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NCT05811897Active, not recruiting

RESILIENT : A Self-Managed Online Platform for Victims of Sexual Assault

Un Meilleur Sommeil Pour Une Meilleure résilience : Une Plateforme en Ligne autogérée Pour Les Victimes d'Agression Sexuelle

Source: ClinicalTrials.gov · Last updated 28 Aug 2025

Brief summary (registry, in English)

There are 636,000 self-reported cases of sexual assault annually in Canada, and nine out of ten persons who have experienced sexual assault are women. Cognitive and behavioural therapies (CBT) are the treatment of choice for many psychological problems arising from sexual assault. However, accessing CBT is a significant challenge, especially for women who have experienced sexual assault who may be ashamed and not disclose the sexual assault. Online CBT is an effective option to circumvent these barriers. In addition to being accessible and less resource-intensive, studies report that patients are less inhibited and that the online environment provides greater emotional safety. There is also a growing body of evidence that online CBT programs requiring little or no contact with a mental health professional are effective, this having been demonstrated primarily with individuals with anxiety and mood disorders. But when it comes to treating the psychological symptoms of sexual assault in potentially vulnerable individuals, can we really suggest a self-care approach? There is no direct empirical evidence to support such a recommendation, and it is this important question that this project wishes to address. To compare the effectiveness, acceptability and user engagement in a self-managed treatment platform with or without the support of a therapist to reduce post-traumatic symptoms, depression and insomnia in people who have suffered one or more sexual assaults, 204 victims of sexual assault experiencing significant distress will be recruited and randomly assigned to either the self-managed or the therapist-assisted online treatment condition. Participants will complete measures assessing post-traumatic stress disorder, insomnia, depression, anxiety, and maladaptive beliefs before, during, after and 3 months after treatment. Secondary outcome will be and appreciation of the online treatment measures by a self-report questionnaire and a semi-structured interview. If effective in reducing symptoms, this treatment would offer the potential to support a self-care approach to treating a wide range of psychological symptoms resulting from sexual assault. The self-managed online platform would fill a service gap deplored by this population.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
204 (estimated)
First submitted
10 Feb 2023
Start date
1 Aug 2022
Primary completion date
31 Mar 2026
Lead sponsor
Laval University
Diseases
Depression
NCT number
NCT05811897

What you commit to

  • Study type: Interventional
  • Planned participants: 204
  • From 1 Aug 2022 to the primary completion date, 31 Mar 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Bipolar or psychotic disorder;
  • High suicidal risk, or any other condition requiring immediate intervention;

Other

  • Already benefiting from a psychological intervention.

Who the study is looking for

  • Identify at least in part as a woman;
  • Be at least 18 years old;
  • Have experienced SA after the age of 12;
  • Read and speak French;
  • Have adequate Internet access; and f) Present with some post-traumatic stress symptoms (PCL-5 ≥ 10) AND at least mild depressive symptoms (PHQ-9 ≥ 5) AND/OR subclinical insomnia symptoms (ISI ≥ 8).

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Laval University
Coordinator of this site? Confirm its status
QuébecCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.