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NCT07069517NARecruiting

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

Palo Alto Veterans Institute for Research

Start Date

12/2/2025

Completion Date

12/1/2028

Summary

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.

Detailed Description

The aims of the study are: 1. Determine the efficacy of accelerated cognitive behavioral therapy for insomnia and nightmares (CBTi+n) integrated with Written Exposure Therapy (WET) for PTSD for improving insomnia symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD. 2. Determine the efficacy of accelerated CBTi+n integrated with WET for improving nightmare symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD. Exploratory Aim: Determine the efficacy of accelerated CBTi+n integrated with WET for improving PTSD symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD.

Eligibility Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: 1. Defense Enrollment Eligibility Reporting System (DEERS) eligible active-duty military personnel or veteran, 18-65 years old. 2. Ability to speak and read English. 3. Clinically significant PTSD symptoms (CAPS-5 \> 25 with at least one Intrusion symptom and at least one Avoidance symptom). 4. 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). 5. Nightmares \> 1 monthly (as reported on the SCISD). 6. Willing to refrain from new behavioral health or medication treatment for issues pertaining to PTSD, sleep, and nightmares during study participation. Exclusion Criteria: 1. Current suicide or homicide risk meriting crisis intervention. 2. Inability to comprehend the baseline screening questionnaires. 3. Unwilling to remain abstinent from alcohol during therapy sessions. 4. Serious mental health symptoms, such as mania, psychosis, alcohol or substance use disorders warranting immediate clinical attention based on interviewer assessment and clinical judgement. 5. 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). 6. Pregnancy, as determined by self-report, because pregnancy can adversely affect sleep outside of PTSD, insomnia, and nightmares. 7. Working duty shifts ending later than 21:00 or starting before 05:30 more than 2 times per month.

Interventions

BEHAVIORAL

Cognitive-Behavioral Therapy for Insomnia (CBTi)

BEHAVIORAL

Cognitive Behavioral Therapy for Nightmares (CBTn)

BEHAVIORAL

Written Exposure Therapy (WET)

BEHAVIORAL

Sleep Hygiene

Interested in This Trial?

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Conditions

InsomniaPTSD - Post Traumatic Stress DisorderNightmares

Locations

Fort Hood

Kileen, Texas 76544

United States