Implementing and Sustaining a Sleep Treatment to Improve Community Mental Health Part 3: Sustainment
NCT ID: NCT05956678
Last Updated: 2024-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2023-04-01
2024-04-01
Brief Summary
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Detailed Description
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Aim 1: Report the sustainment outcomes of TranS-C after implementation support has ended.
Aim 2: Evaluate whether manipulating fit to context predicts sustainment outcomes. It is hypothesized that providers in Adapted TranS-C will report better sustainment outcomes (i.e., activities, benefits, and capacity) relative to Standard TranS-C.
Aim 3: Test whether provider perceptions of fit-operationalized as acceptability, appropriateness, and feasibility-mediate the relation between treatment condition (Standard versus Adapted TranS-C) and sustainment outcomes. It is hypothesized that Adapted TranS-C, compared to Standard TranS-C, will predict better sustainment outcomes (i.e., activities, benefits, and capacity) indirectly through better provider perceptions of fit.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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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.
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.
Adapted TranS-C
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 and is comprised of 4 cross-cutting interventions featured in every session, 5 modules that apply to the vast majority of patients, and 1 optional module used less commonly, depending on the presentation.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Support from CMHC leadership
* Employed, able to deliver, or have delivered patient-facing services to patients within a CMHC
* Have attended a TranS-C training
* CMHC site of employment has been in a period of sustainment (i.e., implementation activities have ended) for at least three months
* volunteer to participate and formally consent to participate
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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University of California, Berkeley
OTHER
Responsible Party
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Principal Investigators
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Allison Harvey, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Berkeley
Laurel Sarfan, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Berkeley
Locations
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Contra Costa Health, Housing, and Homeless Services Division
Concord, California, United States
Solano County Department of Health & Social Services, Behavioral Health Services
Fairfield, California, United States
Santa Barbara County Department of Behavioral Wellness
Goleta, California, United States
Kings County Behavioral Health
Hanford, California, United States
Lake County Behavioral Health Services
Lucerne, California, United States
Alameda County Behavioral Health Care Services
Oakland, California, United States
Placer County Health and Human Services, Adult System of Care
Roseville, California, United States
Monterey County Behavioral Health
Salinas, California, United States
Bay Area Community Health
San Jose, California, United States
County of Santa Cruz Behavioral Health Services for Children and Adults
Santa Cruz, California, United States
Countries
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References
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Sarfan LD, Agnew ER, Diaz M, Cogan A, Spencer JM, Esteva Hache R, Wiltsey Stirman S, Lewis CC, Kilbourne AM, Harvey AG. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 3: study protocol to evaluate sustainment in a hybrid type 2 effectiveness-implementation cluster-randomized trial. Trials. 2024 Jan 15;25(1):54. doi: 10.1186/s13063-023-07900-1.
Sarfan LD, Agnew ER, Diaz M, Cogan A, Spencer JM, Hache RE, Stirman SW, Lewis CC, Kilbourne AM, Harvey A. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 3: Study protocol to evaluate sustainment in a hybrid type 2 effectiveness-implementation cluster-randomized trial. Res Sq [Preprint]. 2023 Oct 30:rs.3.rs-3328993. doi: 10.21203/rs.3.rs-3328993/v1.
Other Identifiers
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R01MH120147_P3
Identifier Type: -
Identifier Source: org_study_id
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