RecruitingNot ApplicableNCT07069517

Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD

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

Sponsor

Palo Alto Veterans Institute for Research

Enrollment

160 participants

Start Date

Dec 2, 2025

Study Type

INTERVENTIONAL

Conditions

Insomnia PTSD - Post Traumatic Stress Disorder Nightmares

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

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.

Exclusion Criteria7

Current suicide or homicide risk meriting crisis intervention.
Inability to comprehend the baseline screening questionnaires.
Unwilling to remain abstinent from alcohol during therapy sessions.
Serious mental health symptoms, such as mania, psychosis, alcohol or substance use disorders warranting immediate clinical attention based on interviewer assessment and clinical judgement.
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).
Pregnancy, as determined by self-report, because pregnancy can adversely affect sleep outside of PTSD, insomnia, and nightmares.
Working duty shifts ending later than 21:00 or starting before 05:30 more than 2 times per month.

Interventions

BEHAVIORALCognitive-Behavioral Therapy for Insomnia (CBTi)

CBTi focuses on stimulus control, eliminating maladaptive coping habits, reducing arousal, and challenging maladaptive thoughts about sleep in an effort to reduce time to fall asleep and time awake during the night.

BEHAVIORALCognitive Behavioral Therapy for Nightmares (CBTn)

CBTn involves writing about a distressing or frequent nightmare, rewriting the narrative of the nightmare to target trauma-related themes, and reading the rescripted nightmare narrative.

BEHAVIORALWritten Exposure Therapy (WET)

WET is a trauma-focused intervention in which individuals write about their worst traumatic experience following scripted instruction from the therapist.

BEHAVIORALSleep Hygiene

Involves reviewing sleep diary data, sleep education, and reviewing and discussing sleep hygiene practices.