- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04386330
Firefighters Accessing Care for Trauma: A Clinical Case Series of Distance NET for PTSD/I Symptoms
Firefighters Accessing Care for Trauma: A Clinical Case Series Testing the Efficacy of Distance-Delivered Narrative Exposure Therapy in Reducing PTSD/I Symptoms
Repeated exposure to trauma is an unavoidable part of the job for firefighters. Because of this, many Canadian firefighters screen positive for posttraumatic stress disorder/injury (PTSD/I). Unfortunately, like the general population, firefighters face many barriers to accessing mental health care. As a result, additional efforts are needed to increase timely access to effective PTSD/I services that are delivered in a way that reduces confidentiality and stigma risk.
This research study will test the preliminary efficacy and feasibility of distance-delivered Narrative Exposure Therapy (NET) delivered by a paraprofessional for firefighters with PTSD/I. NET is an evidence-based intervention approach developed specifically for PTSD/I resulting from repeated and continuous trauma. The intervention will be conducted via videoconference with a trained paraprofessional supervised by a clinical psychologist. The NET intervention will consist of 12 weekly 90-minute videoconference sessions.
Approximately 25 firefighters will be recruited to participate in the study. To test the efficacy of the intervention, participants will complete self-report questionnaires about PTSD/I and other mental health symptoms pre- and post-intervention as well as two- and six-months following intervention completion. Participants will also complete an open-ended interview at the end of the intervention to assess feasibility and participant satisfaction.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Brunswick
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Fredericton, New Brunswick, Canada, E3B5A3
- University of New Brunswick
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Participants must meet the following criteria to be eligible to move on to Consent
- Be at least 19 years of age
- Be able to understand spoken and written English at a Grade 8 level
- Be employed, or have been employed, by the fire service or be current or past fire service volunteers.
- Fulfill the criteria of full or subclinical PTSD/I according to the PCL-5.
- Have access to a computer with Internet.
- Live in Atlantic Canada or Ontario.
- Consent to be audio- (for consent and interview) and video-recorded (for intervention sessions).
Exclusion Criteria:
- Having a psychotropic medication change in the past three weeks.
- Are currently engaged in or have previously been engaged in exposure therapy for PTSD/I.
- Meet criteria for current mania or psychosis.
- Endorse suicidal ideation with plan or intent.
- Experience high levels of dissociation (as assessed by a score of >18.5 on the Shutdown Dissociation Scale).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Narrative Exposure Therapy
Firefighters will receive distance-delivered NET administered by a paraprofessional.
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One-on-one intervention delivered by a paraprofessional; 12 weekly videoconference sessions at 90 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in PTSD/I symptoms
Time Frame: Baseline, Immediately Post- intervention, 2 month follow up, 6 month follow up
|
PTSD/I symptoms are measured with the PTSD Checklist - 5 (PCL-5)
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Baseline, Immediately Post- intervention, 2 month follow up, 6 month follow up
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Change in depressive symptoms
Time Frame: Baseline,Immediately Post-intervention, 2 month follow up, 6 month follow up
|
Depression symptoms will be measured using the Patient Health Questionnaire (PHQ-9)
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Baseline,Immediately Post-intervention, 2 month follow up, 6 month follow up
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Disability
Time Frame: Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
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Disability will be measured with the Sheehan Disability Scale
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Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety Symptoms
Time Frame: Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
|
Anxiety symptoms will be measured using the Generalized Anxiety Disorder - 7 item (GAD-7)
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Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
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Physical Health
Time Frame: Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
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Physical health will be measured with the Patient Health Questionnaire Physical Symptoms (PHQ-15)
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Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
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Health Service Use
Time Frame: Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
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Health service use will be measured using a series of questions regarding participant's use of health services as well as frequency and intensity of service use
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Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
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Recruitment Rates
Time Frame: Baseline
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Recruitment rates will be tracked by research staff throughout the study
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Baseline
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Intervention Adherence
Time Frame: Immediately Post-Intervention
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Intervention adherence will be measured via attendance records of participants kept by their coach.
These attendance records will be used to measure the average number of completed sessions and the percentage of participants who did not complete the intervention.
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Immediately Post-Intervention
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Coach Alliance
Time Frame: Immediately Post-Intervention
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Coach alliance will be measured using the Working Alliance Inventory - Short Form Revised (WAI-SR)
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Immediately Post-Intervention
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Intervention Perceptions and Satisfaction
Time Frame: Immediately Post-Intervention
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Intervention perceptions and satisfaction will be measured via open-ended questions administered through a post-intervention interview
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Immediately Post-Intervention
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22081
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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