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NCT Number: NCT07069517

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

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.

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Key information

Conditions

Insomnia Combat Disorders Dyssomnias Mental Disorders Nervous System Diseases Nightmares PTSD - Post Traumatic Stress Disorder Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The aims of the study are:

  • Determine the efficacy of accelerated cognitive behavioral therapy for insomnia and nightmares (CBTi+n) integrated with Written Exposure Therapy (WET) for PTSD for improving insomnia symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD.
  • Determine the efficacy of accelerated CBTi+n integrated with WET for improving nightmare symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD.

Exploratory Aim: Determine the efficacy of accelerated CBTi+n integrated with WET for improving PTSD symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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.

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 (WET)

Behavioral

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

Sleep Hygiene

Behavioral

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

Primary outcomes

  1. Posttraumatic Stress Disorder Checklist (PCL-5)

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

    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).

  2. Insomnia Severity Index (ISI)

    Time frame: Change from baseline through 3 and 6 month follow up

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

  3. Nightmare Disorders Index

    Time frame: Change from baseline through 3 and 6 month assessments

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

Secondary outcomes

  1. Clinician Administered PTSD Scale (CAPS-5)

    Time frame: Change from baseline to 1-month follow-up assessment

    The CAPS-5 is a structured clinical interview that assesses the presence and severity of PTSD symptoms. Total scores range from 0-80 (higher scores indicate greater PTSD severity).

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

    Time frame: Change from baseline to 1-month follow-up assessment

    The SCISD-R is a semi-structured interview designed to obtain a sleep history and screen for certain sleep disorders and diagnose others, including insomnia, hypersomnia, circadian rhythm sleep-wake disorders, sleep-disordered breathing, and parasomnias.

  3. Generalized Anxiety Disorder Screener (GAD-7)

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

    GAD-7 is a 7-item measure that assesses generalized anxiety symptomology. Total scores range from 0-21 (higher scores indicate greater anxiety).

  4. Trauma-Related Nightmare Survey (TRNS)

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

    The TRNS assesses nightmare frequency, disturbance, and characteristics

  5. Depressive Symptoms Index-Suicidality Subscale (DSI-SS)

    Time frame: Change from baseline through 3 and 6 month follow up assessment

    The DSI-SS is a self-report measure of suicidal ideation, plans, perceived control over ideation, and impulses for suicide. Total scores range from 0-12 (higher scores indicate greater suicidality).

  6. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Change from baseline through 3 and 6 follow-up assessment

    The PHQ-9 assess the severity of affective and somatic symptoms related to depression; items correspond to the diagnostic criteria for major depression disorder. Total scores range from 0-27 (higher scores indicate greater depressive symptom severity).

  7. Brief Inventory of Psychosocial Functioning (B-IPF)

    Time frame: Change from baseline through 3 and 6 month follow up

    B-IPF is a 7-item measure of functioning in seven life domains: romantic relationship, relationship with children, family relationships, friendships and socializing, work, training and education, and activities of daily living. Total scores range from 0-42 (higher scores indicate greater functional impairment).

Other outcomes

  1. Neuropsychological battery

    Time frame: Change from second baseline to 1-month follow-up assessment

    The Neuropsychological battery draws from the from NIH toolbox Cognitive Battery and is comprised of the following tasks: Picture Vocab, Face Name Associative Memory Exam Test, Flanker Task, Oral Symbol Digit, Picture Sequence, Pattern Comparison, Dimensional Change, and Face Name Associative Memory Exam Delay.

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

    Time frame: Change from baseline through 3 and 6 month follow up assessments

    The SASS-Y measures average bedtime, sleep time, sleep onset latency, number of awakenings, wake time after sleep onset, wake time, out of bedtime and sleep quality.

  3. Sleep Diary and Nightmare Log

    Time frame: Change from second baseline through to the end of treatment

    The Sleep Diary and Nightmare Log assess daily subjective sleep patterns and to inform treatment recommendations.

  4. History of Head Injuries

    Time frame: Measured during baseline

    History of Head Injuries is a 3 question screener that assesses for head injury and altered consciousness.

  5. Health Questionnaire

    Time frame: Measured at baseline

    Health Questionnaire measures medical and mental health diagnoses that respondents have received, medical board and disability status, medications taken, and caffeine use

  6. Fitbit Inspire HR data will be downloaded through the Fitabase platform

    Time frame: Change from second baseline through 3 and 6 month follow-up

    Fitbit Inspire HR will measure heart rate, physical activity, and nighttime wakefulness.

  7. Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)

    Time frame: Change from baseline through 3 and 6 month follow up assessments

    Q-SF is a 16-item measure of life satisfaction and enjoyment in different areas of life over the past week. Total scores range from 14-70 (higher scores indicate greater enjoyment and satisfaction with life).

  8. Credibility and Expectancy Questionnaire (CEQ)

    Time frame: Change from pre-workshop through 1 month follow up

    The CEQ is a 6-item measure that was designed to assess treatment expectancy and rationale credibility for use in clinical outcomes studies

Study contacts

Contact information is provided by the study sponsor or research team.

Carmen McLean, PhD

CONTACT

[email protected]

650-614-9997

Sponsors and collaborators

Lead sponsor

Palo Alto Veterans Institute for Research

Other

Collaborators

  • NDRI-USA, Inc.
  • The University of Texas Health Science Center at San Antonio
  • University of Arizona

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 16, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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