Clinical trial NCT05811897: RESILIENT : a Self-Managed Online Platform for Victims of Sexual Assault
Official title: Un Meilleur Sommeil Pour Une Meilleure Résilience : Une Plateforme En Ligne Autogérée Pour Les Victimes D'agression Sexuelle
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Insomnia Disorder
Major Depressive Disorder
Keywords: mental health
post-traumatic stress disorder
psychological distress
sleep
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Ministère de la Justice, Québec
First posted: 2023-04-13
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Background. 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. An alarming paradox is that although they suffer significant adverse consequences of sexual assault on their functioning, they have less social support than victims of other traumatic events to manage the psychological consequences of sexual assault. 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.

Objectives. To compare the effectiveness of the use of 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, to document the acceptability of the platform and user engagement in the platform.

Method. For this study, 204 victims of sexual assault experiencing significant distress will be recruited. Of these participants, 102 will be randomly assigned to the self-managed online treatment condition and 102 participants will be randomly assigned to the therapist-assisted online treatment condition. Both conditions will have access to the same online platform (RESILIENT) that contains modules addressing the reduction of post-traumatic stress, insomnia, and depression symptoms, as well as nightmares. The duration of the online treatment is flexible and can last up to 25 weeks.

Data analyses. Primary outcome are post-traumatic stress disorder, insomnia, depression and anxiety measured by self-report questionnaires assessing participants' symptoms completed before, during and 3 months after treatment. Secondary outcome will be maladaptive beliefs and appreciation of the online treatment measures by a self-report questionnaire and a semi-structured interview.

Foreseen impacts. 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 criteria: 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 outcomes:
measure: Post-traumatic Stress Disorder Symptoms
timeFrame: Pre-treatment
measure: Post-traumatic Stress Disorder Symptoms
timeFrame: Post module (an average of 10 weeks)
measure: Post-traumatic Stress Disorder Symptoms
timeFrame: 3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
measure: Depression Symptoms
timeFrame: Pre-treatment
measure: Depression Symptoms
timeFrame: Post module (an average of 10 weeks)
measure: Depression Symptoms
timeFrame: 3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
measure: Insomnia Symptoms
timeFrame: Pre-treatment
measure: Insomnia Symptoms
timeFrame: Post module (an average of 10 weeks)
measure: Insomnia Symptoms
timeFrame: 3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
Secondary outcomes:
measure: Sleep quality
timeFrame: Pre-treatment
measure: Sleep quality
timeFrame: Post module (an average of 10 weeks)
measure: Sleep quality
timeFrame: 3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
measure: Nightmares
timeFrame: Pre-treatment
measure: Nightmares
timeFrame: Post module (an average of 10 weeks)
measure: Nightmares
timeFrame: 3 month follow-up (12 weeks after last module, which takes on average 30 weeks)
measure: Anxiety Symptoms
timeFrame: Pre treatment
measure: Anxiety Symptoms
timeFrame: Post module (an average of 10 weeks)
measure: Anxiety Symptoms
timeFrame: 3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
measure: Rape Attribution
timeFrame: Pre-treatment
measure: Rape Attribution
timeFrame: Post- CT module (an average of 5 weeks)
measure: Maladaptive Beliefs
timeFrame: Pre-treatment
measure: Maladaptive Beliefs
timeFrame: Post- CT module (an average of 5 weeks)
measure: Acceptability E-Scale
timeFrame: Post last module (an average of 30 weeks)
measure: Appreciation of the online intervention
timeFrame: Post last module (an average of 30 weeks)
measure: Semi-structured qualitative interview
timeFrame: Post last module (an average of 30 weeks)
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Laval University
state: Quebec
Study officials:
affiliation: Laval University
name: Genevieve Belleville, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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