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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ once during the 1 year sustainment phase.

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).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, BerkeleyLead Sponsor

181 Previous Clinical Trials

720,580 Total Patients Enrolled

Allison Harvey, PhDPrincipal InvestigatorUniversity of California, Berkeley

9 Previous Clinical Trials

1,543 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the chief goal of this investigation?

"This clinical trial will be evaluated in a timeline that ranges from baseline to mid-treatment (2 or 4 weeks post initiation of treatment), post-treatment (6 or 10 weeks after onset) and 6 months follow up. The primary outcome is the acceptability of the intervention as assessed by providers, with secondary outcomes focusing on provider perceptions regarding appropriateness and feasibility, alongside patient self reporting information related to sleep impairments using PROMIS Sleep Related Impairment scale which has an minimum value of 16 and maximum score at 80; higher scores indicating more severe cases."

Answered by AI

How many healthcare institutions are participating in this research initiative?

"There are 8 different clinical trial sites currently running this medical study, including Solano County Department of Health & Social Services and Behavioral Health Services in Fairfield. Additionally Santa Barbara County Department of Behavioral Wellness in Goleta and Alameda County Behavioral Health Care Services in Oakland are also participating along with 4 other locations."

Answered by AI

How many participants are actively enrolled in this research project?

"Affirmative. Clinicaltrials.gov reflects that this research project, which was first publicized on the 8th of January 2020, is actively seeking test subjects. 576 participants need to be recruited from 8 distinct medical facilities."

Answered by AI

Is enrollment in this research endeavor open to participants at the present time?

"Affirmative. Clinical trials website data indicates that this trial, which was inaugurated on January 8th 2020, is currently recruiting patients. This study seeks to recruit 576 participants across 8 clinical sites."

Answered by AI

Who else is applying?

What site did they apply to?

Placer County Health and Human Services, Adult System of Care

What portion of applicants met pre-screening criteria?

Met criteria

Did not meet criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I have been complaining of sleep problems since my 30’s . I have oSA and tried 3 machines and 50 mask. When I got a ring doorbell for Christmas I decided to film myself. I flop all night like a fish out of water . I took to my sleep doctor saying I have RLS but he says it’s restlessness. Been on so many medications, but they work a few days then stop. I can’t afford to travel, but wish you could tell me who can help. I can’t find anything about restlessness during sleep with OSA. I am a teacher and also have ADHD or maybe I just got so sleep deprived it’s the only way I function??? Can you. Help?

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

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

2020. "Implementing and Sustaining a Sleep Treatment to Improve Community Mental Part 1: Implementation Health Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04154631.

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