Implementing and Sustaining a Sleep Treatment to Improve Community Mental Part 1: Implementation Health Outcomes
Completed · Not applicable
Conditions studied: Sleep Disorder, Circadian Dysregulation
In brief
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.
Key facts
- Study ID
- NCT04154631
- Run by
- University of California, Berkeley
- People needed
- 489
- Starts
- 2020-01-08
- Expected to finish
- 2023-12-19
- Last updated by the study team
- 2025-10-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 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
- Consumers must meet the following inclusion criteria:
- 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
Where it is running
- Contra Costa Health, Housing, and Homeless Services Division — Concord, California, United States
- Solano County Department of Health & Social Services, Behavioral Health Services — Fairfield, California, United States
- Santa Barbara County Department of Behavioral Wellness — Goleta, California, United States
- Kings County Behavioral Health — Hanford, California, United States
- Lake County Behavioral Health Services — Lucerne, California, United States
- Alameda County Behavioral Health Care Services — Oakland, California, United States
- Placer County Health and Human Services, Adult System of Care — Roseville, California, United States
- Monterey County Behavioral Health — Salinas, California, United States
- Bay Area Community Health — San Jose, California, United States
- County of Santa Cruz Behavioral Health Services for Children and Adults — Santa Cruz, California, United States
Full record on ClinicalTrials.gov
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