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

NCT05956678 | Completed DMC

• 2 other identifiers: R01MH120147_P3R01MH120147
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 10

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.

Conditions

Sleep Wake Disorders; Circadian Rhythm Disorders

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (10)

• TranS-C Delivery Relative to Pre-Sustainment

  Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.

• TranS-C Provider Checklist

  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

  Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.

• Use of Provider Manual and Patient Workbook

  Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.

• Percentage of TranS-C Strategies Used

  Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.

Other Outcomes (5)

• Acceptability of Intervention Measure

  Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.

• Intervention Appropriateness Measure

  Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.

• Feasibility of Intervention Measure

  Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.

Study Arms (2)

Standard TranS-C

EXPERIMENTAL

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)

Adapted TranS-C

EXPERIMENTAL

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)

Interventions

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.

Standard TranS-C

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.

Adapted TranS-C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Publicly funded adult mental health outpatient services
• Support from CMHC leadership
• 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• University of California, Berkeley: lead

Study Sites (10)

Contra Costa Health, Housing, and Homeless Services Division

Concord, California, 94520, United States

Location

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

Fairfield, California, 94533, United States

Location

Santa Barbara County Department of Behavioral Wellness

Goleta, California, 93110, United States

Location

Kings County Behavioral Health

Hanford, California, 93230, United States

Location

Lake County Behavioral Health Services

Lucerne, California, 95458, United States

Location

Alameda County Behavioral Health Care Services

Oakland, California, 94606, United States

Location

Placer County Health and Human Services, Adult System of Care

Roseville, California, 95678, United States

Location

Monterey County Behavioral Health

Salinas, California, 93906, United States

Location

Bay Area Community Health

San Jose, California, 95148, United States

Location

County of Santa Cruz Behavioral Health Services for Children and Adults

Santa Cruz, California, 95060, United States

Location

Related Publications (2)

• Sarfan LD, Agnew ER, Diaz M, Cogan A, Spencer JM, Esteva Hache R, Wiltsey Stirman S, Lewis CC, Kilbourne AM, Harvey AG. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 3: study protocol to evaluate sustainment in a hybrid type 2 effectiveness-implementation cluster-randomized trial. Trials. 2024 Jan 15;25(1):54. doi: 10.1186/s13063-023-07900-1.

  PMID: 38225677 DERIVED

• Sarfan LD, Agnew ER, Diaz M, Cogan A, Spencer JM, Hache RE, Stirman SW, Lewis CC, Kilbourne AM, Harvey A. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 3: Study protocol to evaluate sustainment in a hybrid type 2 effectiveness-implementation cluster-randomized trial. Res Sq [Preprint]. 2023 Oct 30:rs.3.rs-3328993. doi: 10.21203/rs.3.rs-3328993/v1.

  PMID: 37961426 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders; Chronobiology Disorders

Interventions

Sleep

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Allison Harvey, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

• Laurel Sarfan, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: CMHC providers (i.e., the study participants) are blind to group allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: CMHC providers are cluster-randomized to either Standard TranS-C or Adapted TranS-C by their CMHC of employment.

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 21, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

US (10)