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

NCT05811897 | Active Not Recruiting

• 1 other identifier: 2021-409
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Traumatic Stress Disorder; Insomnia Disorder; Major Depressive Disorder

Keywords

mental health; post-traumatic stress disorder; psychological distress; sleep

Outcome Measures

Primary Outcomes (9)

• Post-traumatic Stress Disorder Symptoms

  PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5) - This self-reported questionnaire includes 20 items on a 5-point Likert scale (from 0 = Not at all to 4 = Extremely) evaluating posttraumatic symptoms in the past month. The total score range between 0 and 80 with higher scores indicating higher symptoms severity.

  Pre-treatment

• Post-traumatic Stress Disorder Symptoms

  PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5) - This self-reported questionnaire includes 20 items on a 5-point Likert scale (from 0 = Not at all to 4 = Extremely) evaluating posttraumatic symptoms in the past month. The total score range between 0 and 80 with higher scores indicating higher symptoms severity.

  Post module (an average of 10 weeks)

• Post-traumatic Stress Disorder Symptoms

  PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5) - This self-reported questionnaire includes 20 items on a 5-point Likert scale (from 0 = Not at all to 4 = Extremely) evaluating posttraumatic symptoms in the past month. The total score range between 0 and 80 with higher scores indicating higher symptoms severity.

  3 months follow-up (12 weeks after last module, which takes on average 30 weeks)

• Depression Symptoms

  Patient Health Questionnaire Depression Scale (PHQ-9) - This self-reported questionnaire includes nine items on a 4-point Likert scale (from 0 = Not at all to 3 = Nearly every day). Total severity scores range from 0 to 27, with a higher score indicating a higher severity.

  Pre-treatment

• Depression Symptoms

  Patient Health Questionnaire Depression Scale (PHQ-9) - This self-reported questionnaire includes nine items on a 4-point Likert scale (from 0 = Not at all to 3 = Nearly every day). Total severity scores range from 0 to 27, with a higher score indicating a higher severity.

  Post module (an average of 10 weeks)

• Depression Symptoms

  Patient Health Questionnaire Depression Scale (PHQ-9) - This self-reported questionnaire includes nine items on a 4-point Likert scale (from 0 = Not at all to 3 = Nearly every day). Total severity scores range from 0 to 27, with a higher score indicating a higher severity.

  3 months follow-up (12 weeks after last module, which takes on average 30 weeks)

• Insomnia Symptoms

  Insomnia Severity Index (ISI) - This self-reported questionnaire includes seven items rated on a 5-point Likert scale (from 0 = No problem to 4 = Very severe problem) that evaluate sleep difficulties in the past two weeks. Total severity scores range from 0 to 28, with a higher score indicating a higher severity of insomnia.

  Pre-treatment

• Insomnia Symptoms

  Insomnia Severity Index (ISI) - This self-reported questionnaire includes seven items rated on a 5-point Likert scale (from 0 = No problem to 4 = Very severe problem) that evaluate sleep difficulties in the past two weeks. Total severity scores range from 0 to 28, with a higher score indicating a higher severity of insomnia.

  Post module (an average of 10 weeks)

• Insomnia Symptoms

  Insomnia Severity Index (ISI) - This self-reported questionnaire includes seven items rated on a 5-point Likert scale (from 0 = No problem to 4 = Very severe problem) that evaluate sleep difficulties in the past two weeks. Total severity scores range from 0 to 28, with a higher score indicating a higher severity of insomnia.

  3 months follow-up (12 weeks after last module, which takes on average 30 weeks)

Secondary Outcomes (16)

• Sleep quality

  Pre-treatment

• Sleep quality

  Post module (an average of 10 weeks)

• Sleep quality

  3 months follow-up (12 weeks after last module, which takes on average 30 weeks)

• Nightmares

  Pre-treatment

• Nightmares

  Post module (an average of 10 weeks)

Study Arms (2)

Self-Managed Online Treatment

EXPERIMENTAL

Participants manage their treatment online without the assistance of a therapist.

Behavioral: Self-Managed Online Treatment

Therapist-Assisted Online Treatment

ACTIVE COMPARATOR

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).

Behavioral: Therapist-Assisted Online Treatment

Interventions

Self-Managed Online Treatment BEHAVIORAL

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.

Self-Managed Online Treatment

Therapist-Assisted Online Treatment BEHAVIORAL

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.

Therapist-Assisted Online Treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All persons identifying at least in part with the female gender are included
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Bipolar or psychotic disorder;
• High suicidal risk, or any other condition requiring immediate intervention;
• Already benefiting from a psychological intervention.

Sponsors & Collaborators

• Laval University: lead
• Ministère de la Justice, Québec: collaborator

Study Sites (1)

Laval University

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (4)

• Linde K, Sigterman K, Kriston L, Rucker G, Jamil S, Meissner K, Schneider A. Effectiveness of psychological treatments for depressive disorders in primary care: systematic review and meta-analysis. Ann Fam Med. 2015 Jan-Feb;13(1):56-68. doi: 10.1370/afm.1719.

  PMID: 25583894 BACKGROUND

• Bambling, M., et al. (2008).

  BACKGROUND

• Cook JE, Doyle C. Working alliance in online therapy as compared to face-to-face therapy: preliminary results. Cyberpsychol Behav. 2002 Apr;5(2):95-105. doi: 10.1089/109493102753770480.

  PMID: 12025884 BACKGROUND

• Jagger F. The export boning and cutting plant. Vet Rec. 1972 Dec 16;91(25):626-9. doi: 10.1136/vr.91.25.626. No abstract available.

  PMID: 4651423 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Sleep Initiation and Maintenance Disorders; Depressive Disorder, Major; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Depressive Disorder; Mood Disorders; Personal Satisfaction; Behavior

Study Officials

• Genevieve Belleville, Ph.D.

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: April 13, 2023
• Study Start: August 1, 2022
• Primary Completion: March 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)