Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-24 @ 6:42 PM
NCT ID:
NCT05805657
Eligibility Criteria:
Inclusion Criteria:
The inclusion criteria for the CMHC local trainers are:
* Employed in participating CMHCs
* Completed a Generation 1 TranS-C training (i.e., led by UC Berkeley expert trainers)
* Volunteer to participate and formally consent to participate
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05805657
Study Brief:
Protocol Section:
NCT05805657