An Efficient Treatment for Posttraumatic Injury for Firefighters
- Conditions
- InsomniaPosttraumatic Stress DisorderNightmare
- Interventions
- Behavioral: Written Exposure Therapy (WET)Behavioral: WaitlistBehavioral: Cognitive Behavioral Therapy for Insomnia (CBTi)Behavioral: Cognitive Behavioral Therapy for Nightmares (CBTn)
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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
- Arm && Interventions
Group Intervention Description Immediate Intervention Written Exposure Therapy (WET) Will begin treatment within 2 weeks of randomization. Immediate Intervention Cognitive Behavioral Therapy for Insomnia (CBTi) Will begin treatment within 2 weeks of randomization. Delayed Intervention Waitlist Will be scheduled to begin treatment within 4-6 weeks of randomization. Immediate Intervention Cognitive Behavioral Therapy for Nightmares (CBTn) Will begin treatment within 2 weeks of randomization.
- 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