NCT Number: NCT05805657
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Contra Costa Health, Housing, and Homeless Services Division, Concord, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The inclusion criteria for the CMHC local trainers are:
The inclusion criteria for CMHCs are:
The inclusion criteria for CMHC providers are:
Consumers must meet the following inclusion criteria:
Exclusion criteria
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.
The Adapted version was derived from Standard TranS-C. It was developed to improve the fit of the treatment with the CMHC context.
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).
Time frame: Baseline, mid-treatment (2/4 weeks post-baseline), post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale. The 8-item short version scale assesses perceived sleep problems (e.g., sleep quality, perception of sleep difficulties) over a 7-day period. Items are rated on a 5-point scale ranging from 1 (not at all) to 5 (very much). Raw scores are summed to produce a single score, resulting in a range from 8 to 40. Raw scores are converted to t-scores using treatment manuals. T-scores range from 30.5 to 77.5. A T-score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate worse sleep disturbance.
Time frame: Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS- C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C).
Assesses provider perceptions of the acceptability of the treatment intervention using a self-report questionnaire. The 4-item scale is rated on a 5-point scale from 1 (completely disagree) to 5 (completely agree). A total score is calculated by averaging all four items. Total scores range from 1 to 5, with higher scores indicating greater perceptions of acceptability.
Time frame: Baseline, mid-treatment (2/4 weeks post-baseline), post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Impairment Scale. The 8-item short version scale assesses perceived sleep problems during waking hours (e.g., alertness, sleepiness, tiredness) over a 7-day period. Items are rated on a 5-point scale ranging from 1 (not at all) to 5 (very much). Raw scores are summed to produce a single score, resulting in a range from 8 to 40. Raw scores are converted to t-scores using treatment manuals. T-scores range from 30.1 to 80.1. A T-score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate worse sleep-related impairment.
Time frame: Baseline, mid-treatment (2/4 weeks post-baseline), post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
Composite Sleep Health Score is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint sleep fluctuation across a 7-day sleep diary < 1 hour), Satisfaction (Sleep quality question on PROMIS-Sleep Disturbance (PROMIS = Patient-Reported Outcomes Measurement Information System)), Alertness (Daytime sleepiness question on PROMIS-Sleep Related Impairment (PROMIS = Patient-Reported Outcomes Measurement Information System)), Timing (Mean midpoint sleep across the 7 day sleep diary between 2 and 4 AM), Efficiency (Average sleep efficiency based on the 7 day sleep diary ≥ 85%), and Duration (Total Sleep Time average based on 7 day sleep diary between 7 and 9 hours). Each dimension was dichotomized such that 1 = good /yes; 0 = poor/no). Total composite sleep health score ranges from 0 to 6, with larger values indicating better sleep health.
Time frame: Baseline, post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
The Sheehan Disability Scale (SDS) assesses impairment in work/school, social, and family life. Items are rated on a scale from 0 (not at all) to 10 (extremely). Items are summed to produce a single score. Scores range from 0 to 30, with higher scores indicating higher functional impairment.
Time frame: Baseline, post-treatment (4/8 weeks post-baseline - the UC-DT post-assessment follows the same timeframe post-usual care and delayed treatment) for Adapted/Standard TranS-C, respectively, and 6-month follow-up.
The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure (DSM-5) assesses psychiatric symptoms across 13 mental health domains. Participants rate on a 5-point scale how often they were bothered by each symptom on a scale from 0 (not at all) to 4 (nearly every day). Scores range from 0 to 52, with higher scores indicating more severe symptoms.
Time frame: Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS- C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C).
Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire. The 4-item scale is rated on a 5-point scale from 1 (completely disagree) to 5 (completely agree). A total score is calculated by averaging all four items. Total scores range from 1 to 5, with higher scores indicating greater perceptions of appropriateness.
Time frame: Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS-C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C).
Assesses provider perceptions of the feasibility of the treatment intervention using a self-report questionnaire. The 4- item scale is rated on a 5-point scale from 1 (completely disagree) to 5 (completely agree). A total score is calculated by averaging all four items. Total scores range from 1 to 5, with higher scores indicating greater perceptions of feasibility.
Time frame: 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.
Time frame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Assesses past 30-day quantity and frequency of alcohol intake using a self-report questionnaire.
Time frame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Assesses past 30-day frequency of substance use using a self-report questionnaire.
Time frame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Assesses past 30-day quantity and frequency of tobacco intake using a self-report questionnaire.
Time frame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Assesses past 30-day quantity and frequency of caffeine intake using a self-report questionnaire.
Time frame: Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.
Assesses past 30-day suicidal ideation using a self-report questionnaire.
Time frame: Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment.
Measures the credibility and expectation of improvement from TranS-C. The questionnaire includes 4 items.
Time frame: Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment.
Measures the elements of TranS-C that are most used.
Time frame: Once at 6-month follow-up after treatment ends.
Measures the elements of TranS-C that are most used.
Time frame: Once at baseline.
Assesses physical illness or neurological degenerative disease directly related to the onset and course of the sleep and circadian dysfunction.
Time frame: Once at each session between patient and provider.
Assesses which treatment modules were delivered by the providers using a self-report checklist.
Time frame: Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment.
Assesses ad hoc modifications the provider made to the treatment using a self-report questionnaire.
Time frame: Once during the 1 year sustainment phase.
Assesses if providers continue to use TranS-C in a self-report questionnaire.
Time frame: Once at each session between patient and provider.
Collect session date and duration (length of session).
Time frame: Through the first 2.5 years of the study, an average of 4 per month
Provider evaluation of the training; provider knowledge of content covered in the training; provider willingness and confidence in delivering TranS-C.
Time frame: Through the first 2.5 years of the study, an average of 4 per month
Extent of gold standard training elements present in each training session, with respect to content and technique.
Time frame: Once per patient at posttreatment, which is 6 or 10 weeks after the beginning of treatment
Number of sessions delivered to each enrolled patient by each provider.
Time frame: Up to 30 months
Weekly record of facilitator activities, amount of time per activity, county, year, type of communication, implementation strategies, target(s), intended outcome(s).
Time frame: Up to 30 months
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.
Time frame: Change from baseline to mid-treatment, which is 2 or 4 weeks after the beginning of treatment
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).
Time frame: Change from baseline to mid-treatment, which is 2 or 4 weeks after the beginning of treatment for each client
Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire and provider feedback.
University of California, Berkeley
Other
Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment to Improve Severe Mental Illness Outcomes in Community Mental Health Part 2: Train-the-Trainer
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