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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04386330
Other study ID # 22081
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 29, 2020
Est. completion date December 31, 2021

Study information

Verified date March 2022
Source IWK Health Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date December 31, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: Participants must meet the following criteria to be eligible to move on to Consent 1. Be at least 19 years of age 2. Be able to understand spoken and written English at a Grade 8 level 3. Be employed, or have been employed, by the fire service or be current or past fire service volunteers. 4. Fulfill the criteria of full or subclinical PTSD/I according to the PCL-5. 5. Have access to a computer with Internet. 6. Live in Atlantic Canada or Ontario. 7. Consent to be audio- (for consent and interview) and video-recorded (for intervention sessions). Exclusion Criteria: 1. Having a psychotropic medication change in the past three weeks. 2. Are currently engaged in or have previously been engaged in exposure therapy for PTSD/I. 3. Meet criteria for current mania or psychosis. 4. Endorse suicidal ideation with plan or intent. 5. Experience high levels of dissociation (as assessed by a score of >18.5 on the Shutdown Dissociation Scale).

Study Design


Intervention

Behavioral:
Distance-delivered NET
One-on-one intervention delivered by a paraprofessional; 12 weekly videoconference sessions at 90 minutes.

Locations

Country Name City State
Canada University of New Brunswick Fredericton New Brunswick

Sponsors (3)

Lead Sponsor Collaborator
IWK Health Centre Canadian Institutes of Health Research (CIHR), University of New Brunswick

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in PTSD/I symptoms PTSD/I symptoms are measured with the PTSD Checklist - 5 (PCL-5) Baseline, Immediately Post- intervention, 2 month follow up, 6 month follow up
Primary Change in depressive symptoms Depression symptoms will be measured using the Patient Health Questionnaire (PHQ-9) Baseline,Immediately Post-intervention, 2 month follow up, 6 month follow up
Primary Disability Disability will be measured with the Sheehan Disability Scale Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
Secondary Anxiety Symptoms Anxiety symptoms will be measured using the Generalized Anxiety Disorder - 7 item (GAD-7) Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
Secondary Physical Health Physical health will be measured with the Patient Health Questionnaire Physical Symptoms (PHQ-15) Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
Secondary 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 Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
Secondary Recruitment Rates Recruitment rates will be tracked by research staff throughout the study Baseline
Secondary 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. Immediately Post-Intervention
Secondary Coach Alliance Coach alliance will be measured using the Working Alliance Inventory - Short Form Revised (WAI-SR) Immediately Post-Intervention
Secondary Intervention Perceptions and Satisfaction Intervention perceptions and satisfaction will be measured via open-ended questions administered through a post-intervention interview Immediately Post-Intervention
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