Implementing and Sustaining a Sleep Treatment to Improve Community Mental Health Outcomes
Study Details
Study Description
Brief Summary
The sleep disturbance commonly experienced by individuals with a severe mental illness (SMI) reduces these individuals' capacity to function and contributes to key symptoms. This study will test the effects of a sleep treatment that has been adapted using theory, data and stakeholder inputs to improve the fit for SMI patients treated in community mental health centers (CMHCs), relative to the standard treatment. The investigators will also determine if the adapted and standard versions can improve sleep, improve functioning and reduce symptoms.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
An obstacle to the roll-out of evidence-based treatments (EBTs) for severe mental illness (SMI) is that the context for the implementation typically differs from the original testing context causing a lack of "fit" between the setting and the EBT. The investigators propose to evaluate if adapting a specific treatment to improve the contextual fit improves outcomes in a setting that typifies this challenge-community mental health centers (CMHCs).
Following the Experimental Therapeutics Approach, the target is sleep and circadian dysfunction. In SMI, sleep and circadian dysfunction undermines affect regulation, cognitive function and physical health, predicts the onset and worsening of symptoms and is often chronic even with evidence-based SMI treatment. Prior treatment studies have been disorder-focused-they have treated a specific sleep problem (e.g., insomnia) in a specific diagnostic group (e.g., depression). However, real-life sleep and circadian problems are not so neatly categorized, particularly in SMI. Hence, the investigators developed the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to treat a wide range of sleep and circadian problems experienced in SMI.
With NIMH support, including a study in CMHCs, the investigators established that TranS-C engages the target. Yet gaps remain: 1) Thus far, the TranS-C providers have been employed, trained and supervised by the university. The investigators will determine if TranS-C can be effectively delivered by providers within CMHCs. 2) The investigators will test a version of TranS-C that has been adapted to improve the fit and to address potential barriers to scaling TranS-C. The rigorous adaptation process used theory, data and stakeholder inputs. 3) The investigators will study ad hoc adaptations made by providers to TranS-C. 4) The investigators include two stages; namely, the Implementation Phase (2 years) and the Sustainment Phase (1 year). The latter responds to urgent calls to study the sustainability of EBTs.
Guided by the Replicating Effective Programs (REP) framework, in this Hybrid Type 1, 4-year study, 8 CMHC clinic sites will be cluster randomized to either Standard or Adapted TranS-C. Then, within each CMHC site, patients will be randomized to immediate TranS-C or to Usual Care followed by Delayed Treatment (UC-DT). A total of 104 providers and 624 patients. Patients will be assessed pre, mid and post-treatment and at 6 months follow-up. UC Berkeley will co-ordinate the research, facilitate implementation, collect data etc. Providers within an established network of CMHCs will implement TranS-C. 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. SA2 is to evaluate the fit, to the CMHC context, of Standard vs. Adapted TranS-C via provider ratings of acceptability, appropriateness and feasibility. SA3 will examine if better fit, operationalized via provider ratings of acceptability, mediates the relationship between treatment condition and patient outcome. This research will determine if sleep and circadian problems can be effectively addressed in SMI in CMHC settings, test two variations of TranS-C that each have unique advantages and focus on community providers and typical community patients.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Standard 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. |
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.
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| Experimental: Adapted 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. |
Behavioral: 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.
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| Active Comparator: UC-DT 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). |
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).
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Outcome Measures
Primary Outcome Measures
- Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance [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 using a self-report questionnaire. The minimum value is 8. The maximum value is 40. Higher scores mean more sleep disturbance (worse outcome).
- Provider-level outcome: Acceptability Intervention Measure [Once at baseline, at mid-treatment, which is 2 or 4 weeks after the beginning of treatment for each client, once at 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.
Secondary Outcome Measures
- 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: 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: 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.
- 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: Intervention Appropriateness Measure [Once at baseline, at mid-treatment, which is 2 or 4 weeks after the beginning of treatment for each client, once at 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
- Provider-level outcome: Feasibility of Intervention Measure [Once at baseline, at mid-treatment, which is 2 or 4 weeks after the beginning of treatment for each client, once at 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.
Other Outcome Measures
- Patient-level outcome: Alcohol Intake [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.
- Patient-level outcome: Substances Intake [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.
- Patient-level outcome: Tobacco Intake [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.
- Patient-level outcome: Caffeine Intake [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.
- Patient-level outcome: Suicidal Ideation Questionnaire [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.
- Patient-level outcome: Credibility Expectancy Questionnaire [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.
- Patient-level outcome: Utilization Questionnaire [Once at post-treatment, which is 6 or 10 weeks after the beginning of treatment, and at 6-month follow-up.]
Measures the elements of TranS-C that are most used.
- Patient-level outcome: Duke Checklist of Medical Conditions & Symptoms [Once at baseline.]
Assesses physical illness or neurological degenerative disease directly related to the onset and course of the sleep and circadian dysfunction.
- Provider-level outcome: Checklist of Modules Delivered [Once at each session between patient and provider.]
Assesses which treatment modules were delivered by the providers using a self-report checklist.
- Provider-level outcome: Adaptations to Evidence-Based Practices Scale [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.
- Provider-level outcome: Semi-structured interview [20% of randomly selected providers and leadership once during the implementation phase and once during the sustainment phase.]
Assesses perceptions of TranS-C.
- Provider-level outcome: Use of TranS-C Assessment [Twice during the 1 year sustainment phase (at 6 months and 12 months).]
Assesses if providers continue to use TranS-C in a self-report questionnaire.
- Provider-level outcome: Session attendance and duration log [Once at each session between patient and provider.]
Collect session date and duration (length of session).
Eligibility Criteria
Criteria
Inclusion Criteria:
The inclusion criteria for CMHCs are:
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Publicly funded adult mental health outpatient services
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Support from CMHC leadership
The inclusion criteria for CMHC providers are:
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Employed to deliver clinical services within the CMHC
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Interest in learning and delivering TranS-C
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Volunteer to participate and formally consent to participate
Consumers must meet the following inclusion criteria:
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Aged 18 years and older
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Meet criteria for a SMI as documented in the CMHC medical record
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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
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Receiving the standard of care for the SMI within the CMHC and consent to regular communications with the consumer's mental health providers
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Consent to access their medical record and participate in assessments
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Guaranteed place to sleep for at least 2 months that is not a shelter
Exclusion Criteria:
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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
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Presence of substance abuse/dependence only if it makes participation in the study unfeasible
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Current active intent or plan to commit suicide (those with suicidal ideation are eligible) or homicide risk
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Night shift work >2 nights per week in the past 3 months
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Pregnancy or breast-feeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Contra Costa Health, Housing, and Homeless Services Division | Concord | California | United States | 94520 |
| 2 | Solano County Department of Health & Social Services, Behavioral Health Services | Fairfield | California | United States | 94533 |
| 3 | Santa Barbara County Department of Behavioral Wellness | Goleta | California | United States | 93110 |
| 4 | Alameda County Behavioral Health Care Services | Oakland | California | United States | 94606 |
| 5 | Placer County Health and Human Services, Adult System of Care | Roseville | California | United States | 95678 |
| 6 | Monterey County Behavioral Health | Salinas | California | United States | 93906 |
| 7 | Bay Area Community Health | San Jose | California | United States | 95148 |
| 8 | County of Santa Cruz Behavioral Health Services for Children and Adults | Santa Cruz | California | United States | 95060 |
Sponsors and Collaborators
- University of California, Berkeley
Investigators
- Principal Investigator: Allison Harvey, PhD, University of California, Berkeley
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R01MH120147