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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard TranS-C | Experimental | 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. |
|
| Adapted TranS-C | Experimental | 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. |
|
| UC-DT | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-level Outcome: Midpoint of Sleep Measure | Assesses circadian functioning by calculating the midpoint between falling asleep time and rise time. | 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. |
Inclusion Criteria:
The inclusion criteria for CMHCs are:
The inclusion criteria for CMHC providers are:
Consumers must meet the following inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allison Harvey, PhD | University of California, Berkeley | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contra Costa Health, Housing, and Homeless Services Division | Concord | California | 94520 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41171520 | Derived | Diaz M, Milner AE, Sarfan LD, Agnew ER, Oliver SM, Bol K, Harvey AG. Do Provider Characteristics and Perceptions Influence the Adoption and Implementation of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TSC) in Community Mental Health Centers? Community Ment Health J. 2026 May;62(4):619-631. doi: 10.1007/s10597-025-01552-y. Epub 2025 Oct 31. | |
| 40839336 | Derived | Callaway CA, Varghese JM, Agnew ER, Sarfan LD, Harvey AG. An Examination of Training Quality and Provider Outcomes Across Two Generations of Train-the-Trainer. Adm Policy Ment Health. 2025 Sep;52(5):966-982. doi: 10.1007/s10488-025-01463-w. Epub 2025 Aug 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard TranS-C | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 29, 2024 |
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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).
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The assessment team will be blind to group allocation at post-treatment and six-month follow-up
|
| Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) | Behavioral | 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 Delayed Treatment | Other | 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). |
|
| 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-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. | 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-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. | 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. |
| 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. | 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. |
| 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. | 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). |
| 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. | 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). |
| Patient-level Outcome: Alcohol Intake |
Assesses past 30-day quantity and frequency of alcohol intake using a self-report questionnaire. |
| Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. |
| Patient-level Outcome: Substances Intake | Assesses past 30-day frequency of substance use using a self-report questionnaire. | Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. |
| Patient-level Outcome: Tobacco Intake | Assesses past 30-day quantity and frequency of tobacco intake using a self-report questionnaire. | Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. |
| Patient-level Outcome: Caffeine Intake | Assesses past 30-day quantity and frequency of caffeine intake using a self-report questionnaire. | Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. |
| Patient-level Outcome: Suicidal Ideation Questionnaire | Assesses past 30-day suicidal ideation using a self-report questionnaire. | Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. |
| Patient-level Outcome: Credibility Expectancy Questionnaire | Measures the credibility and expectation of improvement from TranS-C. The questionnaire includes 4 items. | Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment. |
| Patient-level Outcome: Utilization Questionnaire | Measures the elements of TranS-C that are most used. | Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment. |
| Patient-level Outcome: Utilization Questionnaire | Measures the elements of TranS-C that are most used. | Once at 6-month follow-up after treatment ends. |
| 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. | Once at baseline. |
| Provider-level Outcome: Checklist of Modules Delivered | Assesses which treatment modules were delivered by the providers using a self-report checklist. | Once at each session between patient and provider. |
| Provider-level Outcome: Adaptations to Evidence-Based Practices Scale | Assesses ad hoc modifications the provider made to the treatment using a self-report questionnaire. | Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment. |
| Provider-level Outcome: Semi-structured Interview | Assesses perceptions of TranS-C. | 20% of randomly selected providers and leadership once during the implementation phase and once during the sustainment phase. |
| Provider-level Outcome: Use of TranS-C Assessment | Assesses if providers continue to use TranS-C in a self-report questionnaire. | Once during the 1 year sustainment phase. |
| Provider-level Outcome: Session Attendance and Duration Log | Collect session date and duration (length of session). | Once at each session between patient and provider. |
| 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. | Through the first 2.5 years of the study, an average of 4 per month |
| Provider-level Outcome: Gold Standard Training Elements | Extent of gold standard training elements present in each training session, with respect to content and technique. | Through the first 2.5 years of the study, an average of 4 per month |
| Provider-level Outcome: Number of TranS-C Sessions | Number of sessions delivered to each enrolled patient by each provider. | Once per patient at posttreatment, which is 6 or 10 weeks after the beginning of treatment |
| Facilitator-level Outcome: Gold Standard Supervision Elements | Presence of gold-standard supervision elements covered during each supervision session. | Up to 30 months |
| 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). | Up to 30 months |
| 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. | Up to 30 months |
| Solano County Department of Health & Social Services, Behavioral Health Services |
| Fairfield |
| California |
| 94533 |
| United States |
| Santa Barbara County Department of Behavioral Wellness | Goleta | California | 93110 | United States |
| Kings County Behavioral Health | Hanford | California | 93230 | United States |
| Lake County Behavioral Health Services | Lucerne | California | 95458 | United States |
| Alameda County Behavioral Health Care Services | Oakland | California | 94606 | United States |
| Placer County Health and Human Services, Adult System of Care | Roseville | California | 95678 | United States |
| Monterey County Behavioral Health | Salinas | California | 93906 | United States |
| Bay Area Community Health | San Jose | California | 95148 | United States |
| County of Santa Cruz Behavioral Health Services for Children and Adults | Santa Cruz | California | 95060 | United States |
| 40799745 | Derived | Horwitz TB, Sarfan LD, Milner AE, Varghese J, Callaway CA, Harvey AG. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TSC) in Community Mental Health: Evaluating Self-Reported Psychiatric Disorders as a Predictor of Symptoms and Treatment Outcome. Res Sq [Preprint]. 2025 Aug 6:rs.3.rs-7189279. doi: 10.21203/rs.3.rs-7189279/v1. |
| 40634991 | Derived | Harvey AG, Agnew ER, Esteva Hache R, Spencer JM, Diaz M, Ovalle Patino E, Milner A, Dong L, Kilbourne AM, Buysse DJ, Callaway CA, Sarfan LD. A randomized trial of adapted versus standard versions of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction implemented via facilitation and delivered by community mental health providers: improving the "fit" of psychological treatments by adapting to context. Implement Sci. 2025 Jul 9;20(1):32. doi: 10.1186/s13012-025-01440-9. |
| 39249560 | Derived | Sarfan LD, Bajwa Z, Diaz M, Tiab S, Fisher K, Agnew ER, Howlett SA, Oliver S, Callaway CA, Harvey AG. "So Many Other Things Improve" with Transdiagnostic Treatment for Sleep and Circadian Problems: Interviews with Community Providers on Treating Clients with Serious Mental Illness. Adm Policy Ment Health. 2025 Mar;52(2):318-330. doi: 10.1007/s10488-024-01410-1. Epub 2024 Sep 9. |
| 36927461 | Derived | Sarfan LD, Agnew ER, Diaz M, Dong L, Fisher K, Spencer JM, Howlett SA, Hache RE, Callaway CA, Kilbourne AM, Buysse DJ, Harvey AG. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 1: study protocol for a hybrid type 2 effectiveness-implementation cluster-randomized trial. Trials. 2023 Mar 17;24(1):198. doi: 10.1186/s13063-023-07148-9. |
| Adapted TranS-C |
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 Community Mental Health Center (CMHC) context. |
| Providers | Provider data 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. |
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| Patients - Immediate TranS-C |
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| Patients - UC-DT | 6-month follow up was collected for immediate TranS-C only |
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| NOT COMPLETED |
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Provider data 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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age for patients. | Mean | Standard Deviation | years |
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| Age, Continuous | Age for providers. | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Education | Data not collected for this Baseline Measure from providers. | Count of Participants | Participants |
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| Employment | Data not collected for this Baseline Measure from providers. | Count of Participants | Participants |
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| Civil Status | Data not collected for this Baseline Measure from providers. | Count of Participants | Participants |
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| Living Arrangement | Data not collected for this Baseline Measure from providers. | Count of Participants | Participants |
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| Government Assistance | Some patients endorsed more than one government assistance category. | Data not collected for this Baseline Measure from providers. | Count of Participants | Participants |
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| Annual Household Income | Data not collected for this Baseline Measure from providers. | Count of Participants | Participants |
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| Self-reported Diagnosis | Some patients endorsed more than one self-reported diagnosis. | Data not collected for this Baseline Measure from providers. | Count of Participants | Participants |
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| Education | Data not collected for this Baseline Measure from providers. | Mean | Standard Deviation | years |
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| Degree Type | Data not collected for this Baseline Measure from patients. | Count of Participants | Participants |
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| Therapeutic Approach | Some providers endorsed more than one therapeutic approach. | Data not collected for this Baseline Measure from patients. | Count of Participants | Participants |
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| Licensure | Data not collected for this Baseline Measure from patients. | Count of Participants | Participants |
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| Caseload | Data not collected for this Baseline Measure from patients. | Mean | Standard Deviation | number of patients |
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| Employment Duration | Data not collected for this Baseline Measure from patients. | Mean | Standard Deviation | years |
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| Years Since Degree Earned | Data not collected for this Baseline Measure from patients. | Mean | Standard Deviation | years |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | Mid-treatment and 6-month follow-up assessments were collected following TranS-C but were not collected following Usual Care (UC-DT). | Posted | Mean | Standard Error | T-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. |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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). |
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| 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. | Mid-treatment and 6-month follow-up assessments were collected following TranS-C but were not collected following Usual Care (UC-DT). | Posted | Mean | Standard Deviation | T-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. |
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| 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. | Mid-treatment and 6-month follow-up assessments were collected following TranS-C but were not collected following Usual Care (UC-DT). | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| 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. | 6-month follow-up assessments were collected following TranS-C but were not collected following Usual Care (UC-DT). | Posted | Mean | Standard Deviation | score on a 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. |
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| 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. | 6-month follow-up assessments were collected following TranS-C but were not collected following Usual Care (UC-DT). | Posted | Mean | Standard Deviation | score on a 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. |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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). |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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). |
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| Other Pre-specified | Patient-level Outcome: Midpoint of Sleep Measure | Assesses circadian functioning by calculating the midpoint between falling asleep time and rise time. | Not Posted | 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. | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Patient-level Outcome: Alcohol Intake | Assesses past 30-day quantity and frequency of alcohol intake using a self-report questionnaire. | Not Posted | Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Patient-level Outcome: Substances Intake | Assesses past 30-day frequency of substance use using a self-report questionnaire. | Not Posted | Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Patient-level Outcome: Tobacco Intake | Assesses past 30-day quantity and frequency of tobacco intake using a self-report questionnaire. | Not Posted | Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Patient-level Outcome: Caffeine Intake | Assesses past 30-day quantity and frequency of caffeine intake using a self-report questionnaire. | Not Posted | Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Patient-level Outcome: Suicidal Ideation Questionnaire | Assesses past 30-day suicidal ideation using a self-report questionnaire. | Not Posted | Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up. | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Patient-level Outcome: Credibility Expectancy Questionnaire | Measures the credibility and expectation of improvement from TranS-C. The questionnaire includes 4 items. | Not Posted | Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment. | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Patient-level Outcome: Utilization Questionnaire | Measures the elements of TranS-C that are most used. | Not Posted | Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment. | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Patient-level Outcome: Utilization Questionnaire | Measures the elements of TranS-C that are most used. | Not Posted | Once at 6-month follow-up after treatment ends. | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | Once at baseline. | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Provider-level Outcome: Checklist of Modules Delivered | Assesses which treatment modules were delivered by the providers using a self-report checklist. | Not Posted | Once at each session between patient and provider. | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment. | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Provider-level Outcome: Semi-structured Interview | Assesses perceptions of TranS-C. | Not Posted | 20% of randomly selected providers and leadership once during the implementation phase and once during the sustainment phase. | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Provider-level Outcome: Use of TranS-C Assessment | Assesses if providers continue to use TranS-C in a self-report questionnaire. | Not Posted | Once during the 1 year sustainment phase. | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Provider-level Outcome: Session Attendance and Duration Log | Collect session date and duration (length of session). | Not Posted | Once at each session between patient and provider. | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | Through the first 2.5 years of the study, an average of 4 per month | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | Through the first 2.5 years of the study, an average of 4 per month | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Provider-level Outcome: Number of TranS-C Sessions | Number of sessions delivered to each enrolled patient by each provider. | Not Posted | Once per patient at posttreatment, which is 6 or 10 weeks after the beginning of treatment | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Facilitator-level Outcome: Gold Standard Supervision Elements | Presence of gold-standard supervision elements covered during each supervision session. | Not Posted | Up to 30 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | Not Posted | Up to 30 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | Up to 30 months | Participants |
Through study completion, an average of 12 months.
Provider data 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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 74 | 0 | 74 | 0 | 74 |
| EG001 | 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. | 0 | 124 | 0 | 124 | 0 | 124 |
| EG002 | 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. | 0 | 71 | 0 | 71 | 0 | 71 |
| EG003 | 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. | 0 | 127 | 0 | 127 | 0 | 127 |
| EG004 | 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. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG005 | 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. | 0 | 63 | 0 | 63 | 0 | 63 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor of Clinical Psychology | Department of Psychology, University of California, Berkeley | 5104736490 | aharvey@berkeley.edu |
| May 18, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D021081 | Chronobiology Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D012890 | Sleep |
| ID | Term |
|---|---|
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Food Stamps |
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| Supplemental Security Income/Social Security Disability Insurance |
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| Supplemental Nutrition Assistance Program |
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| None |
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| Other/category not listed |
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| Missing/declined to answer |
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| Psychosis |
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| Bipolar Disorder |
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| Major Depressive Disorder |
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| Anxiety disorders |
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| Obsessive-compulsive and related disorders |
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| Trauma and stressor-related disorders |
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| Dissociative disorders |
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| Personality disorders |
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| Feeding and eating disorders |
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| Substance-related and addictive disorders |
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| Other/category not listed |
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| Missing/declined to answer |
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| Family Systems |
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| Cognitive Behavioral Therapy |
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| Psychodynamic |
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| Humanistic |
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| Integrative/Holistic |
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| None |
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| Missing/declined to answer |
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| OG004 |
| Immediate TranS-C |
Standard and Adapted TranS-C combined for participants randomized to the immediate condition. |
| OG005 | UC-DT | Standard and Adapted TranS-C combined for participants randomized to the UC-DT condition. |
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| Mid-treatment |
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| Post-treatment |
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| 6-month follow-up |
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| SEM |
| 0.95 |
| Coefficient of indirect effect |
| 0.17 |
| 2-Sided |
| 95 |
| -4.62 |
| 4.95 |
| Superiority |
| 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. | SEM | 0.95 | Coefficient of indirect effect | 0.09 | 2-Sided | 95 | -2.39 | 2.56 | Superiority |
| 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. | SEM | 0.88 | Coefficient of indirect effect | -0.16 | 2-Sided | 95 | -2.31 | 1.98 | Superiority |
| 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. | SEM | 0.88 | Coefficient of indirect effect | -0.13 | 2-Sided | 95 | -3.10 | 2.31 | Superiority |
| 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. | SEM | 0.79 | Coefficient of indirect effect | -0.50 | 2-Sided | 95 | -2.18 | 1.66 | Superiority |
| 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. | SEM | 0.79 | Coefficient of indirect effect | -0.26 | 2-Sided | 95 | -2.18 | 1.66 | Superiority |
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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | Immediate TranS-C | Standard and Adapted TranS-C combined for participants randomized to the immediate condition. |
| OG005 | UC-DT | Standard and Adapted TranS-C combined for participants randomized to the UC-DT condition. |
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| OG001 | Adapted TranS-C (Immediate) | 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. 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | Immediate TranS-C | Standard and Adapted TranS-C combined for participants randomized to the immediate condition. |
| OG005 | UC-DT | Standard and Adapted TranS-C combined for participants randomized to the UC-DT condition. |
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| OG002 | 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. |
| OG003 | 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. |
| OG004 | Immediate TranS-C | Standard and Adapted TranS-C combined for participants randomized to the immediate condition. |
| OG005 | UC-DT | Standard and Adapted TranS-C combined for participants randomized to the UC-DT condition. |
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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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | Immediate TranS-C | Standard and Adapted TranS-C combined for participants randomized to the immediate condition. |
| OG005 | UC-DT | Standard and Adapted TranS-C combined for participants randomized to the UC-DT condition. |
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| OG001 | 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. 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. |
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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. |
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