Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD

Recruiting now · Not applicable

Conditions studied: Insomnia, PTSD - Post Traumatic Stress Disorder, Nightmares

In brief

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.

Key facts

Study ID

NCT07069517

Run by

Palo Alto Veterans Institute for Research

People needed

160

Starts

2025-12-02

Expected to finish

2028-12-01

Last updated by the study team

2025-12-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Defense Enrollment Eligibility Reporting System (DEERS) eligible active-duty military personnel or veteran, 18-65 years old.
• Ability to speak and read English.
• Clinically significant PTSD symptoms (CAPS-5 > 25 with at least one Intrusion symptom and at least one Avoidance symptom).
• Clinically significant symptoms of insomnia disorder (Structured Clinical Interview for Sleep Disturbance DSM-5 (SCISD) Insomnia Criteria are met and Insomnia Severity Index (ISI) > 11).
• Nightmares > 1 monthly (as reported on the SCISD).
• Willing to refrain from new behavioral health or medication treatment for issues pertaining to PTSD, sleep, and nightmares during study participation.

You may not qualify if…

• Current suicide or homicide risk meriting crisis intervention.
• Inability to comprehend the baseline screening questionnaires.
• Unwilling to remain abstinent from alcohol during therapy sessions.
• Serious mental health symptoms, such as mania, psychosis, alcohol or substance use disorders warranting immediate clinical attention based on interviewer assessment and clinical judgement.
• Currently engaged in evidence-based psychotherapy for PTSD (e.g., Prolonged Exposure Therapy, Cognitive Processing Therapy, Written Exposure Therapy) or insomnia or nightmares (e.g., Cognitive Behavioral Therapy for Insomnia or Nightmares).
• Pregnancy, as determined by self-report, because pregnancy can adversely affect sleep outside of PTSD, insomnia, and nightmares.
• Working duty shifts ending later than 21:00 or starting before 05:30 more than 2 times per month.

Where it is running

• Fort Hood — Kileen, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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