NCT04386330

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 29, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

May 8, 2020

Last Update Submit

March 29, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Disability

    Disability will be measured with the Sheehan Disability Scale

    Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up

Secondary Outcomes (7)

  • Anxiety Symptoms

    Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up

  • Physical Health

    Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up

  • Health Service Use

    Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up

  • Recruitment Rates

    Baseline

  • Intervention Adherence

    Immediately Post-Intervention

  • +2 more secondary outcomes

Study Arms (1)

Narrative Exposure Therapy

EXPERIMENTAL

Firefighters will receive distance-delivered NET administered by a paraprofessional.

Behavioral: Distance-delivered NET

Interventions

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

Narrative Exposure Therapy

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Brunswick

Fredericton, New Brunswick, E3B5A3, Canada

Location

Related Publications (1)

  • Olthuis JV, Kaltenbach E, Giberson E, Saryeddine T, Asmundson GJG, Carleton RN, Cramm H, Crombach A, Devlin J, Mack J, Lingley-Pottie P, Rao S, Sullivan M, Wozney L, McGrath PJ. Paraprofessional delivery of online narrative exposure therapy for firefighters. J Trauma Stress. 2023 Aug;36(4):772-784. doi: 10.1002/jts.22941. Epub 2023 Jun 8.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 8, 2020

First Posted

May 13, 2020

Study Start

June 29, 2020

Primary Completion

March 31, 2021

Study Completion

December 31, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations