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Clinical Trials in Canada / NCT05811897
Active, not recruiting Not applicable

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

NCT05811897 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2022-08-01
Last updated
2025-08-28

Condition(s) studied

Post Traumatic Stress DisorderInsomnia DisorderMajor Depressive Disorder

Investigational drug(s) / intervention(s)

Self-Managed Online TreatmentTherapist-Assisted Online Treatment

Self-Managed Online Treatment: Self-help online cognitive-behavioural therapy focusing on post-traumatic stress, sleep and mood. The content is divided into three modules : * Coping with my trauma: psychoeducation about PTSD, cognitive restructuring prolonged exposure to avoided situations and memories (14 sessions) * Sleeping better: psychoeducation about, sleep management strategies (restriction of time in bed, stimulus control, sleep hygiene education), Imagery Rehearsal Therapy (10 sessions) * Improving my mood: psychoeducation about depression, behavioural activation; relaxation and mindfulness exercises; problem-solving strategies (6 sessions) A small portion of material is unlocked each week, and access to one module will be accessible after the completion of a previous one. Access to the online material will be unlimited in time. Participants complete self-report questionnaires after each module, the platform then provides feedback and suggests corresponding modules.

Therapist-Assisted Online Treatment: Same online intervention. Supervised graduate psychology students will provide brief regular weekly contacts for up to 30 weeks by video chat or phone, according to the participant's preference.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. Identify at least in part as a woman; 2. Be at least 18 years old; 3. Have experienced SA after the age of 12; 4. Read and speak French; 5. 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). Exclusion Criteria : 1. Bipolar or psychotic disorder; 2. High suicidal risk, or any other condition requiring immediate intervention; 3. Already benefiting from a psychological intervention.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Laval University Québec Quebec

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05811897 on ClinicalTrials.gov ↗ ← All trials in Canada