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

NCT07069517 | Recruiting DMC

• 1 other identifier: MCA0010
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Posttraumatic Stress Disorder Checklist (PCL-5)

  Self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5. Total scores range from 0-80 (higher scores indicate greater PTSD severity).

  Change from baseline through 3 and 6 month follow-up assessment

• Insomnia Severity Index (ISI)

  The ISI assesses perceived severity of insomnia. Total scores range from 0-28 (higher scores indicate greater insomnia severity).

  Change from baseline through 3 and 6 month follow up

• Nightmare Disorders Index

  The NDI is a self-report assessment of nightmare disorder.

  Change from baseline through 3 and 6 month assessments

Secondary Outcomes (7)

• Clinician Administered PTSD Scale (CAPS-5)

  Change from baseline to 1-month follow-up assessment

• Structured Clinical Interview for DSM-5 Sleep Disorders- Revised (SCISD-R)

  Change from baseline to 1-month follow-up assessment

• Generalized Anxiety Disorder Screener (GAD-7)

  Change from baseline through 3 and 6 month follow-up assessment

• Trauma-Related Nightmare Survey (TRNS)

  Change from baseline through 3 and 6 month follow-up assessment

• Depressive Symptoms Index-Suicidality Subscale (DSI-SS)

  Change from baseline through 3 and 6 month follow up assessment

Other Outcomes (8)

• Neuropsychological battery

  Change from second baseline to 1-month follow-up assessment

• Split Week Self-Assessment of Sleep Survey (SASS-Y)

  Change from baseline through 3 and 6 month follow up assessments

• Sleep Diary and Nightmare Log

  Change from second baseline through to the end of treatment

Study Arms (2)

Written exposure therapy and sleep hygiene for insomnia and nightmares

ACTIVE COMPARATOR

Behavioral: Written Exposure Therapy (WET); Behavioral: Sleep Hygiene

Written exposure therapy and CBT for insomnia and nightmares

EXPERIMENTAL

Behavioral: Cognitive-Behavioral Therapy for Insomnia (CBTi); Behavioral: Cognitive Behavioral Therapy for Nightmares (CBTn); Behavioral: Written Exposure Therapy (WET)

Interventions

Cognitive-Behavioral Therapy for Insomnia (CBTi) BEHAVIORAL

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.

Written exposure therapy and CBT for insomnia and nightmares

Cognitive Behavioral Therapy for Nightmares (CBTn) BEHAVIORAL

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 and CBT for insomnia and nightmares

Written Exposure Therapy (WET) BEHAVIORAL

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

Written exposure therapy and CBT for insomnia and nightmares; Written exposure therapy and sleep hygiene for insomnia and nightmares

Sleep Hygiene BEHAVIORAL

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

Written exposure therapy and sleep hygiene for insomnia and nightmares

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: collaborator
• NDRI-USA, Inc.: collaborator
• Palo Alto Veterans Institute for Research: lead
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (1)

Fort Hood

Kileen, Texas, 76544, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Combat Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Carmen McLean, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: December 2, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)