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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 at least 18 years old
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

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Depression Symptoms
Insomnia Symptoms
Post-traumatic Stress Disorder Symptoms
Secondary outcome measures
Acceptability E-Scale
Anxiety Symptoms
Appreciation of the online intervention
+5 more

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
416 Previous Clinical Trials
172,072 Total Patients Enrolled
Ministère de la Justice, QuébecUNKNOWN
Genevieve Belleville, Ph.D.Principal InvestigatorLaval University

Media Library

Self-Managed Online Treatment Clinical Trial Eligibility Overview. Trial Name: NCT05811897 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Self-Managed Online Treatment, Therapist-Assisted Online Treatment
Post-Traumatic Stress Disorder Clinical Trial 2023: Self-Managed Online Treatment Highlights & Side Effects. Trial Name: NCT05811897 — N/A
Self-Managed Online Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05811897 — N/A
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT05811897 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals still being sought for participation in this experiment?

"Correct. Clinicaltrials.gov attests that this medical trial, posted on August 1st 2022 and last modified March 31 2023, is currently accepting participants. A total of 204 patients can be recruited from a single centre."

Answered by AI

How many participants are currently enrolled in this research study?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial began on August 1st 2022 and was last revised March 31st 2023 with the aim of recruiting 204 participants from one site."

Answered by AI

What are the objectives of this investigation?

"This clinical trial aims to assess its efficacy in treating depression over a 3 month period, with secondary measures encompassing nightmares severity (as recorded by the NDQ), anxiety symptoms as measured via GAD-7 and participants' perceptions of their violence experience through the Rape Attribution Questionnaire."

Answered by AI

Who else is applying?

What state do they live in?
Quebec
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

What questions have other patients asked about this trial?

Hiw long is each visit?
PatientReceived no prior treatments

Why did patients apply to this trial?

I have tried various treatments to no avail. I am stuck and am looking for anyway to move forward. I am a year out from my surgical trauma and still experiencing significant issues and SI. In addition to PTSD, I was diagnosed with mixed obsessional thoughts and acts.
PatientReceived 1 prior treatment
~0 spots leftby Mar 2024