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Behavioral Intervention

Arm 1: Experimental for Sleep Disorders

N/A
Waitlist Available
Led By Anne Richards, MD MPH
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* U.S. Military Veteran aged 18 and above engaged in VA primary and/or mental health care
* CAPS 5 PTSD diagnosis; or CAPS 5 score \>=25 in the absence of full criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0, week 5, post-treatment, 3-month follow-up, 6-month follow-up
Awards & highlights

Summary

Sleep disturbance is a major problem in Veterans with posttraumatic stress disorder (PTSD). This study will test a version of a sleep treatment that's been shown to be effective in the general population, with some changes to tailor it to the needs of Veterans with PTSD and sleep disturbance.

Who is the study for?
This trial is for Veterans with PTSD who struggle with sleep. It's designed to help those who haven't found relief from other treatments and are looking for a new approach specifically tailored to their needs.
What is being tested?
The study tests TranS-C, a modified sleep treatment proven effective in the general population, now adapted for Veterans with PTSD. Participants will also receive Sleep Psychoeducation as a control comparison.
What are the potential side effects?
Since this trial involves psychotherapy interventions rather than medication, side effects may include discomfort discussing traumatic events or changes in mood or behavior due to therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, week 5, post-treatment, 3-month follow-up, 6-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, week 5, post-treatment, 3-month follow-up, 6-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
World Health Organization Disability Assessment Schedule (WHODAS)
Secondary study objectives
Clinician-Administered PTSD Scale for DSM-4 Distressing Dream Score (CAPS-4 Nightmare Item)
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Insomnia Severity Index (ISI)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: ExperimentalExperimental Treatment1 Intervention
Participants receiving experimental TSC-PTSD treatment.
Group II: Arm 2: Active ControlActive Control1 Intervention
Participants receiving sleep psychoeducation control.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,642 Previous Clinical Trials
3,352,409 Total Patients Enrolled
Anne Richards, MD MPHPrincipal InvestigatorSan Francisco VA Medical Center, San Francisco, CA
~121 spots leftby Oct 2028
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