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

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

This 5-day group program combines cognitive-behavioral therapy for insomnia and nightmares with written exposure therapy to see if it reduces sleep problems and PTSD symptoms in active-duty military members and veterans who have insomnia, nightmares, and PTSD.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Palo Alto Veterans Institute for Research (Academic / other)
• Locations: 1 site (Kileen, Texas)
• Trial ID: NCT07069517 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are DEERS-eligible active-duty military members or veterans aged 18–65 with clinically significant PTSD (CAPS-5 > 25 with intrusion and avoidance), clinically significant insomnia (SCISD criteria and ISI > 11), at least monthly nightmares, and willingness to avoid new PTSD or sleep treatments during participation.

Not a fit: Patients with current suicide or homicide risk, unmanaged psychosis or mania, inability to abstain from alcohol during sessions, inability to complete baseline questionnaires, or who cannot attend in-person sessions at Fort Hood are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, this could provide a brief, scalable group program that quickly reduces insomnia and nightmares and may also lower PTSD symptoms for military personnel and veterans.

How similar studies have performed: CBT for insomnia, CBT for nightmares, and written exposure therapy each have prior evidence of benefit, but combining them into an accelerated 5-day group format is relatively novel with limited prior testing.

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.

Where this trial is running

Kileen, Texas

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

Study contacts

• Study coordinator: Carmen McLean, PhD

Conditions Insomnia; PTSD - Post Traumatic Stress Disorder; Nightmares