Recruiting

CBT for Insomnia & Sleep Hygiene

Sponsor:

Palo Alto Veterans Institute for Research

Code:

NCT07069517

Conditions

Insomnia

PTSD - Post Traumatic Stress Disorder

Nightmares

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Cognitive-Behavioral Therapy for Insomnia (CBTi)

Cognitive Behavioral Therapy for Nightmares (CBTn)

Written Exposure Therapy (WET)

Sleep Hygiene

Study Details

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.

Conditions

Insomnia

PTSD - Post Traumatic Stress Disorder

Nightmares

Study ID

NCT07069517

Start date

Dec 2, 2025

Status verified date

Dec, 2025

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Written exposure therapy and sleep hygiene for insomnia and nightmares

experimental: Written exposure therapy and CBT for insomnia and nightmares

Interventions

Cognitive-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.

Cognitive 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.

Written Exposure Therapy (WET)

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

Sleep Hygiene

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

Primary outcome measure

  • Posttraumatic Stress Disorder Checklist (PCL-5) [ Time Frame: Change from baseline through 3 and 6 month follow-up assessment ]
  • Insomnia Severity Index (ISI) [ Time Frame: Change from baseline through 3 and 6 month follow up ]
  • Nightmare Disorders Index [ Time Frame: Change from baseline through 3 and 6 month assessments ]

Central Contacts and Locations

Central contacts

Carmen McLean, PhD

650-614-9997carmen.mclean4@va.gov

Locations

Fort Hood

Recruiting

Kileen, Texas, United States, 76544

Contacts

Bryce Williams

210-562-6700williamsB7@uthscsa.edu

More Information

Sponsor

Palo Alto Veterans Institute for Research

Last update posted

Dec 3, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Palo Alto Veterans Institute for Research on 2025-12-03.