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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 month 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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months follow-up (12 weeks after last module, which takes on average 30 weeks) for reporting.

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 more

Awards & 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).

Do I qualify?Apply below to find out