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Behavioral Intervention

Sleep Health Intervention for PTSD

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
SCID Insomnia Disorder diagnosis, supported by ISI score >=10
Sleep-related functional impairment based on a WHODAS score >=32
Must not have
Current cognitive problems, active psychosis or mania, or other mental/cognitive conditions such as moderate to severe neurodegenerative disease that would render the participant unable to connect to videoconferencing platform, engage in remote psychotherapy, or communicate using the required VA secure email platform
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

"This trial will test a modified version of a sleep treatment for Veterans with PTSD who struggle with sleep problems."

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
Select...
I have been diagnosed with severe insomnia.
Select...
My sleep problems significantly affect my daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have severe mental health or cognitive issues that would stop me from using video calls or secure email.

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
1,647 Previous Clinical Trials
3,359,888 Total Patients Enrolled
Anne Richards, MD MPHPrincipal InvestigatorSan Francisco VA Medical Center, San Francisco, CA
~121 spots leftby Oct 2028
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