An Efficient Treatment for Posttraumatic Injury for Firefighters

Not Applicable

Completed

• Conditions: Insomnia; Posttraumatic Stress Disorder; Nightmare

• Registration Number: NCT05950035
• Lead Sponsor: Palo Alto Veterans Institute for Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-07-14
• Study First Posted: 2023-07-18
• Study Start: 2023-12-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Structured Clinical Interview for DSM-5 Sleep Disorders- Revised (SCISD-R)	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.
Insomnia Severity Index (ISI)	Change from baseline through 3 months post treatment	The ISI assesses perceived severity of insomnia.
Nightmare Disorders Index	Change from baseline through 3 months post treatment	The NDI is a self-report assessment of nightmare disorder.
Clinician Administered PTSD Scale (CAPS-5)	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.
Posttraumatic Stress Disorder Checklist (PCL-5)	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 Outcome Measures

Name	Time	Method
Sleep Diary and Nightmare Log	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.
Trauma-Related Nightmare Survey (TRNS)	Change from baseline through 3 months post treatment	The TRNS assesses nightmare frequency, disturbance, and characteristics.
Patient Health Questionnaire-9 (PHQ-9)	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.
Depressive Symptoms Index-Suicidality Subscale (DSI-SS)	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.
Self-Assessment of Sleep (SASS)	Change from baseline through 3 months post treatment	The SASS is a brief assessment of self-reported sleep quantity and sleep quality.
Net Prompter Score	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.

Trial Locations

Locations (1)

NDRI_USA; 🇺🇸 Kansas City, Missouri, United States