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

University of California (UC), Berkeley

Status: Completed

Conditions: Sleep Disorder; Circadian Dysregulation

Treatments: Other: Usual Care Delayed Treatment; Behavioral: Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C); Behavioral: Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)

Study type: Interventional

Funder types: Other

Identifiers

NCT05805657

R01MH120147_P2

R01MH120147

Details and patient eligibility

About

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.

Full 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.

Enrollment: 196 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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196 participants in 3 patient groups

Standard TranS-C

Experimental group

Description:

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.

Treatment:

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

Adapted TranS-C

Experimental group

Description:

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.

Treatment:

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

UC-DT

Active Comparator group

Description:

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).

Treatment:

Other: Usual Care Delayed Treatment