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Behavioral Intervention

Sleep Treatment Training 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 a sleep treatment for those with serious mental illness, delivered by providers trained and supervised in-house via a 'Train the Trainer' approach. Two versions of the treatment will be tested.

Who is the study for?

This trial is for adults with serious mental illness (SMI) who are experiencing sleep or circadian disturbances. Participants must be receiving standard care for SMI, not work night shifts more than twice a week, and have stable housing. They cannot join if they have illnesses affecting sleep patterns, substance abuse issues that interfere with the study, or are pregnant/breastfeeding.Check my eligibility

What is being tested?

The study tests two versions of a sleep treatment in community mental health centers: 'Standard' TranS-C and an 'Adapted' version tailored for SMI patients. It uses a train-the-trainer model to see how well these treatments can be implemented by local trainers within the centers.See study design

What are the potential side effects?

Since this trial involves non-medical interventions focusing on training providers to treat sleep disorders, there may not be direct side effects like those seen with medications; however, changes in sleep patterns could potentially cause fatigue or mood alterations.

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.

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: Implementation Log

Facilitator-level outcome: Meeting Log

Patient-level outcome: Alcohol Intake

+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

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Who is running the clinical trial?

University of California, BerkeleyLead Sponsor

181 Previous Clinical Trials

720,966 Total Patients Enrolled

Allison Harvey, PhDPrincipal InvestigatorUniversity of California, Berkeley

9 Previous Clinical Trials

1,929 Total Patients Enrolled

Media Library

Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05805657 — 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: NCT05805657 — N/A

Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05805657 — N/A

Frequently Asked Questions

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

In what geographical regions is this clinical research being conducted?

"Nine clinical trial sites are currently enrolling participants for this study. This includes the Solano County Department of Health & Social Services, Behavioral Health Services in Fairfield, Kings County Behavioral Health in Hanford, and Lake County Behavioral Health Services in Lucerne; there are 6 other recruitment locations as well."

Answered by AI

Are any slots open for participants in this experiment?

"Affirmative. Clinicaltrials.gov indicates that the trial, which was first posted on December 14th 2020 and recently updated in March 27th 2023, is still searching for 190 participants across 9 different sites."

Answered by AI

How many participants are being assessed in this experiment?

"Correct. According to clinicaltrials.gov, this trial is actively recruiting patients with a start date of December 14th 2020 and its most recent update on March 27th 2023. 190 individuals need to be recruited from 9 sites across the country."

Answered by AI

What are the primary goals of this research endeavor?

"This medical trial seeks to measure the Acceptability Intervention Measure over a period of time, from baseline and mid-treatment (2 or 4 weeks following commencement) through post-treatment (6 or 10 weeks after starting treatment), up until 6 months after follow-up. Secondary outcomes include the Composite Sleep Health Score which aggregates assessments on Regularity, Satisfaction, Alertness, Timing Efficiency and Duration; Midpoint of Sleep Measure for gauging circadian functioning; as well as Sheehan Disability Scale used to determine functional impairment levels ranging from 0 - 30 points."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Implementing and Sustaining a Sleep Treatment to Improve Community Mental Health Part 2: Train-the-Trainer

2020. "Implementing and Sustaining a Sleep Treatment to Improve Community Mental Health Part 2: Train-the-Trainer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05805657.