RESILIENT - An Online Multidimensional Treatment to Promote Resilience After a Disaster: Randomized Controlled Trial Protocol

NCT ID: NCT04808713

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-09
• Study Completion Date: 2019-05-31

Brief 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. 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.

Conditions

Post Traumatic Stress Disorder; Insomnia; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment condition

Group Type: EXPERIMENTAL

Treatment

Intervention Type: BEHAVIORAL

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.

Waitlist condition

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Treatment

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Geneviève Belleville

Full professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Laval University

Québec, , Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 31071909 (View on PubMed)

Belleville 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.

Reference Type: DERIVED

PMID: 36858756 (View on PubMed)

Other Identifiers

2017-030

Identifier Type: -

Identifier Source: org_study_id