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

NCT04154631 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 489

Last updated 2025-10-27

Study results available
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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

Interventions

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.

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.

OTHER

Usual Care Delayed Treatment

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).

Sponsors & Collaborators

Principal Investigators

  • Allison Harvey, PhD · University of California, Berkeley

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-08
Primary Completion
2023-12-19
Completion
2023-12-19

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04154631 on ClinicalTrials.gov