Clinical trial NCT04154631: Implementing and Sustaining a Sleep Treatment to Improve Community Mental Part 1: Implementation Health Outcomes
Official title: Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment to Improve Severe Mental Illness Outcomes in Community Mental Health Part 1: Implementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorder
Circadian Dysregulation
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 459
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 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.

Detailed description: An obstacle to the roll-out of evidence-based psychological treatments (EBPTs) 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 EBPT. 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 a Sustainment Phase (1 year), responding to urgent calls to study the sustainability of EBPTs.

This entry describes the Implementation Phase, the first of a three-phase hybrid type 2 effectiveness-implementation trial. In this phase, implementation and effectiveness outcomes of two versions of TranS-C (Standard and Adapted) are compared with CMHC providers who are trained by treatment experts.

Guided by the Replicating Effective Programs (REP) framework, at least 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 96 providers and 576 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.

Eligibility criteria: Inclusion Criteria:

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 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: 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, and 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: Semi-structured interview
timeFrame: 20% of randomly selected providers and leadership once during the implementation phase and once during the sustainment phase.
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: Gold Standard Supervision Elements
timeFrame: Up to 30 months
measure: Facilitator-level outcome: Implementation Log
timeFrame: Up to 30 months
measure: Facilitator-level outcome: Meeting Log
timeFrame: Up to 30 months
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: Goleta
country: United States
facility: Santa Barbara County Department of Behavioral Wellness
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: