Implementing and Sustaining a Sleep Treatment to Improve Community Mental Part 1: Implementation Health Outcomes

NCT04154631 | Completed Results DMC

• 1 other identifier: R01MH120147
• Study Type: interventional
• Target: 489
• Locations: 1 country
• Sites: 10

Brief Summary

The sleep disturbance commonly experienced by individuals with a severe mental illness (SMI) reduces these individuals' capacity to function and contributes to key symptoms. This study will test the effects of a sleep treatment that has been adapted using theory, data and stakeholder inputs to improve the fit for SMI patients treated in community mental health centers (CMHCs), relative to the standard treatment. The investigators will also determine if the adapted and standard versions can improve sleep, improve functioning and reduce symptoms.

Conditions

Sleep Disorder; Circadian Dysregulation

Outcome Measures

Primary Outcomes (2)

• Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance

  Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale. The 8-item short version scale assesses perceived sleep problems (e.g., sleep quality, perception of sleep difficulties) over a 7-day period. Items are rated on a 5-point scale ranging from 1 (not at all) to 5 (very much). Raw scores are summed to produce a single score, resulting in a range from 8 to 40. Raw scores are converted to t-scores using treatment manuals. T-scores range from 30.5 to 77.5. A T-score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate worse sleep disturbance.

  Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS-C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C), and 6-month follow-up.

• Provider-level Outcome: Acceptability Intervention Measure

  Assesses provider perceptions of the acceptability of the treatment intervention using a self-report questionnaire. The 4-item scale is rated on a 5-point scale from 1 (completely disagree) to 5 (completely agree). A total score is calculated by averaging all four items. Total scores range from 1 to 5, with higher scores indicating greater perceptions of acceptability.

  Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS-C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C).

Secondary Outcomes (6)

• Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment

  Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS-C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C), and 6-month follow-up.

• Patient-level Outcome: Composite Sleep Health Score

  Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS-C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C), and 6-month follow-up.

• Patient-level Outcome: Sheehan Disability Scale

  Baseline, post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C), and 6-month follow-up.

• Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure

  Baseline, post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C), and 6-month follow-up.

• Provider-level Outcome: Intervention Appropriateness Measure

  Baseline, mid-treatment (2 weeks post-baseline for Adapted TranS-C and 4 weeks post-baseline for Standard TranS-C), post-treatment (4 weeks post-baseline for Adapted TranS-C and 8 weeks post-baseline for Standard TranS-C).

Other Outcomes (21)

• Patient-level Outcome: Midpoint of Sleep Measure

  Change from baseline, to mid-treatment, which is 2 or 4 weeks after the beginning of treatment, to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.

• Patient-level Outcome: Alcohol Intake

  Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.

• Patient-level Outcome: Substances Intake

  Change from baseline to post-treatment, which is 6 or 10 weeks after the beginning of treatment, and to 6-month follow-up.

Study Arms (3)

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.

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

UC-DT

ACTIVE COMPARATOR

Usual Care Delayed Treatment. Usual care in the partner CMHCs starts with a case manager who co-ordinates care and refers each client for a medication review and to various rehabilitation programs (e.g., health care, housing, nutrition, finding a job, peer monitoring).

Other: Usual Care Delayed Treatment

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

Usual Care Delayed Treatment OTHER

Usual care in the partner CMHCs typically starts with a case manager who co-ordinates care and refers each client for a medication review and to various rehabilitation programs (e.g., health care, housing, nutrition, finding a job, peer monitoring).

UC-DT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Publicly funded adult mental health outpatient services
• Support from CMHC leadership
• Employed or able to deliver client-facing services to CMHC clients
• Interest in learning and delivering TranS-C
• Volunteer to participate and formally consent to participate
• Aged 18 years and older
• Meet criteria for an SMI per self-report and confirmed by referring provider or administration of the Mini International Neuropsychiatric Interview (MINI) (DSM-5, Version 7.0.0) by a licensed clinical social worker on the research team
• Exhibit a sleep or circadian disturbance as determined by endorsing 4 "quite a bit" or 5 "very much" (or the equivalent for reverse scored items) on one or more PROMIS-SD questions
• Receiving the standard of care for the SMI and consent to regular communications between the research team and provider
• Consent to access their medical record and participate in assessments
• Guaranteed place to sleep for at least 2 months that is not a shelter

You may not qualify if:

• Presence of an active and progressive physical illness or neurological degenerative disease directly related to the onset and course of the sleep and circadian dysfunction, or making participation in the study unfeasible based on confirmation from the treating clinician and/or medical record
• Presence of substance abuse/dependence only if it makes participation in the study unfeasible
• Current active intent or plan to commit suicide (those with suicidal ideation are eligible) only if it makes participation in the study unfeasible, or homicide risk
• Night shift work \>2 nights per week in the past 3 months
• Pregnancy or breast-feeding

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 (5)

• Diaz M, Milner AE, Sarfan LD, Agnew ER, Oliver SM, Bol K, Harvey AG. Do Provider Characteristics and Perceptions Influence the Adoption and Implementation of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TSC) in Community Mental Health Centers? Community Ment Health J. 2025 Oct 31. doi: 10.1007/s10597-025-01552-y. Online ahead of print.

  PMID: 41171520 DERIVED

• Callaway CA, Varghese JM, Agnew ER, Sarfan LD, Harvey AG. An Examination of Training Quality and Provider Outcomes Across Two Generations of Train-the-Trainer. Adm Policy Ment Health. 2025 Sep;52(5):966-982. doi: 10.1007/s10488-025-01463-w. Epub 2025 Aug 21.

  PMID: 40839336 DERIVED

• Horwitz TB, Sarfan LD, Milner AE, Varghese J, Callaway CA, Harvey AG. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TSC) in Community Mental Health: Evaluating Self-Reported Psychiatric Disorders as a Predictor of Symptoms and Treatment Outcome. Res Sq [Preprint]. 2025 Aug 6:rs.3.rs-7189279. doi: 10.21203/rs.3.rs-7189279/v1.

  PMID: 40799745 DERIVED

• Harvey AG, Agnew ER, Esteva Hache R, Spencer JM, Diaz M, Ovalle Patino E, Milner A, Dong L, Kilbourne AM, Buysse DJ, Callaway CA, Sarfan LD. A randomized trial of adapted versus standard versions of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction implemented via facilitation and delivered by community mental health providers: improving the "fit" of psychological treatments by adapting to context. Implement Sci. 2025 Jul 9;20(1):32. doi: 10.1186/s13012-025-01440-9.

  PMID: 40634991 DERIVED

• Sarfan LD, Agnew ER, Diaz M, Dong L, Fisher K, Spencer JM, Howlett SA, Hache RE, Callaway CA, Kilbourne AM, Buysse DJ, Harvey AG. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 1: study protocol for a hybrid type 2 effectiveness-implementation cluster-randomized trial. Trials. 2023 Mar 17;24(1):198. doi: 10.1186/s13063-023-07148-9.

  PMID: 36927461 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

Results Point of Contact

• Title: Professor of Clinical Psychology
• Organization: Department of Psychology, University of California, Berkeley

aharvey@berkeley.edu

5104736490

Study Officials

• Allison Harvey, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessment team will be blind to group allocation at post-treatment and six-month follow-up
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: CMHC sites will be cluster randomized to either Standard TranS-C or Adapted TranS-C. Then within each CMHC site, patients will be randomized to either TranS-C or to Usual Care followed by Delayed Treatment (UC-DT).

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: November 6, 2019
• Study Start: January 8, 2020
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: October 27, 2025
• Results First Posted: July 4, 2025

Record last verified: 2025-10

Locations

US (10)