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

• ClinicalTrials.gov Identifier: NCT05956678
• Recruitment Status: Completed
• First Posted: July 21, 2023
• Last Update Posted: May 10, 2024
• Sponsor: University of California, Berkeley
• Information provided by (Responsible Party): University of California, Berkeley

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sleep Wake Disorders; Circadian Rhythm Disorders	Behavioral: Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C); Behavioral: Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: CMHC providers are cluster-randomized to either Standard TranS-C or Adapted TranS-C by their CMHC of employment.
• Masking: Single (Participant)
• Masking Description: CMHC providers (i.e., the study participants) are blind to group allocation.
• Primary Purpose: Health Services Research
• Official Title: Implementing and Sustaining a Sleep Treatment to Improve Community Mental Health Part 3: Sustainment
• Actual Study Start Date: April 1, 2023
• Actual Primary Completion Date: April 1, 2024
• Actual Study Completion Date: April 1, 2024

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.
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.

Outcome Measures

Primary Outcome Measures :

1. Provider Report of Sustainment Scale [ Time Frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended. ]
   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.
2. Adaptations to Evidence-Based Practices Scale [ Time Frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended. ]
   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.
3. Penetration of TranS-C in Provider Caseload [ Time Frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended. ]
   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.
4. Outcomes and Effectiveness Scale [ Time Frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended. ]
   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.
5. Skills Subscale from the Determinants of Implementation Behavior Questionnaire [ Time Frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended. ]
   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.
6. Organizational Resources Subscale from the Implementation Potential Scales [ Time Frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended. ]
   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.

Secondary Outcome Measures :

1. TranS-C Delivery Relative to Pre-Sustainment [ Time Frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended. ]
   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.
2. TranS-C Provider Checklist [ Time Frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended. ]
   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.
3. Adaptations Checklist from the Framework for Reporting Adaptations and Modification - Expanded [ Time Frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended. ]
   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.
4. Use of Provider Manual and Patient Workbook [ Time Frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended. ]
   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).
5. Percentage of TranS-C Strategies Used [ Time Frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended. ]
   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).
6. TranS-C as Integrated or Standalone Treatment [ Time Frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended. ]
   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.
7. Number of Sessions with TranS-C [ Time Frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended. ]
   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).
8. Creation of Sleep Treatment Materials [ Time Frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended. ]
   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.
9. Administrator Support Subscale from the Implementation Potential Scales [ Time Frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended. ]
   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.
10. Knowledge of TranS-C [ Time Frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended. ]
    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.

Other Outcome Measures:

1. Acceptability of Intervention Measure [ Time Frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended. ]
   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.
2. Intervention Appropriateness Measure [ Time Frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended. ]
   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.
3. Feasibility of Intervention Measure [ Time Frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended. ]
   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.
4. Semi-structured interview with providers [ Time Frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended. ]
   Assesses providers' perceptions of TranS-C.
5. Adaptations in Response to Cultural Backgrounds of Patients [ Time Frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, California

Contra Costa Health, Housing, and Homeless Services Division

Concord, California, United States, 94520

Solano County Department of Health & Social Services, Behavioral Health Services

Fairfield, California, United States, 94533

Santa Barbara County Department of Behavioral Wellness

Goleta, California, United States, 93110

Kings County Behavioral Health

Hanford, California, United States, 93230

Lake County Behavioral Health Services

Lucerne, California, United States, 95458

Alameda County Behavioral Health Care Services

Oakland, California, United States, 94606

Placer County Health and Human Services, Adult System of Care

Roseville, California, United States, 95678

Monterey County Behavioral Health

Salinas, California, United States, 93906

Bay Area Community Health

San Jose, California, United States, 95148

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
• Principal Investigator: Laurel Sarfan, PhD; University of California, Berkeley

More Information

• Responsible Party: University of California, Berkeley
• ClinicalTrials.gov Identifier: NCT05956678
• Other Study ID Numbers: R01MH120147_P3; R01MH120147 ( U.S. NIH Grant/Contract )
• First Posted: July 21, 2023
• Last Update Posted: May 10, 2024
• Last Verified: May 2024

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, Berkeley:

Implementation; Sustainment; Evidence-based treatment; Community mental health

Additional relevant MeSH terms:

Chronobiology Disorders; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Mental Disorders