Skip to main content
OpenTrials
Completed

NCT Number: NCT05956678

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Contra Costa Health, Housing, and Homeless Services Division, Concord, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)

Behavioral

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.

Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)

Behavioral

The Adapted version was derived from Standard TranS-C. It was developed to improve the fit of the treatment with the CMHC context.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2023
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.