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Behavioral Intervention

Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for Sleep Disorders

N/A
Recruiting
Led By Allison Harvey, PhD
Research Sponsored by University of California, Berkeley
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once during the 1 year sustainment phase.
Awards & highlights

Study Summary

This trial will test an adapted sleep treatment to see if it improves sleep, functioning, and reduces symptoms in people with a severe mental illness.

Who is the study for?
This trial is for adults with severe mental illness (SMI) who self-report and have confirmed SMI, experience significant sleep or circadian disturbances, and are receiving standard care. They must not be in a shelter but have stable housing for at least 2 months, not work night shifts frequently, and aren't pregnant or breastfeeding. Substance abuse is only disqualifying if it impedes study participation.Check my eligibility
What is being tested?
The trial tests an adapted sleep treatment against the standard version to improve sleep quality in SMI patients at community mental health centers. It aims to see if these treatments can enhance overall functioning and reduce symptoms related to poor sleep.See study design
What are the potential side effects?
As this study focuses on non-pharmacological interventions for improving sleep patterns, side effects may include discomfort from changes in routine or potential stress from participating in therapy sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once during the 1 year sustainment phase.
This trial's timeline: 3 weeks for screening, Varies for treatment, and once during the 1 year sustainment phase. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
Provider-level outcome: Acceptability Intervention Measure
Secondary outcome measures
Patient-level outcome: Composite Sleep Health Score
Patient-level outcome: Midpoint of Sleep Measure
Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment
+4 more
Other outcome measures
Facilitator-level outcome: Gold Standard Supervision Elements
Facilitator-level outcome: Implementation Log
Facilitator-level outcome: Meeting Log
+16 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Standard TranS-CExperimental Treatment1 Intervention
Standard TranS-C is modularized and delivered across eight 50-minute, weekly, individual sessions. It is comprised of 4 cross-cutting interventions featured in every session; 4 core modules that apply to the vast majority of patients; and 7 optional modules used less commonly, depending on the presentation.
Group II: Adapted TranS-CExperimental Treatment1 Intervention
The process for developing Adapted TranS-C has been iterative and grounded in theory, data and stakeholder feedback. The core elements of the evidence-based theory of change underpinning TranS-C have been retained. Adapted TranS-C is delivered in four 20-minute, weekly, individual sessions.
Group III: UC-DTActive Control1 Intervention
Usual Care Delayed Treatment. Usual care in the partner CMHCs 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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)
2023
N/A
~130
Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)
2023
N/A
~130

Find a Location

Who is running the clinical trial?

University of California, BerkeleyLead Sponsor
181 Previous Clinical Trials
720,434 Total Patients Enrolled
Allison Harvey, PhDPrincipal InvestigatorUniversity of California, Berkeley
9 Previous Clinical Trials
1,519 Total Patients Enrolled

Media Library

Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04154631 — N/A
Sleep Disorders Research Study Groups: UC-DT, Standard TranS-C, Adapted TranS-C
Sleep Disorders Clinical Trial 2023: Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) Highlights & Side Effects. Trial Name: NCT04154631 — N/A
Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04154631 — N/A
~106 spots leftby Jun 2025
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