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Search / Trial NCT07069517

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

Launched by PALO ALTO VETERANS INSTITUTE FOR RESEARCH · Jul 15, 2025

Trial Information

Current as of July 21, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new, faster way to treat people who have PTSD (Post-Traumatic Stress Disorder), insomnia (trouble sleeping), and frequent nightmares. The study will compare two types of treatments for sleep problems—one called cognitive-behavioral therapy, which helps change unhelpful thoughts and habits around sleep and nightmares, and the other called sleep hygiene, which focuses on healthy sleep habits. Both treatments will be combined with a therapy called Written Exposure Therapy, which helps people process traumatic memories. These therapies will be given in a short, intensive group program over five days, along with some individual sessions before and after the group treatment.

The study is looking for active-duty military members or veterans between 18 and 65 years old who have noticeable symptoms of PTSD, trouble sleeping, and at least one nightmare per month. Participants need to be able to read and speak English and agree not to start any new treatments for PTSD, sleep, or nightmares while in the study. If accepted, participants will be randomly assigned to one of the two treatment groups and participate in the five-day program. It’s important to know that people with serious mental health crises, ongoing therapy for PTSD or sleep issues, or certain other conditions (like pregnancy or shift work that interferes with sleep) will not be eligible. This study aims to find out if this accelerated treatment approach can help improve sleep and reduce PTSD symptoms more quickly and effectively.

Gender

ALL

Eligibility criteria

  • 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.

About Palo Alto Veterans Institute For Research

The Palo Alto Veterans Institute for Research (PAVIR) is a nonprofit organization dedicated to advancing medical research and improving healthcare outcomes for veterans. Located in Palo Alto, California, PAVIR collaborates with the Department of Veterans Affairs and leading academic institutions to conduct innovative clinical trials and research initiatives. The institute focuses on a wide range of health issues, including mental health, chronic diseases, and rehabilitation, aiming to translate findings into effective treatments and interventions. Committed to enhancing the quality of life for veterans, PAVIR fosters a multidisciplinary approach, leveraging cutting-edge technology and expertise to address the unique health challenges faced by this population.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported