Implementing and Sustaining a Sleep Treatment to Improve Community Mental Health Part 3: Sustainment

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.

Study Overview

• Status: Completed
• Conditions: Sleep Wake Disorders; Circadian Rhythm Disorders
• Intervention / Treatment: Behavioral: Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C); Behavioral: Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)

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.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Concord, California, United States, 94520
      • Contra Costa Health, Housing, and Homeless Services Division
    • Fairfield, California, United States, 94533
      • Solano County Department of Health & Social Services, Behavioral Health Services
    • Goleta, California, United States, 93110
      • Santa Barbara County Department of Behavioral Wellness
    • Hanford, California, United States, 93230
      • Kings County Behavioral Health
    • Lucerne, California, United States, 95458
      • Lake County Behavioral Health Services
    • Oakland, California, United States, 94606
      • Alameda County Behavioral Health Care Services
    • Roseville, California, United States, 95678
      • Placer County Health and Human Services, Adult System of Care
    • Salinas, California, United States, 93906
      • Monterey County Behavioral Health
    • San Jose, California, United States, 95148
      • Bay Area Community Health
    • Santa Cruz, California, United States, 95060
      • County of Santa Cruz Behavioral Health Services for Children and Adults

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.
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 and is comprised of 4 cross-cutting interventions featured in every session, 5 modules that apply to the vast majority of patients, and 1 optional module used less commonly, depending on the presentation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider Report of Sustainment Scale	Assesses providers' continued delivery of TranS-C via three self-report items that are rated on a scale from 0 (not at all) to 4 (to a very great extent) such that higher scores indicate more sustainment.	Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Adaptations to Evidence-Based Practices Scale	Assesses provider adaptations to TranS-C via six self-report items that are rated on scale from 1 (not at all) to 4 (very great extent) such that higher scores indicate greater use of adaptations.	Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Penetration of TranS-C in Provider Caseload	Two self-report items are used to derive the proportion of eligible patients with whom the provider has used TranS-C (i.e., number of eligible patients with whom provider has used TranS-C / the number of providers' patients with sleep problems), with higher scores indicating more penetration.	Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Outcomes and Effectiveness Scale	Assesses providers' perceptions of TranS-C's health benefits using five self-report items rated on a scale from 0 (to little or no extent) to 7 (to a very great extent) such that higher scores indicate more perceived benefits.	Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Skills Subscale from the Determinants of Implementation Behavior Questionnaire	Assesses providers perceptions of their skills to deliver TranS-C using three self-report items rated on a scale from 1 (strongly disagree) to 7 (strongly agree), where higher scores indicate perceptions of greater skills.	Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Organizational Resources Subscale from the Implementation Potential Scales	Assesses providers' perceptions of whether they have the resources, support, and time needed to deliver TranS-C. Three items are rated on a scale from 1 (strongly disagree) to 6 (strongly agree), where higher ratings indicate more perceived resources, support, and time.	Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TranS-C Delivery Relative to Pre-Sustainment	Uses one self-report item to assess whether providers are using TranS-C "more" (scored as 2), "about the same" (scored as 1), or "less" (scored as 0), relative to before the Sustainment Phase.	Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
TranS-C Provider Checklist	Assesses which TranS-C modules were delivered by providers during the Sustainment Phase using a self-report checklist containing all the modules for each condition. For each module, the checklist is scored such that 0 indicates that the provider did not deliver the module and 1 indicates that the provider delivered the module.	Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Adaptations Checklist from the Framework for Reporting Adaptations and Modification - Expanded	Assesses whether providers made any adaptations to TranS-C based on patient characteristics using a self-report checklist. Each patient characteristic on the checklist is scored such that 0 indicates that the provider did not make adaptations based on the characteristic and 1 indicates that the provider did make adaptations based on the characteristic.	Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Use of Provider Manual and Patient Workbook	Assesses the extent to which providers follow the TranS-C provider manual and patient workbook via one self-report item with the following scale: 0% (not at all) to 100% (always/completely).	Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Percentage of TranS-C Strategies Used	Assesses the percentage of TranS-C strategies used by providers on average when delivering TranS-C to patients via one self-report item with the following scale: 0% (no strategies) to 100% (all the strategies).	Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
TranS-C as Integrated or Standalone Treatment	Assesses whether providers deliver TranS-C as a standalone intervention using one self-report item with the following 4 categorically-coded response options: I always deliver the sleep treatment as a stand-alone intervention; I sometimes integrate the sleep treatment with other interventions or topics; I always integrate the sleep treatment with other interventions or topics; not applicable.	Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Number of Sessions with TranS-C	Assesses the number of sessions in which providers use TranS-C concepts for each patient, on average, via one self-report item that ranges from 0 (no sessions) to 50 (50 sessions).	Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Creation of Sleep Treatment Materials	Assesses whether providers have created their own sleep treatment materials via one self-report item with the following categorically-coded response options: no, not relevant, yes with option to describe materials.	Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Administrator Support Subscale from the Implementation Potential Scales	Assesses the extent to which providers perceive they have support from leadership and supervisors to deliver TranS-C. Three items are rated on a scale from 1 (strongly disagree) to 6 (strongly agree), where higher scores indicate more support.	Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Knowledge of TranS-C	Assesses the extent to which providers (1) understand the theory and concepts behind TranS-C and (2) have the knowledge to conduct TranS-C. Two items are rated on a scale from 0 (not at all) to 7 (extremely), where higher scores indicate more knowledge.	Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention Measure	Assesses provider perceptions of TranS-C's acceptability via four self-report items rated on a scale from 1 (completely disagree) to 5 (completely agree), with higher scores indicating greater acceptability.	Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Intervention Appropriateness Measure	Assesses provider perceptions of TranS-C's appropriateness via four self-report items rated on a scale from 1 (completely disagree) to 5 (completely agree), with higher scores indicating greater appropriateness.	Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Feasibility of Intervention Measure	Assesses provider perceptions of TranS-C's feasibility via four self-report items rated on a scale from 1 (completely disagree) to 5 (completely agree), with higher scores indicating greater feasibility.	Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Semi-structured interview with providers	Assesses providers' perceptions of TranS-C.	Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Adaptations in Response to Cultural Backgrounds of Patients	Assesses providers' adaptations to TranS-C based on cultural backgrounds of clients. Eight items are rated on a scale from 0 (not at all) to 5 (very great extent), with higher numbers indicating greater use of adaptations.	Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.

Collaborators and Investigators

• Sponsor: University of California, Berkeley
• Investigators: Principal Investigator: Laurel Sarfan, PhD, University of California, Berkeley; Principal Investigator: Allison Harvey, PhD, University of California, Berkeley

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Implementation; Community mental health; Sustainment; Evidence-based treatment
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Chronobiology Disorders
• Other Study ID Numbers: R01MH120147_P3; R01MH120147 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No