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

Not Applicable

Completed

• Conditions: Sleep Disorder; Circadian Dysregulation
• Interventions: Behavioral: Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C); Behavioral: Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C); Other: Usual Care Delayed Treatment

• Registration Number: NCT05805657
• Lead Sponsor: University of California, Berkeley

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.

Study Timeline

• Study Start: 2020-12-14
• Study First Submitted: 2023-03-10
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-04-10
• Primary Completion: 2024-05-08
• Study Completion: 2024-05-08
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

The inclusion criteria for the CMHC local trainers are:

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

The inclusion criteria for CMHCs are:

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

The inclusion criteria for CMHC providers are:

• Employed or able to deliver client-facing services to CMHC clients
• Interest in learning and delivering TranS-C
• Volunteer to participate and formally consent to participate

Consumers must meet the following inclusion criteria:

• Aged 18 years and older
• Meet criteria for an SMI per self-report and confirmed by referring provider or administration of the Mini International Neuropsychiatric Interview (MINI) (DSM-5, Version 7.0.0) by a licensed clinical social worker on the research team
• Exhibit a sleep or circadian disturbance as determined by endorsing 4 "quite a bit" or 5 "very much" (or the equivalent for reverse scored items) on one or more PROMIS-SD questions
• Receiving the standard of care for the SMI and consent to regular communications between the research team and provider
• Consent to access their medical record and participate in assessments
• Guaranteed place to sleep for at least 2 months that is not a shelter

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adapted TranS-C	Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (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.
Standard TranS-C	Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (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.
UC-DT	Usual Care Delayed Treatment	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).

Primary Outcome Measures

Name	Time	Method
Provider-level outcome: Acceptability Intervention Measure	Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment.	Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire and provider feedback.
Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance	Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.	Assesses perceived functional impairments related to sleep problems using a self-report questionnaire. The minimum value is 8. The maximum value is 40. Higher scores mean more sleep disturbance (worse outcome).

Secondary Outcome Measures

Name	Time	Method
Patient-level outcome: Composite Sleep Health Score	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.	Composite Sleep Health Score which is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint fluctuation), Satisfaction (Sleep quality question on PROMIS-SD), Alertness (Daytime sleepiness question on PROMIS-SRI), Timing (Mean midpoint), Efficiency (Sleep efficiency) and Duration (Total Sleep Time).
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.
Patient-level outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure	Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.	Assesses disorder-focused psychiatric symptoms using a self-report questionnaire. Each item on the measure is rated on a 5-point scale (from 0-4), where higher scores indicate a higher frequency of psychiatric symptoms (worse outcome).
Provider-level outcome: Feasibility of Intervention Measure	Change from baseline, to mid-treatment, which is 2 or 4 weeks after the beginning of treatment for each client, and to post-treatment, which is 6 or 10 weeks after the beginning of treatment.	Assesses provider perceptions of the feasibility of the intervention using a self-report questionnaire.
Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment	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 perceived functional impairments related to sleep problems in a self-report questionnaire. The minimum value is 16. The maximum value is 80. Higher scores mean more sleep related problems (worse outcome).
Patient-level outcome: Sheehan Disability Scale	Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.	Assesses functional impairment on a scale from 0 to 30, where higher scores mean higher impairment.
Provider-level outcome: Intervention Appropriateness Measure	Change from baseline, to mid-treatment, which is 2 or 4 weeks after the beginning of treatment for each client, and to post-treatment, which is 6 or 10 weeks after the beginning of treatment.	Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire

Trial Locations

Locations (9)

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

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