Clinical trial NCT05805657: Implementing and Sustaining a Sleep Treatment to Improve Community Mental Health Part 2: Train-the-Trainer
Official title: Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment to Improve Severe Mental Illness Outcomes in Community Mental Health Part 2: Train-the-Trainer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorder
Circadian Dysregulation
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
timeFrame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
measure: Provider-level outcome: Acceptability Intervention Measure
timeFrame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment.
Secondary outcomes:
measure: Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment
timeFrame: 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.
measure: Patient-level outcome: Composite Sleep Health Score
timeFrame: 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.
measure: Patient-level outcome: Midpoint of Sleep Measure
timeFrame: 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.
measure: Patient-level outcome: Sheehan Disability Scale
timeFrame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
measure: Patient-level outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure
timeFrame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
measure: Provider-level outcome: Intervention Appropriateness Measure
timeFrame: 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.
measure: Provider-level outcome: Feasibility of Intervention Measure
timeFrame: 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.
Other outcomes:
measure: Patient-level outcome: Alcohol Intake
timeFrame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
measure: Patient-level outcome: Substances Intake
timeFrame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
measure: Patient-level outcome: Tobacco Intake
timeFrame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
measure: Patient-level outcome: Caffeine Intake
timeFrame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
measure: Patient-level outcome: Suicidal Ideation Questionnaire
timeFrame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
measure: Patient-level outcome: Credibility Expectancy Questionnaire
timeFrame: Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment.
measure: Patient-level outcome: Utilization Questionnaire
timeFrame: Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment.
measure: Patient-level outcome: Utilization Questionnaire
timeFrame: Once at 6-month follow-up after treatment ends.
measure: Patient-level outcome: Duke Checklist of Medical Conditions & Symptoms
timeFrame: Once at baseline.
measure: Provider-level outcome: Checklist of Modules Delivered
timeFrame: Once at each session between patient and provider.
measure: Provider-level outcome: Adaptations to Evidence-Based Practices Scale
timeFrame: Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment.
measure: Provider-level outcome: Use of TranS-C Assessment
timeFrame: Once during the 1 year sustainment phase.
measure: Provider-level outcome: Session attendance and duration log
timeFrame: Once at each session between patient and provider.
measure: Provider-level outcome: Training evaluation/knowledge test
timeFrame: Through the first 2.5 years of the study, an average of 4 per month
measure: Provider-level outcome: Gold Standard Training Elements
timeFrame: Through the first 2.5 years of the study, an average of 4 per month
measure: Provider-level outcome: Number of TranS-C Sessions
timeFrame: Once per patient at posttreatment, which is 6 or 10 weeks after the beginning of treatment
measure: Facilitator-level outcome: Implementation Log
timeFrame: Up to 30 months
measure: Facilitator-level outcome: Meeting Log
timeFrame: Up to 30 months
measure: Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
timeFrame: Change from baseline to mid-treatment, which is 2 or 4 weeks after the beginning of treatment
measure: Provider-level outcome: Acceptability Intervention Measure
timeFrame: Change from baseline to mid-treatment, which is 2 or 4 weeks after the beginning of treatment for each client
Locations:
city: Concord
country: United States
facility: Contra Costa Health, Housing, and Homeless Services Division
state: California
city: Fairfield
country: United States
facility: Solano County Department of Health & Social Services, Behavioral Health Services
state: California
city: Hanford
country: United States
facility: Kings County Behavioral Health
state: California
city: Lucerne
country: United States
facility: Lake County Behavioral Health Services
state: California
city: Oakland
country: United States
facility: Alameda County Behavioral Health Care Services
state: California
city: Roseville
country: United States
facility: Placer County Health and Human Services, Adult System of Care
state: California
city: Salinas
country: United States
facility: Monterey County Behavioral Health
state: California
city: San Jose
country: United States
facility: Bay Area Community Health
state: California
city: Santa Cruz
country: United States
facility: County of Santa Cruz Behavioral Health Services for Children and Adults
state: California
Study officials:
affiliation: University of California, Berkeley
name: Allison Harvey, PhD
role: PRINCIPAL_INVESTIGATOR
References: