Clinical trial NCT05950035: An Efficient Treatment for Posttraumatic Injury for Firefighters
Official title: An Efficient Treatment for Posttraumatic Injury for Firefighters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Insomnia
Nightmare
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
Collaborators: name: University of Arizona
name: Oregon State University
name: Boston University
name: The University of Texas Health Science Center at San Antonio
name: National Development and Research Institutes, Inc.
First posted: 2023-07-18
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinician Administered PTSD Scale (CAPS-5)
timeFrame: Change from baseline to post treatment (~4 weeks post baseline)
measure: Structured Clinical Interview for DSM-5 Sleep Disorders- Revised (SCISD-R)
timeFrame: Change from baseline to post treatment (~4 weeks post baseline)
measure: Insomnia Severity Index (ISI)
timeFrame: Change from baseline through 3 months post treatment
measure: Nightmare Disorders Index
timeFrame: Change from baseline through 3 months post treatment
measure: Posttraumatic Stress Disorder Checklist (PCL-5)
timeFrame: Change from baseline through 3 months post treatment
Secondary outcomes:
measure: Trauma-Related Nightmare Survey (TRNS)
timeFrame: Change from baseline through 3 months post treatment
measure: Self-Assessment of Sleep (SASS)
timeFrame: Change from baseline through 3 months post treatment
measure: Sleep Diary and Nightmare Log
timeFrame: Change from baseline through post treatment (~4 weeks post baseline)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change from baseline through 3 months post treatment
measure: Depressive Symptoms Index-Suicidality Subscale (DSI-SS)
timeFrame: Change from baseline through 3 months post treatment
measure: Net Prompter Score
timeFrame: Post treatment (~4 weeks post baseline)
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: NDRI_USA
state: Missouri
Study officials:
References: