Implementing and Sustaining a Sleep Treatment to Improve Community Mental Health Part 2: Train-the-Trainer

NCT ID: NCT05805657

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-14
• Study Completion Date: 2024-05-08

Brief Summary

The train-the-trainer (TTT) approach is a promising method of sustaining training efforts in community mental health centers (CMHCs). This study will test the implementation and effectiveness outcomes of a sleep treatment delivered by CMHC providers who are trained and supervised within CMHCs via TTT. The investigators will test two versions of the sleep treatment, a "Standard" version and an "Adapted" version that has been adapted using theory, data and stakeholder inputs to improve the fit for SMI patients treated in community mental health centers.

Detailed Description

There are significant barriers to widespread implementation and sustainment of evidence-based psychological treatments (EBPTs) in community mental health centers (CMHCs), including insufficient time and funding, shortage of trainers and consultants, and staff turnover. The investigators propose to evaluate one possible solution, the train-the-trainer (TTT) approach, in the context of a transdiagnostic EBPT for sleep and circadian dysfunction-the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)- for serious mental illness (SMI) in CMHCs. This entry describes the Train-the-Trainer Phase, the second of a three-phase hybrid type 2 effectiveness-implementation trial conducted to test TranS-C in CMHCs.

TTT is a training structure with multiple levels, called "Generations." First, external expert trainers train an initial cohort of providers in a specific EBPT ("Generation 1 providers"). Next, Generation 1 providers are offered additional training in how to train others in the EBPT and become "local trainers." These local trainers then train the next cohort of providers within their organization ("Generation 2 providers").

The Train-the-Trainer Phase builds upon the first phase, the Implementation Phase (NCT04154631), in which implementation and effectiveness outcomes of two versions of TranS-C, Standard and Adapted are compared, with CMHC providers, who are trained by treatment experts. Adapted TranS-C is a version of TranS-C designed to improve 'fit' with the CMHC context. In the Train-the-Trainer Phase, the aim is to test implementation and effectiveness outcomes of Standard and Adapted TranS-C with CMHC providers who are trained and supervised within CMHCs (i.e., Generation 2 of TTT).

In the Implementation Phase, 10 CMHC clinic sites were cluster randomized to either Standard or Adapted TranS-C. Nine CMHCs continued participation into the Train-the-Trainer Phase. Within each CMHC site, patients are randomized to immediate TranS-C or to Usual Care followed by Delayed Treatment (UC-DT). Generation 2 patients (n=130) will be assessed pre, mid and post-treatment and at 6 month follow-up. UC Berkeley will coordinate the research, facilitate implementation, collect data, etc. Generation 2 providers (n=60), trained by local trainers within an established network of CMHCs, will implement TranS-C and will be assessed at pre and post-treatment. SA1 is to confirm that both Standard vs. Adapted TranS-C, compared to UC-DT, improve sleep and circadian functioning and reduce functional impairment and disorder-focused psychiatric symptoms for Generation 2 patients. SA2 is to evaluate the fit, to the CMHC context, of Standard vs. Adapted TranS-C via Generation 2 provider ratings of acceptability, appropriateness and feasibility. SA3 will examine if better fit, operationalized via Generation 2 provider ratings of acceptability, mediates the relationship between treatment condition and Generation 2 patient outcome. This research will determine if (1) sleep and circadian problems can be effectively addressed in SMI by CMHC providers trained and supervised within CMHCs via the train-the-trainer approach, (2) test two variations of TranS-C that each have unique advantages and focus on community providers and typical community patients.

Conditions

Sleep Disorder; Circadian Dysregulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)

Intervention Type: BEHAVIORAL

The Adapted version was derived from Standard TranS-C. It was developed to improve the fit of the treatment with the CMHC context.

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).

Group Type: ACTIVE_COMPARATOR

Usual Care Delayed Treatment

Intervention Type: 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).

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Usual Care Delayed Treatment

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Employed in participating CMHCs
• Completed a Generation 1 TranS-C training (i.e., led by UC Berkeley expert trainers)
• Volunteer to participate and formally consent to participate

• Publicly funded adult mental health outpatient services
• Support from CMHC leadership

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Berkeley

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allison Harvey, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Berkeley

Locations

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

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

United States

References

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.

Reference Type: DERIVED

PMID: 40799745 (View on PubMed)

Harvey A, Agnew ER, Hache RE, Callaway CA, Patino EO, Milner A, Spencer JM, Diaz M, Dong L, Kilbourne AM, Buysse DJ, Stice E, Sarfan LD. A randomized trial of Adapted versus Standard versions the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TSC) implemented via facilitation and delivered by community mental health providers using train-the-trainer. Res Sq [Preprint]. 2025 Jul 14:rs.3.rs-6414484. doi: 10.21203/rs.3.rs-6414484/v1.

Reference Type: DERIVED

PMID: 40709255 (View on PubMed)

Callaway CA, Sarfan LD, Agnew ER, Dong L, Spencer JM, Hache RE, Diaz M, Howlett SA, Fisher KR, Yates HEH, Stice E, 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 2: study protocol for a hybrid type 2 effectiveness-implementation cluster-randomized trial using train-the-trainer. Trials. 2023 Aug 7;24(1):503. doi: 10.1186/s13063-023-07523-6.

Reference Type: DERIVED

PMID: 37550730 (View on PubMed)

Callaway CA, Sarfan LD, Agnew ER, Dong L, Spencer JM, Hache RE, Diaz M, Howlett SA, Fisher KR, Yates HEH, Stice E, 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 2: Study protocol for a hybrid type 2 effectiveness-implementation cluster- randomized trial using train-the-trainer. Res Sq [Preprint]. 2023 Jun 17:rs.3.rs-2943787. doi: 10.21203/rs.3.rs-2943787/v1.

Reference Type: DERIVED

PMID: 37398014 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01MH120147

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01MH120147_P2

Identifier Type: -

Identifier Source: org_study_id