |
Comparison: Treatment effect (Standard versus Adapted TranS-C) on change in Feasibility of Intervention Measure (FIM) from baseline (post-training) to post-treatment.p-value: 0.34Intent-to-treat, multilevel modeling
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.Provider perceptions of appropriateness were analyzed only for providers who had treated at least one patient in the immediate TranS-C condition. Data from providers who had treated patients in the delayed TranS-C condition were not reported due to substantial overlap with those in the immediate group. As a result, we present Standard and Adapted data exclusively for the immediate TranS-C condition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard TranS-C (Immediate) | Provider-level Outcome: Intervention Appropriateness Measure | Baseline | 4.62 score on a scale | Standard Deviation 0.5 |
| Standard TranS-C (Immediate) | Provider-level Outcome: Intervention Appropriateness Measure | Mid-treatment | 4.70 score on a scale | Standard Deviation 0.55 |
| Standard TranS-C (Immediate) | Provider-level Outcome: Intervention Appropriateness Measure | Post-treatment | 4.59 score on a scale | Standard Deviation 0.69 |
| Adapted TranS-C (Immediate) | Provider-level Outcome: Intervention Appropriateness Measure | Baseline | 4.69 score on a scale | Standard Deviation 0.46 |
| Adapted TranS-C (Immediate) | Provider-level Outcome: Intervention Appropriateness Measure | Mid-treatment | 4.47 score on a scale | Standard Deviation 0.57 |
| Adapted TranS-C (Immediate) | Provider-level Outcome: Intervention Appropriateness Measure | Post-treatment | 4.59 score on a scale | Standard Deviation 0.54 |
Comparison: Treatment effect (Standard versus Adapted TranS-C) on change in Intervention Appropriateness Measure (IAM) from baseline (post-training) to post-treatment.p-value: 0.94Intent-to-treat, multilevel modeling
Other Pre-specified
Facilitator-level Outcome: Gold Standard Supervision Elements
Presence of gold-standard supervision elements covered during each supervision session.
Time frame: Up to 30 months
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 University of California, 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: 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: 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: Semi-structured Interview
Assesses perceptions of TranS-C.
Time frame: 20% of randomly selected providers and leadership once during the implementation phase and once during the sustainment phase.
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.