An Efficient Treatment for Posttraumatic Injury for Firefighters

NCT05950035 | Completed

• 1 other identifier: MCA0006AGG
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder; Insomnia; Nightmare

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Trauma-Related Nightmare Survey (TRNS)

  Change from baseline through 3 months post treatment

• Self-Assessment of Sleep (SASS)

  Change from baseline through 3 months post treatment

• Sleep Diary and Nightmare Log

  Change from baseline through post treatment (~4 weeks post baseline)

• Patient Health Questionnaire-9 (PHQ-9)

  Change from baseline through 3 months post treatment

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

  Change from baseline through 3 months post treatment

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

Will begin treatment within 2 weeks of randomization.

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

Delayed Intervention

ACTIVE COMPARATOR

Will be scheduled to begin treatment within 4-6 weeks of randomization.

Behavioral: Waitlist

Interventions

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.

Immediate Intervention

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.

Immediate Intervention

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.

Immediate Intervention

Waitlist BEHAVIORAL

Waitlist for delayed intervention.

Delayed Intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

NDRI_USA

Kansas City, Missouri, 66224, United States

Location

Related Publications (1)

• McLean CP, Janke S, Pruiksma KE, Taylor DJ, Sloan DM, Dietch JR, Fredman SJ, Sutherland C, Hollerbach B, Thompson SM, Tse D, Nagy S, Malek N, Haddock CK. A pilot feasibility randomized clinical trial of a culturally adapted accelerated group treatment for posttraumatic stress, insomnia, and nightmares in firefighters. Psychol Trauma. 2026 Jan 19. doi: 10.1037/tra0002090. Online ahead of print.

  PMID: 41556892 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy; Waiting Lists

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Appointments and Schedules; Organization and Administration; Health Services Administration

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: June 5, 2023
• First Posted: July 18, 2023
• Study Start: December 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)