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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Posttraumatic Stress Disorder; Nightmare
• Intervention / Treatment: Behavioral: Written Exposure Therapy (WET); Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTi); Behavioral: Cognitive Behavioral Therapy for Nightmares (CBTn); Behavioral: Waitlist

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 66224
      • NDRI_USA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Intervention; Will begin treatment within 2 weeks of randomization.	Behavioral: 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.; Behavioral: 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.; Behavioral: 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.
Active Comparator: Delayed Intervention; Will be scheduled to begin treatment within 4-6 weeks of randomization.	Behavioral: Waitlist; Waitlist for delayed intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Administered PTSD Scale (CAPS-5)	The CAPS-5 is a structured clinical interview that assesses the presence and severity of PTSD symptoms.	Change from baseline to post treatment (~4 weeks post baseline)
Structured Clinical Interview for DSM-5 Sleep Disorders- Revised (SCISD-R)	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.	Change from baseline to post treatment (~4 weeks post baseline)
Insomnia Severity Index (ISI)	The ISI assesses perceived severity of insomnia.	Change from baseline through 3 months post treatment
Nightmare Disorders Index	The NDI is a self-report assessment of nightmare disorder.	Change from baseline through 3 months post treatment
Posttraumatic Stress Disorder Checklist (PCL-5)	Self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5.	Change from baseline through 3 months post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trauma-Related Nightmare Survey (TRNS)	The TRNS assesses nightmare frequency, disturbance, and characteristics.	Change from baseline through 3 months post treatment
Self-Assessment of Sleep (SASS)	The SASS is a brief assessment of self-reported sleep quantity and sleep quality.	Change from baseline through 3 months post treatment
Sleep Diary and Nightmare Log	The Sleep Diary and Nightmare Log assess daily subjective sleep patterns and to inform treatment recommendations.	Change from baseline through post treatment (~4 weeks post baseline)
Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 the severity of affective and somatic symptoms related to depression; items correspond to the diagnostic criteria for major depression disorder.	Change from baseline through 3 months post treatment
Depressive Symptoms Index-Suicidality Subscale (DSI-SS)	The DSI-SS is a self-report measure of suicidal ideation, plans, perceived control over ideation, and impulses for suicide.	Change from baseline through 3 months post treatment
Net Prompter Score	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.	Post treatment (~4 weeks post baseline)

Collaborators and Investigators

• Sponsor: Palo Alto Veterans Institute for Research
• Collaborators: Boston University; The University of Texas Health Science Center at San Antonio; University of Arizona; National Development and Research Institutes, Inc.; Oregon State University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: MCA0006AGG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No