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

No Placebo-Only Group

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

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I have been diagnosed with severe insomnia.

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My sleep problems significantly affect my daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe mental health or cognitive issues that would stop me from using video calls or secure email.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0, week 5, post-treatment, 3-month follow-up, 6-month follow-up

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.