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

Sleep Disorder Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05805657
• Other study ID #: R01MH120147_P2
• Secondary ID: R01MH120147
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 14, 2020
• Est. completion date: June 15, 2024

Study information

• Verified date: May 2024
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 190
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronobiology Disorders
• Circadian Dysregulation
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Behavioral:
• 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.

Other:
• 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).

Locations

Country	Name	City	State
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	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

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient-level outcome: Alcohol Intake	Assesses past 30-day quantity and frequency of alcohol intake using a self-report questionnaire.	Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Other	Patient-level outcome: Substances Intake	Assesses past 30-day frequency of substance use using a self-report questionnaire.	Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Other	Patient-level outcome: Tobacco Intake	Assesses past 30-day quantity and frequency of tobacco intake using a self-report questionnaire.	Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Other	Patient-level outcome: Caffeine Intake	Assesses past 30-day quantity and frequency of caffeine intake using a self-report questionnaire.	Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Other	Patient-level outcome: Suicidal Ideation Questionnaire	Assesses past 30-day suicidal ideation using a self-report questionnaire.	Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Other	Patient-level outcome: Credibility Expectancy Questionnaire	Measures the credibility and expectation of improvement from TranS-C. The questionnaire includes 4 items.	Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment.
Other	Patient-level outcome: Utilization Questionnaire	Measures the elements of TranS-C that are most used.	Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment.
Other	Patient-level outcome: Utilization Questionnaire	Measures the elements of TranS-C that are most used.	Once at 6-month follow-up after treatment ends.
Other	Patient-level outcome: Duke Checklist of Medical Conditions & Symptoms	Assesses physical illness or neurological degenerative disease directly related to the onset and course of the sleep and circadian dysfunction.	Once at baseline.
Other	Provider-level outcome: Checklist of Modules Delivered	Assesses which treatment modules were delivered by the providers using a self-report checklist.	Once at each session between patient and provider.
Other	Provider-level outcome: Adaptations to Evidence-Based Practices Scale	Assesses ad hoc modifications the provider made to the treatment using a self-report questionnaire.	Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment.
Other	Provider-level outcome: Use of TranS-C Assessment	Assesses if providers continue to use TranS-C in a self-report questionnaire.	Once during the 1 year sustainment phase.
Other	Provider-level outcome: Session attendance and duration log	Collect session date and duration (length of session).	Once at each session between patient and provider.
Other	Provider-level outcome: Training evaluation/knowledge test	Provider evaluation of the training; provider knowledge of content covered in the training; provider willingness and confidence in delivering TranS-C.	Through the first 2.5 years of the study, an average of 4 per month
Other	Provider-level outcome: Gold Standard Training Elements	Extent of gold standard training elements present in each training session, with respect to content and technique.	Through the first 2.5 years of the study, an average of 4 per month
Other	Provider-level outcome: Number of TranS-C Sessions	Number of sessions delivered to each enrolled patient by each provider.	Once per patient at posttreatment, which is 6 or 10 weeks after the beginning of treatment
Other	Facilitator-level outcome: Implementation Log	Weekly record of facilitator activities, amount of time per activity, county, year, type of communication, implementation strategies, target(s), intended outcome(s).	Up to 30 months
Other	Facilitator-level outcome: Meeting Log	Weekly record of community meeting details as applicable, including: county, generation, level of contact (i.e., leadership, providers), type/modality of contact, length of meeting, number of attendees, recording, general description, standardized description, main presenter and role of UC Berkeley staff.	Up to 30 months
Other	Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance	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).	Change from baseline to mid-treatment, which is 2 or 4 weeks after the beginning of treatment
Other	Provider-level outcome: Acceptability Intervention Measure	Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire and provider feedback.	Change from baseline to mid-treatment, which is 2 or 4 weeks after the beginning of treatment for each client
Primary	Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance	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).	Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Primary	Provider-level outcome: Acceptability Intervention Measure	Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire and provider feedback.	Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment.
Secondary	Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment	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).	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.
Secondary	Patient-level outcome: Composite Sleep Health Score	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).	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.
Secondary	Patient-level outcome: Midpoint of Sleep Measure	Assesses circadian functioning by calculating the midpoint between falling asleep time and rise time.	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.
Secondary	Patient-level outcome: Sheehan Disability Scale	Assesses functional impairment on a scale from 0 to 30, where higher scores mean higher impairment.	Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Secondary	Patient-level outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure	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).	Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Secondary	Provider-level outcome: Intervention Appropriateness Measure	Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire	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.
Secondary	Provider-level outcome: Feasibility of Intervention Measure	Assesses provider perceptions of the feasibility of the intervention using a self-report questionnaire.	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.