CompletedNot Applicable

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

United States489 participantsStarted 2020-01-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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 Exclusion Criteria: * 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/dependen…

What they're measuring

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

Timeframe: 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

Trial details

NCT IDNCT04154631

SponsorUniversity of California, Berkeley

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-19

Results submitted2025-04-25

View on ClinicalTrials.gov More Sleep Disorder trials