Cognitive-Behavioral Therapy for PTSD, Insomnia, and Nightmares

Overseen By Carmen McLean, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Palo Alto Veterans Institute for Research

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is a two-arm individually randomized group treatment clinical trial evaluating behavioral therapies for insomnia, nightmares, and PTSD. The study will compare cognitive-behavioral therapy for insomnia and nightmares to sleep hygiene (Control), both integrated with Written Exposure Therapy for PTSD and delivered in an accelerated (i.e., 5-day) group treatment format, preceded and followed by individual treatment sessions. 160 participants will be randomized into one of two study conditions.

Are You a Good Fit for This Trial?

This trial is for active-duty military or veterans aged 18-65 with PTSD, experiencing frequent nightmares and significant insomnia. Participants must speak English, not start new treatments for these conditions during the study, and have a PTSD symptom score above a certain threshold.

Inclusion Criteria

I can speak and read English.

I have been diagnosed with severe insomnia.

I agree not to start new treatments for PTSD, sleep, or nightmares while in the study.

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive-Behavioral Therapy for Insomnia (CBTi)
• Cognitive Behavioral Therapy for Nightmares (CBTn)
• Written Exposure Therapy (WET)

Trial Overview The trial compares two behavioral therapies: cognitive-behavioral therapy (CBT) for both insomnia and nightmares versus sleep hygiene education. Both are combined with Written Exposure Therapy for PTSD in an accelerated group format over five days plus individual sessions.

How Is the Trial Designed?

Group I: Written exposure therapy and CBT for insomnia and nightmares Experimental Treatment 3 Interventions

Group II: Written exposure therapy and sleep hygiene for insomnia and nightmares Active Control 2 Interventions

Who Is Running the Clinical Trial?

Palo Alto Veterans Institute for Research

Lead Sponsor

Trials

58

Recruited

8,800+

University of Arizona

Collaborator

Trials

545

Recruited

161,000+

The University of Texas Health Science Center at San Antonio

Collaborator

Trials

486

Recruited

92,500+

NDRI-USA, Inc.

Collaborator

Trials

3

Recruited

1,400+