Firefighters Accessing Care for Trauma: A Clinical Case Series of Distance NET for PTSD/I Symptoms
Primary Purpose
Post Traumatic Stress Disorder, Post Traumatic Stress Injury
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Distance-delivered NET
Sponsored by
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder
Eligibility Criteria
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).
Sites / Locations
- University of New Brunswick
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Narrative Exposure Therapy
Arm Description
Firefighters will receive distance-delivered NET administered by a paraprofessional.
Outcomes
Primary Outcome Measures
Change in PTSD/I symptoms
PTSD/I symptoms are measured with the PTSD Checklist - 5 (PCL-5)
Change in depressive symptoms
Depression symptoms will be measured using the Patient Health Questionnaire (PHQ-9)
Disability
Disability will be measured with the Sheehan Disability Scale
Secondary Outcome Measures
Anxiety Symptoms
Anxiety symptoms will be measured using the Generalized Anxiety Disorder - 7 item (GAD-7)
Physical Health
Physical health will be measured with the Patient Health Questionnaire Physical Symptoms (PHQ-15)
Health Service Use
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
Recruitment Rates
Recruitment rates will be tracked by research staff throughout the study
Intervention Adherence
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.
Coach Alliance
Coach alliance will be measured using the Working Alliance Inventory - Short Form Revised (WAI-SR)
Intervention Perceptions and Satisfaction
Intervention perceptions and satisfaction will be measured via open-ended questions administered through a post-intervention interview
Full Information
NCT ID
NCT04386330
First Posted
May 8, 2020
Last Updated
March 29, 2022
Sponsor
IWK Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR), University of New Brunswick
1. Study Identification
Unique Protocol Identification Number
NCT04386330
Brief Title
Firefighters Accessing Care for Trauma: A Clinical Case Series of Distance NET for PTSD/I Symptoms
Official Title
Firefighters Accessing Care for Trauma: A Clinical Case Series Testing the Efficacy of Distance-Delivered Narrative Exposure Therapy in Reducing PTSD/I Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 29, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IWK Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR), University of New Brunswick
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Post Traumatic Stress Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Narrative Exposure Therapy
Arm Type
Experimental
Arm Description
Firefighters will receive distance-delivered NET administered by a paraprofessional.
Intervention Type
Behavioral
Intervention Name(s)
Distance-delivered NET
Intervention Description
One-on-one intervention delivered by a paraprofessional; 12 weekly videoconference sessions at 90 minutes.
Primary Outcome Measure Information:
Title
Change in PTSD/I symptoms
Description
PTSD/I symptoms are measured with the PTSD Checklist - 5 (PCL-5)
Time Frame
Baseline, Immediately Post- intervention, 2 month follow up, 6 month follow up
Title
Change in depressive symptoms
Description
Depression symptoms will be measured using the Patient Health Questionnaire (PHQ-9)
Time Frame
Baseline,Immediately Post-intervention, 2 month follow up, 6 month follow up
Title
Disability
Description
Disability will be measured with the Sheehan Disability Scale
Time Frame
Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
Secondary Outcome Measure Information:
Title
Anxiety Symptoms
Description
Anxiety symptoms will be measured using the Generalized Anxiety Disorder - 7 item (GAD-7)
Time Frame
Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
Title
Physical Health
Description
Physical health will be measured with the Patient Health Questionnaire Physical Symptoms (PHQ-15)
Time Frame
Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
Title
Health Service Use
Description
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
Time Frame
Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
Title
Recruitment Rates
Description
Recruitment rates will be tracked by research staff throughout the study
Time Frame
Baseline
Title
Intervention Adherence
Description
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.
Time Frame
Immediately Post-Intervention
Title
Coach Alliance
Description
Coach alliance will be measured using the Working Alliance Inventory - Short Form Revised (WAI-SR)
Time Frame
Immediately Post-Intervention
Title
Intervention Perceptions and Satisfaction
Description
Intervention perceptions and satisfaction will be measured via open-ended questions administered through a post-intervention interview
Time Frame
Immediately Post-Intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
University of New Brunswick
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B5A3
Country
Canada
12. IPD Sharing Statement
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Firefighters Accessing Care for Trauma: A Clinical Case Series of Distance NET for PTSD/I Symptoms
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