Clinical trial NCT05956678: Implementing and Sustaining a Sleep Treatment to Improve Community Mental Health Part 3: Sustainment
Official title: Implementing and Sustaining a Sleep Treatment to Improve Community Mental Health Part 3: Sustainment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Wake Disorders
Circadian Rhythm Disorders
Keywords: Implementation
Sustainment
Evidence-based treatment
Community mental health
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: CMHC providers are cluster-randomized to either Standard TranS-C or Adapted TranS-C by their CMHC of employment.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Research on the sustainment of implemented evidence-based psychological treatments in routine practice settings, such as community mental health centers, is limited. The goal of this study is to test sustainment predictors, mechanisms, and outcomes of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in community mental health centers after implementation efforts have ended. CMHC providers have been trained to deliver a "Standard" or "Adapted" version of TranS-C. Researchers will compare these two groups to evaluate differences--and possible mechanisms--with respect to sustainment outcomes.

Detailed description: More research on the sustainment of implemented evidence-based treatments in routine practice settings, such as community mental health centers (CMHCs), is needed. This study is the third and final phase-i.e., the Sustainment Phase-of a cluster-randomized controlled trial and focuses on CMHC providers' sustainment of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C). The Sustainment Phase seeks to build on the two earlier phases of the trial-the Implementation Phase (NCT04154631) and Train-the-Trainer Phase (NCT05805657)-during which TranS-C was adapted to fit the CMHC context, and ten CMHCs were cluster-randomized to implement Standard TranS-C or Adapted TranS-C via facilitation and train-the-trainer. Data collection for the Sustainment Phase will commence at least three months after implementation efforts in partnering CMHCs have ended. Note that in this study, sustainment is operationalized per Shediac-Rizkallah and Bone's framework (1998) and defined as continued (a) activities, (b) benefits, and (c) capacity of an intervention after implementation efforts have ended.

Aim 1: Report the sustainment outcomes of TranS-C after implementation support has ended.

Aim 2: Evaluate whether manipulating fit to context predicts sustainment outcomes. It is hypothesized that providers in Adapted TranS-C will report better sustainment outcomes (i.e., activities, benefits, and capacity) relative to Standard TranS-C.

Aim 3: Test whether provider perceptions of fit-operationalized as acceptability, appropriateness, and feasibility-mediate the relation between treatment condition (Standard versus Adapted TranS-C) and sustainment outcomes. It is hypothesized that Adapted TranS-C, compared to Standard TranS-C, will predict better sustainment outcomes (i.e., activities, benefits, and capacity) indirectly through better provider perceptions of fit.

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, able to deliver, or have delivered patient-facing services to patients within a CMHC
* Have attended a TranS-C training
* CMHC site of employment has been in a period of sustainment (i.e., implementation activities have ended) for at least three months
* volunteer to participate and formally consent to participate

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Provider Report of Sustainment Scale
timeFrame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
measure: Adaptations to Evidence-Based Practices Scale
timeFrame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
measure: Penetration of TranS-C in Provider Caseload
timeFrame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
measure: Outcomes and Effectiveness Scale
timeFrame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
measure: Skills Subscale from the Determinants of Implementation Behavior Questionnaire
timeFrame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
measure: Organizational Resources Subscale from the Implementation Potential Scales
timeFrame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Secondary outcomes:
measure: TranS-C Delivery Relative to Pre-Sustainment
timeFrame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
measure: TranS-C Provider Checklist
timeFrame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
measure: Adaptations Checklist from the Framework for Reporting Adaptations and Modification - Expanded
timeFrame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
measure: Use of Provider Manual and Patient Workbook
timeFrame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
measure: Percentage of TranS-C Strategies Used
timeFrame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
measure: TranS-C as Integrated or Standalone Treatment
timeFrame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
measure: Number of Sessions with TranS-C
timeFrame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
measure: Creation of Sleep Treatment Materials
timeFrame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
measure: Administrator Support Subscale from the Implementation Potential Scales
timeFrame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
measure: Knowledge of TranS-C
timeFrame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Other outcomes:
measure: Acceptability of Intervention Measure
timeFrame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
measure: Intervention Appropriateness Measure
timeFrame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
measure: Feasibility of Intervention Measure
timeFrame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
measure: Semi-structured interview with providers
timeFrame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
measure: Adaptations in Response to Cultural Backgrounds of Patients
timeFrame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
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
affiliation: University of California, Berkeley
name: Laurel Sarfan, PhD
role: PRINCIPAL_INVESTIGATOR
References: