Post Traumatic Stress DisorderRESILIENTNCT04808713
RESILIENT - An Online Multidimensional Treatment to Promote Resilience After a Disaster: Randomized Controlled Trial Protocol
A study testing Treatment in people with Post Traumatic Stress Disorder and Insomnia, run by Laval University at 1 site in Canada.
Trial summary
Background. The wildfires on May 1, 2016 in Fort McMurray, Alberta (Canada), destroyed approximately 2,400 homes and buildings and led to massive displacement of approximately 88,000 people. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder, Insomnia, Depression
- What is being tested?
- Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteCanada
- Study dates
- 9 May 2017to 31 May 2019
- 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 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Significant post-traumatic stress symptoms (PCL-5 ≥ 23) OR
- Some post-traumatic stress symptoms (PCL-5 ≥ 10) with at least mild depressive symptoms (PHQ-9 ≥ 5) and/or subclinical insomnia symptoms (ISI ≥ 8).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Background. The wildfires on May 1, 2016 in Fort McMurray, Alberta (Canada), destroyed approximately 2,400 homes and buildings and led to massive displacement of approximately 88,000 people. Many individuals faced direct or potential threat to their life or health, or significant losses, and many months later, families were still living through ongoing adversity and uncertainty as they adapted to new or temporary homes, schools and workplaces. Alberta Health Services estimated in August 2016 that mental health staff in the city had received 20,000 referrals since May, compared to 1,200 referrals each year.
Objectives. The overarching aim of this project is to understand the needs of the Fort McMurray population in terms of mental health and to widely disseminate evidence-based tools to promote resilience. More specifically, we will assess the efficacy of an online self-help intervention targeting post-traumatic resilience on specific symptoms (post-traumatic stress disorder [PTSD], insomnia, depression).
Read more
Method. 1,510 phone surveys have been conducted in May-July 2017 to assess the prevalence of PTSD, insomnia and depression in the evacuees from the Fort McMurray wildfires (T0). After the survey, 697 participants expressed interest to participate in the longitudinal arm of the study, which will include four in-depth assessments with online questionnaires (T1 to T4) and a diagnostic interview (T1 only). A period of six months will separate all four times of assessment. Participants with post-traumatic stress symptoms (expected n = 150) will be randomised either to the treatment condition (n = 75) or to a waitlist control condition (n = 75) after completion of T2.
Data Analyses. Primary outcomes will be post-traumatic, depressive and insomnia symptom severity, measured with validated self-report questionnaires. Secondary outcomes will include cognitive, behavioural and social indicators, as well as general mental health and post-traumatic growth. Several probable moderators of treatment will be examined, including sociodemographic characteristics, level of exposure, and continuing stressors.
Foreseen Impacts. If found effective in reducing symptoms, the results of this study have the potential to impact positively the Fort McMurray community. Indeed, a direct and concrete deliverable of this research project will be to provide an extended (at least two years) and free access to the online intervention specifically tailored to this population's needs.
- Conditions
- Post Traumatic Stress Disorder, Insomnia, Depression
- Being tested
- Treatment
- Keywords
- mental health, post-traumatic stress disorder, psychological distress, sleep
- Medical subject headings
- Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentBehavioural
The treatment is a therapist-assisted self-help online cognitive-behaviour therapy focusing on post-traumatic stress, sleep and mood. It includes 12 sessions of evidence-based psychotherapeutic components, such as psychoeducation about PTSD, sleep and depression; prolonged exposure to avoided situations and memories; sleep management strategies (restriction of time in bed, stimulus control, sleep hygiene education); behavioural activation; relaxation and mindfulness exercises; problem-solving strategies; and cognitive restructuring. A small portion of material was unlocked each week, and access to one module was accessible after the completion of a previous one. Supervised graduate psychology students provided brief regular weekly contacts for 12 weeks by video chat or phone, according to the participant's preference. Access to the online material was unlimited in time.
| Study group | Role | What they receive |
|---|---|---|
| Treatment condition | Experimental | Not described Receives: Behavioral: Treatment |
| Waitlist condition | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Traumatic Stress Disorder
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5) - This self-reported questionnaire includes 20 items on a 5-point Likert scale (from 0 = Not at all to 4 = Extremely) evaluating posttraumatic symptoms in the past month. The total score range between 0 and 80 with higher scores indicating higher symptoms severity.
Measured: 6 months
Depression
Patient Health Questionnaire Depression Scale (PHQ-9) - This self-reported questionnaire includes nine items on a 4-point Likert scale (from 0 = Not at all to 3 = Nearly every day). Total severity scores range from 0 to 27, with a higher score indicating a higher severity.
Measured: 6 months
Insomnia (ISI)
Insomnia Severity Index (ISI) - This self-reported questionnaire includes seven items rated on a 5-point Likert scale (from 0 = No problem to 4 = Very severe problem) that evaluate sleep difficulties in the past two weeks. Total severity scores range from 0 to 28, with a higher score indicating a higher severity of insomnia.
Measured: 6 months
Secondary outcomes (2)
Daily Functioning
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) - This self-reported questionnaire includes 36 items on a 5-point Likert scale (from 0 = No difficulty to 4 = Extreme difficulty or cannot do) evaluating functioning in the past month and covering 6 domains: Understanding and Communicating (6 items), Getting around (5 items), Self-care (4 items), Getting along with others (5 items), Life activities (8 items), and Participation in society (8 items).
Measured: 6 months
Generalized Anxiety Disorder
Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7) - This self-reported questionnaire includes 7 items on a 4-point Likert scale (from 0 = Not at all to 3 = Nearly every day) evaluating anxiety symptoms in the past two weeks. The total score range between 0 and 21 with higher scores indicating higher symptoms severity.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start9 May 2017
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Geneviève Belleville, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808713
- Sponsor's protocol ID
- 2017-030
- Acronym
- RESILIENT
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Belleville G, Ouellet MC, Morin CM. Post-Traumatic Stress among Evacuees from the 2016 Fort McMurray Wildfires: Exploration of Psychological and Sleep Symptoms Three Months after the Evacuation. Int J Environ Res Public Health. 2019 May 8;16(9):1604. doi: 10.3390/ijerph16091604.
PubMed 31071909Belleville G, Ouellet MC, Bekes V, Lebel J, Morin CM, Bouchard S, Guay S, Bergeron N, Ghosh S, Campbell T, Macmaster FP. Efficacy of a Therapist-Assisted Self-Help Internet-Based Intervention Targeting PTSD, Depression, and Insomnia Symptoms After a Disaster: A Randomized Controlled Trial. Behav Ther. 2023 Mar;54(2):230-246. doi: 10.1016/j.beth.2022.08.004. Epub 2022 Aug 19.
PubMed 36858756
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESILIENT - An Online Multidimensional Treatment to Promote Resilience After a Disaster: Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT04808713
- Acronym / sponsor ID
- RESILIENT / 2017-030
- Conditions
- Post Traumatic Stress Disorder, Insomnia, Depression
- Keywords
- mental health, post-traumatic stress disorder, psychological distress, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 9 May 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 22 Mar 2021 (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.
Background. The wildfires on May 1, 2016 in Fort McMurray, Alberta (Canada), destroyed approximately 2,400 homes and buildings and led to massive displacement of approximately 88,000 people. Many individuals faced direct or potential threat to their life or health, or significant losses, and many months later, families were still living through ongoing adversity and uncertainty as they adapted to new or temporary homes, schools and workplaces. Alberta Health Services estimated in August 2016 that mental health staff in the city had received 20,000 referrals since May, compared to 1,200 referrals each year.
Objectives. The overarching aim of this project is to understand the needs of the Fort McMurray population in terms of mental health and to widely disseminate evidence-based tools to promote resilience. More specifically, we will assess the efficacy of an online self-help intervention targeting post-traumatic resilience on specific symptoms (post-traumatic stress disorder [PTSD], insomnia, depression).
Method. 1,510 phone surveys have been conducted in May-July 2017 to assess the prevalence of PTSD, insomnia and depression in the evacuees from the Fort McMurray wildfires (T0). After the survey, 697 participants expressed interest to participate in the longitudinal arm of the study, which will include four in-depth assessments with online questionnaires (T1 to T4) and a diagnostic interview (T1 only). A period of six months will separate all four times of assessment. Participants with post-traumatic stress symptoms (expected n = 150) will be randomised either to the treatment condition (n = 75) or to a waitlist control condition (n = 75) after completion of T2.
Data Analyses. Primary outcomes will be post-traumatic, depressive and insomnia symptom severity, measured with validated self-report questionnaires. Secondary outcomes will include cognitive, behavioural and social indicators, as well as general mental health and post-traumatic growth. Several probable moderators of treatment will be examined, including sociodemographic characteristics, level of exposure, and continuing stressors.
Foreseen Impacts. If found effective in reducing symptoms, the results of this study have the potential to impact positively the Fort McMurray community. Indeed, a direct and concrete deliverable of this research project will be to provide an extended (at least two years) and free access to the online intervention specifically tailored to this population's needs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment condition | Experimental | Behavioral: Treatment |
| Waitlist condition | No intervention | – |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Significant post-traumatic stress symptoms (PCL-5 ≥ 23) OR
- Some post-traumatic stress symptoms (PCL-5 ≥ 10) with at least mild depressive symptoms (PHQ-9 ≥ 5) and/or subclinical insomnia symptoms (ISI ≥ 8).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TreatmentThe treatment is a therapist-assisted self-help online cognitive-behaviour therapy focusing on post-traumatic stress, sleep and mood. It includes 12 sessions of evidence-based psychotherapeutic components, such as psychoeducation about PTSD, sleep and depression; prolonged exposure to avoided situations and memories; sleep management strategies (restriction of time in bed, stimulus control, sleep hygiene education); behavioural activation; relaxation and mindfulness exercises; problem-solving strategies; and cognitive restructuring. A small portion of material was unlocked each week, and access to one module was accessible after the completion of a previous one. Supervised graduate psychology students provided brief regular weekly contacts for 12 weeks by video chat or phone, according to the participant's preference. Access to the online material was unlimited in time. | Behavioural | Treatment condition |
Primary outcome
Post-Traumatic Stress Disorder
Time frame: 6 months
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5) - This self-reported questionnaire includes 20 items on a 5-point Likert scale (from 0 = Not at all to 4 = Extremely) evaluating posttraumatic symptoms in the past month. The total score range between 0 and 80 with higher scores indicating higher symptoms severity.
Depression
Time frame: 6 months
Patient Health Questionnaire Depression Scale (PHQ-9) - This self-reported questionnaire includes nine items on a 4-point Likert scale (from 0 = Not at all to 3 = Nearly every day). Total severity scores range from 0 to 27, with a higher score indicating a higher severity.
Insomnia (ISI)
Time frame: 6 months
Insomnia Severity Index (ISI) - This self-reported questionnaire includes seven items rated on a 5-point Likert scale (from 0 = No problem to 4 = Very severe problem) that evaluate sleep difficulties in the past two weeks. Total severity scores range from 0 to 28, with a higher score indicating a higher severity of insomnia.
2 secondary outcomes
Daily Functioning
Time frame: 6 months
Generalized Anxiety Disorder
Time frame: 6 months
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 13 Mar 2024.
- Background: PubMed 31071909Belleville G, Ouellet MC, Morin CM. Post-Traumatic Stress among Evacuees from the 2016 Fort McMurray Wildfires: Exploration of Psychological and Sleep Symptoms Three Months after the Evacuation. Int J Environ Res Public Health. 2019 May 8;16(9):1604. doi: 10.3390/ijerph16091604.
- Derived from this study: PubMed 36858756Belleville G, Ouellet MC, Bekes V, Lebel J, Morin CM, Bouchard S, Guay S, Bergeron N, Ghosh S, Campbell T, Macmaster FP. Efficacy of a Therapist-Assisted Self-Help Internet-Based Intervention Targeting PTSD, Depression, and Insomnia Symptoms After a Disaster: A Randomized Controlled Trial. Behav Ther. 2023 Mar;54(2):230-246. doi: 10.1016/j.beth.2022.08.004. Epub 2022 Aug 19.
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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 Treatment in people with Post Traumatic Stress Disorder and Insomnia, run by Laval University 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 2 inclusion and 0 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 13 Mar 2024. 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?
Post-Traumatic Stress Disorder (time frame: 6 months). 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 NCT04808713, which also lists 2 linked publications.
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 13 Mar 2024.