Accelerated 5-day program for insomnia, nightmares, and PTSD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-arm, individually randomized group-treatment trial that will enroll 160 DEERS-eligible active-duty service members or veterans. Participants are randomized to accelerated CBT for insomnia and nightmares combined with written exposure therapy versus a sleep hygiene control integrated with written exposure therapy, with both arms delivered in a five-day group format and supplemented by individual sessions before and after the group week. Primary aims focus on changes in insomnia severity and nightmare symptoms, with PTSD symptom change as an exploratory outcome. Standardized clinical instruments and symptom scales will be used to measure outcomes over follow-up.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fort Hood
  Kileen, Texas, United States Recruiting

Study contacts

• Study coordinator: Carmen McLean, PhD
• Email: carmen.mclean4@va.gov
• Phone: 650-614-9997

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Early restorative sleep treatment after an emergency department visit

  This trial will try virtual cognitive behavioral therapy for insomnia and nightmares soon after an assault-related emergency visit to see if it improves sleep and reduces PTSD symptoms.

  Recruiting Henry Ford Health System · Detroit, Michigan · NCT07121270

• COMP360 psilocybin for PTSD: see if it helps reduce symptoms with guided support

  This study tests COMP360 (a lab-made psilocybin) to see if it can help reduce PTSD symptoms in adults, with supervision from a trained team.

  Recruiting at 17 sites Phase 2/3 COMPASS Pathways · Tucson, Arizona and 16 other locations · NCT07570654

• SleepCogni for children with chronic insomnia

  A handheld SleepCogni device is tested to see if it helps kids aged 6–16 with chronic insomnia sleep better.

  Recruiting Sheffield Children's NHS Foundation Trust · Sheffield · NCT07926724

• Virtual Reality–Assisted Trauma-Focused CBT for PTSD

  A VR-assisted trauma-focused CBT approach is being tested to see if it helps adults with PTSD related to Northern Ireland–specific trauma.

  Recruiting Queen's University, Belfast · Newtownabbey, County Antrim · NCT07914634

• Music therapy after stroke

  This trial tests whether adding music therapy to standard care helps stroke patients sleep better and feel less anxious or depressed while in the hospital.

  Recruiting Universidad de Granada · Granada, Granada · NCT07899034

• ReVIVE for mTBI: Using VR and therapy to help adults with mild traumatic brain injury

  This study tests a virtual reality therapy combined with standard psychotherapy to see if it can reduce PTSD symptoms and improve executive function in adults with mild traumatic brain injury.

  Recruiting Phase 1 Johns Hopkins University · Baltimore, Maryland · NCT07890337

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.