An Efficient Treatment for Posttraumatic Injury for Firefighters
Study Details
Study Description
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:
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Is the behavioral intervention feasible, acceptable, and effective in reducing symptoms of posttraumatic stress, insomnia, and nightmares?
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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:
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Complete self-report and interview measures assessing posttraumatic stress disorder, insomnia (PTSD), and nightmares
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Attend an individual treatment orientation session
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Attend a 4-day (~3 hours per day over 4 consecutive days) group treatment that integrates WET, CBT-I, and CBT-N
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Attend an individual booster session held approximately one week later
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
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| Active Comparator: Delayed Intervention Will be scheduled to begin treatment within 4-6 weeks of randomization. |
Behavioral: Waitlist
Waitlist for delayed intervention.
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Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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
- Trauma-Related Nightmare Survey (TRNS) [Change from baseline through 3 months post treatment]
The TRNS assesses nightmare frequency, disturbance, and characteristics.
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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18-65 years old
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Firefighter
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Able to speak and read English
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Clinically significant posttraumatic stress symptoms: CAPS-5 total score ≥ 25; ≥ 1 intrusion symptom; ≥ 1 avoidance symptom
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Clinically significant symptoms of insomnia: SCISD insomnia criteria are met; ISI ≥ 15
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Clinically significant symptoms of nightmare disorder: SCISD nightmare disorder criteria are met, nightmares ≥ 1 monthly.
Exclusion Criteria:
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Current suicide or homicide risk meriting crisis intervention
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Inability to speak and read English
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Inability to comprehend the baseline screening questionnaires
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Unwilling to remain abstinent from alcohol during treatment
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Serious mental health diagnosis such as bipolar disorder or psychosis.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NDRI_USA | Kansas City | Missouri | United States | 66224 |
Sponsors and Collaborators
- Palo Alto Veterans Institute for Research
- University of Arizona
- Oregon State University
- Boston University
- The University of Texas Health Science Center at San Antonio
- National Development and Research Institutes, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MCA0006AGG