N/A
N=489
Implementing and Sustaining a Sleep Treatment to Improve Community Mental Part 1: Implementation Health Outcomes
Sleep Disorder · Circadian Dysregulation
Bottom Line
View on ClinicalTrials.gov: NCT04154631 ↗Enrolled (actual)
489
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance — 63.86; 62.10; 62.81; 62.80 T-score — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) (Behavioral); Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) (Behavioral); Usual Care Delayed Treatment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Berkeley
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance |
63.86; 62.10; 62.81; 62.80; 62.76; 62.80 | <0.001 sig |
| PRIMARY Provider-level Outcome: Acceptability Intervention Measure |
4.69; 4.70; 4.70; 4.60; 4.64; 4.67 | 0.77 |
| SECONDARY Patient-level Outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment |
62.78; 61.62; 60.79; 62.69; 62.06; 62.01 | <0.001 sig |
| SECONDARY Patient-level Outcome: Composite Sleep Health Score |
1.80; 2.11; 1.95; 2.14; 1.99; 2.07 | <0.001 sig |
| SECONDARY Patient-level Outcome: Sheehan Disability Scale |
12.26; 12.85; 12.24; 13.65; 12.63; 13.15 | <0.001 sig |
| SECONDARY Patient-level Outcome: The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure |
24.58; 24.12; 24.31; 24.11; 24.30; 24.18 | <0.001 sig |
| SECONDARY Provider-level Outcome: Intervention Appropriateness Measure |
4.62; 4.69; 4.70; 4.47; 4.59; 4.59 | 0.94 |
| SECONDARY Provider-level Outcome: Feasibility of Intervention Measure |
4.63; 4.61; 4.64; 4.51; 4.61; 4.61 | 0.34 |
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.
Eligibility Criteria
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/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
Data sourced from ClinicalTrials.gov (NCT04154631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.