NCT07069517 Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD
| NCT ID | NCT07069517 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Palo Alto Veterans Institute for Research |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-12-02 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2025-12-02 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07069517 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07069517 currently recruiting?
Yes, NCT07069517 is actively recruiting participants. Contact the research team at carmen.mclean4@va.gov for enrollment information.
Where is the NCT07069517 trial being conducted?
This trial is being conducted at Kileen, United States.
Who is sponsoring the NCT07069517 clinical trial?
NCT07069517 is sponsored by Palo Alto Veterans Institute for Research. The trial plans to enroll 160 participants.
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