An Efficient Treatment for Posttraumatic Injury for Firefighters

NCT ID: NCT05950035

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-01-01

Brief Summary

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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

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Conditions

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Posttraumatic Stress Disorder Insomnia Nightmare

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Immediate Intervention

Will begin treatment within 2 weeks of randomization.

Group Type EXPERIMENTAL

Written Exposure Therapy (WET)

Intervention Type BEHAVIORAL

WET is a trauma-focused intervention in which individuals write about their worst traumatic experience following scripted instruction from the therapist.

Cognitive Behavioral Therapy for Insomnia (CBTi)

Intervention Type 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.

Cognitive Behavioral Therapy for Nightmares (CBTn)

Intervention Type 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.

Delayed Intervention

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

Group Type ACTIVE_COMPARATOR

Waitlist

Intervention Type BEHAVIORAL

Waitlist for delayed intervention.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Waitlist

Waitlist for delayed intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arizona

OTHER

Sponsor Role collaborator

Oregon State University

OTHER

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role collaborator

National Development and Research Institutes, Inc.

OTHER

Sponsor Role collaborator

Palo Alto Veterans Institute for Research

OTHER

Sponsor Role lead

Responsible Party

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Carmen McLean

Clinical Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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NDRI_USA

Kansas City, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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MCA0006AGG

Identifier Type: -

Identifier Source: org_study_id

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