Post Traumatic Stress DisorderNCT04386330
Firefighters Accessing Care for Trauma: A Clinical Case Series of Distance NET for PTSD/I Symptoms
A study testing Distance-delivered NET in people with Post Traumatic Stress Disorder and Post Traumatic Stress Injury, run by IWK Health Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder, Post Traumatic Stress Injury
- What is being tested?
- Distance-delivered NET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jun 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Distance-delivered NET
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distance-delivered NETBehavioural
One-on-one intervention delivered by a paraprofessional; 12 weekly videoconference sessions at 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Narrative Exposure Therapy | Experimental | Firefighters will receive distance-delivered NET administered by a paraprofessional. Receives: Behavioral: Distance-delivered NET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD/I symptoms
PTSD/I symptoms are measured with the PTSD Checklist - 5 (PCL-5)
Measured: 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)
Measured: Baseline,Immediately Post-intervention, 2 month follow up, 6 month follow up
Disability
Disability will be measured with the Sheehan Disability Scale
Measured: Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
Secondary outcomes (7)
Anxiety Symptoms
Anxiety symptoms will be measured using the Generalized Anxiety Disorder - 7 item (GAD-7)
Measured: Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
Physical Health
Physical health will be measured with the Patient Health Questionnaire Physical Symptoms (PHQ-15)
Measured: Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
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
Measured: Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
Recruitment Rates
Recruitment rates will be tracked by research staff throughout the study
Measured: Baseline
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.
Measured: Immediately Post-Intervention
Coach Alliance
Coach alliance will be measured using the Working Alliance Inventory - Short Form Revised (WAI-SR)
Measured: Immediately Post-Intervention
Intervention Perceptions and Satisfaction
Intervention perceptions and satisfaction will be measured via open-ended questions administered through a post-intervention interview
Measured: Immediately Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start29 Jun 2020
- Primary completion31 Mar 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of New Brunswick
- Responsible party
- Principal investigator, Patrick J. McGrath, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386330
- Sponsor's protocol ID
- 22081
- Status last verified
- Mar 2022
- First submitted
- 8 May 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37291963
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04386330
- Acronym / sponsor ID
- 22081
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of New Brunswick
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Narrative Exposure Therapy | Experimental | Behavioral: Distance-delivered NETFirefighters will receive distance-delivered NET administered by a paraprofessional. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distance-delivered NETOne-on-one intervention delivered by a paraprofessional; 12 weekly videoconference sessions at 90 minutes. | Behavioural | Narrative Exposure Therapy |
Primary outcome
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)
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)
Disability
Time frame: Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
Disability will be measured with the Sheehan Disability Scale
7 secondary outcomes
Anxiety Symptoms
Time frame: Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
Physical Health
Time frame: Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
Health Service Use
Time frame: Baseline, Immediately Post-intervention, 2 month follow up, 6 month follow up
Recruitment Rates
Time frame: Baseline
Intervention Adherence
Time frame: Immediately Post-Intervention
Coach Alliance
Time frame: Immediately Post-Intervention
Intervention Perceptions and Satisfaction
Time frame: Immediately Post-Intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 37291963Olthuis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distance-delivered NET in people with Post Traumatic Stress Disorder and Post Traumatic Stress Injury, run by IWK Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD/I symptoms (time frame: Baseline, Immediately Post- intervention, 2 month follow up, 6 month follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04386330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.