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Completed

NCT Number: NCT05950035

An Efficient Treatment for Posttraumatic Injury for Firefighters

The goal of this two-arm pilot randomized controlled trial is to test a behavioral intervention that integrates three evidence-based cognitive behavioral interventions (written exposure therapy; WET, cognitive behavioral therapy for insomnia; CBT-I, and cognitive behavioral therapy for nightmares; CBT-N) among firefighters. The main questions it aims to answer are:

* Is the behavioral intervention feasible, acceptable, and effective in reducing symptoms of posttraumatic stress, insomnia, and nightmares? * What is the efficacy of efficient treatment vs. delayed treatment (2-4 week waitlist) in reducing symptoms of posttraumatic stress, insomnia, and nightmares?

We will beta test the intervention in 1-2 groups of 3-5 firefighters. Then we will randomize 50 participants to immediate or delayed (2-4 week waitlist) treatment. Consented participants will:

* Complete self-report and interview measures assessing posttraumatic stress disorder, insomnia (PTSD), and nightmares * Attend an individual treatment orientation session * Attend a 4-day (~3 hours per day over 4 consecutive days) group treatment that integrates WET, CBT-I, and CBT-N * Attend an individual booster session held approximately one week later * Complete self-report measures before, during, and after treatment, and at a 3-month follow up assessment and a clinical interview before and after treatment to assess program efficacy.

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Key information

Conditions

Posttraumatic Stress Disorder Dyssomnias Insomnia Mental Disorders Nervous System Diseases Nightmare Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress Disorders, Post-Traumatic 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

NDRI_USA

Kansas City, Missouri, 66224, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-65 years old
  • Firefighter
  • Able to speak and read English
  • Clinically significant posttraumatic stress symptoms: CAPS-5 total score ≥ 25; ≥ 1 intrusion symptom; ≥ 1 avoidance symptom
  • Clinically significant symptoms of insomnia: SCISD insomnia criteria are met; ISI ≥ 15
  • Clinically significant symptoms of nightmare disorder: SCISD nightmare disorder criteria are met, nightmares ≥ 1 monthly.

Exclusion criteria

  • Current suicide or homicide risk meriting crisis intervention
  • Inability to speak and read English
  • Inability to comprehend the baseline screening questionnaires
  • Unwilling to remain abstinent from alcohol during treatment
  • Serious mental health diagnosis such as bipolar disorder or psychosis.

Treatment and study plan

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.

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.

Waitlist

Behavioral

Waitlist for delayed intervention.

Primary outcomes

  1. Clinician Administered PTSD Scale (CAPS-5)

    Time frame: Change from baseline to post treatment (~4 weeks post baseline)

    The CAPS-5 is a structured clinical interview that assesses the presence and severity of PTSD symptoms.

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

    Time frame: Change from baseline to post treatment (~4 weeks post baseline)

    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. Insomnia Severity Index (ISI)

    Time frame: Change from baseline through 3 months post treatment

    The ISI assesses perceived severity of insomnia.

  4. Nightmare Disorders Index

    Time frame: Change from baseline through 3 months post treatment

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

  5. Posttraumatic Stress Disorder Checklist (PCL-5)

    Time frame: Change from baseline through 3 months post treatment

    Self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5.

Secondary outcomes

  1. Trauma-Related Nightmare Survey (TRNS)

    Time frame: Change from baseline through 3 months post treatment

    The TRNS assesses nightmare frequency, disturbance, and characteristics.

  2. Self-Assessment of Sleep (SASS)

    Time frame: Change from baseline through 3 months post treatment

    The SASS is a brief assessment of self-reported sleep quantity and sleep quality.

  3. Sleep Diary and Nightmare Log

    Time frame: Change from baseline through post treatment (~4 weeks post baseline)

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

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

    Time frame: Change from baseline through 3 months post treatment

    The PHQ-9 the severity of affective and somatic symptoms related to depression; items correspond to the diagnostic criteria for major depression disorder.

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

    Time frame: Change from baseline through 3 months post treatment

    The DSI-SS is a self-report measure of suicidal ideation, plans, perceived control over ideation, and impulses for suicide.

  6. Net Prompter Score

    Time frame: Post treatment (~4 weeks post baseline)

    The Net Prompter Score is a single item measures of treatment acceptability that asks respondents to rate the likelihood that they would recommend the efficient treatment to a friend or colleague on a scale from 0-10.

Sponsors and collaborators

Lead sponsor

Palo Alto Veterans Institute for Research

Other

Collaborators

  • Boston University
  • National Development and Research Institutes, Inc.
  • Oregon State University
  • The University of Texas Health Science Center at San Antonio
  • University of Arizona

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2023
Registry last updated
May 31, 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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