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Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• 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.

Locations
United States
Texas
Fort Hood
RECRUITING
Kileen
Contact Information
Primary
Carmen McLean, PhD
carmen.mclean4@va.gov
650-614-9997
Time Frame
Start Date: 2025-12-02
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 160
Treatments
Active_comparator: Written exposure therapy and sleep hygiene for insomnia and nightmares
Experimental: Written exposure therapy and CBT for insomnia and nightmares
Sponsors
Collaborators: The University of Texas Health Science Center at San Antonio, University of Arizona, NDRI-USA, Inc.
Leads: Palo Alto Veterans Institute for Research

This content was sourced from clinicaltrials.gov