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Online Treatment Platform for Traumatic Stress Disorders
N/A
Recruiting
Led By Genevieve Belleville, Ph.D.
Research Sponsored by Laval University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
Awards & highlights
No Placebo-Only Group
Summary
This trial seeks to explore if an online self-managed treatment platform can be effective for reducing psychological symptoms in sexual assault survivors, offering potential to fill a service gap for this population.
Who is the study for?
This trial is for women at least 18 years old who have experienced sexual assault after age 12, can read and speak French, and have internet access. They should show some post-traumatic stress symptoms, mild depression or subclinical insomnia but not be at high suicidal risk or currently receiving psychological treatment.
What is being tested?
The RESILIENT trial tests a self-managed online platform versus therapist-assisted online treatment to help victims of sexual assault cope with trauma, depression, and sleep issues. Participants will be randomly assigned to one of the two methods and evaluated over time.
What are the potential side effects?
Since this is a psychological intervention using cognitive behavioral therapy principles delivered online, there are no direct physical side effects like those seen with medication. However, participants may experience emotional discomfort while engaging with the content.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Depression Symptoms
Insomnia Symptoms
Post-traumatic Stress Disorder Symptoms
Secondary study objectives
Acceptability E-Scale
Anxiety Symptoms
Appreciation of the online intervention
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Self-Managed Online TreatmentExperimental Treatment1 Intervention
Participants manage their treatment online without the assistance of a therapist.
Group II: Therapist-Assisted Online TreatmentActive Control1 Intervention
Participant will be assisted through the process by a therapist who will provide support and encouragement for 15-20 minutes of contact per week for the duration of the treatment. Supportive contacts are not psychotherapy. They are intended to answer questions about the content of the platform, to review adherence to the exercises and to provide encouragement; they also allow for the rapid identification and referral of participants in case of need (e.g., suicidal crisis).
Find a Location
Who is running the clinical trial?
Laval UniversityLead Sponsor
434 Previous Clinical Trials
178,337 Total Patients Enrolled
Ministère de la Justice, QuébecUNKNOWN
Genevieve Belleville, Ph.D.Principal InvestigatorLaval University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am currently seeing improvements from my mental health treatment.I identify as a woman, at least partially.I can read and speak French.I have a history of bipolar or psychotic disorder.You have had a serious allergic reaction after the age of 12.
Research Study Groups:
This trial has the following groups:- Group 1: Self-Managed Online Treatment
- Group 2: Therapist-Assisted Online Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT05811897 — N/A