- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05811897
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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Genevieve Belleville, Ph.D.
- Phone Number: 404226 1-418-656-2131
- Email: genevieve.belleville@psy.ulaval.ca
Study Contact Backup
- Name: Jessica Lebel, M.A.
- Phone Number: 405068 1-418-656-2131
- Email: jessica.lebel@psy.ulaval.ca
Study Locations
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Québec, Canada, G1V 0A6
- Recruiting
- Laval University
-
Contact:
- Genevieve Belleville, Ph.D
- Phone Number: 404226 1-418-656-2131
- Email: genevieve.belleville@psy.ulaval.ca
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria :
- Bipolar or psychotic disorder;
- High suicidal risk, or any other condition requiring immediate intervention;
- Already benefiting from a psychological intervention.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Self-Managed Online Treatment
Participants manage their treatment online without the assistance of a therapist.
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Self-help online cognitive-behavioural therapy focusing on post-traumatic stress, sleep and mood. The content is divided into three modules :
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. |
Active Comparator: Therapist-Assisted Online Treatment
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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-traumatic Stress Disorder Symptoms
Time Frame: Pre-treatment
|
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
Time Frame: Post module (an average of 10 weeks)
|
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.
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Post module (an average of 10 weeks)
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Post-traumatic Stress Disorder Symptoms
Time Frame: 3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
|
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
Time Frame: Pre-treatment
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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.
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Pre-treatment
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Depression Symptoms
Time Frame: Post module (an average of 10 weeks)
|
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.
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Post module (an average of 10 weeks)
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Depression Symptoms
Time Frame: 3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
|
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.
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3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
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Insomnia Symptoms
Time Frame: Pre-treatment
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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.
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Pre-treatment
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Insomnia Symptoms
Time Frame: Post module (an average of 10 weeks)
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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.
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Post module (an average of 10 weeks)
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Insomnia Symptoms
Time Frame: 3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
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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.
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3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep quality
Time Frame: Pre-treatment
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Pittsburgh Sleep Quality Index (IQSP)-This self-reported questionnaire evaluating the sleep patterns over the past month.
Responses should be the best possible estimates for the majority of days and nights in the last month.
Nineteen individual items generate seven component scores, each weighted equally on a 0-3 scale.
The sum of the 7 component score yields a total global score, which has a range of 0-21; higher scores indicate worse sleep quality.
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Pre-treatment
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Sleep quality
Time Frame: Post module (an average of 10 weeks)
|
Pittsburgh Sleep Quality Index (IQSP)-This self-reported questionnaire evaluating the sleep patterns over the past month.
Responses should be the best possible estimates for the majority of days and nights in the last month.
Nineteen individual items generate seven component scores, each weighted equally on a 0-3 scale.
The sum of the 7 component score yields a total global score, which has a range of 0-21; higher scores indicate worse sleep quality.
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Post module (an average of 10 weeks)
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Sleep quality
Time Frame: 3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
|
Pittsburgh Sleep Quality Index (IQSP)-This self-reported questionnaire evaluating the sleep patterns over the past month.
Responses should be the best possible estimates for the majority of days and nights in the last month.
Nineteen individual items generate seven component scores, each weighted equally on a 0-3 scale.
The sum of the 7 component score yields a total global score, which has a range of 0-21; higher scores indicate worse sleep quality.
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3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
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Nightmares
Time Frame: Pre-treatment
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Nightmares Distress Questionnaire (NDQ)- This self-reported questionnaire includes 13 items on a 7-points Likert scale (1= Always to 4= Never) evaluating distress associated with nightmares.
A higher score indicates a more severe distress due to nightmares.
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Pre-treatment
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Nightmares
Time Frame: Post module (an average of 10 weeks)
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Nightmares Distress Questionnaire (NDQ)- This self-reported questionnaire includes 13 items on a 7-points Likert scale (1= Always to 4= Never) evaluating distress associated with nightmares.
A higher score indicates a more severe distress due to nightmares.
|
Post module (an average of 10 weeks)
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Nightmares
Time Frame: 3 month follow-up (12 weeks after last module, which takes on average 30 weeks)
|
Nightmares Distress Questionnaire (NDQ)- This self-reported questionnaire includes 13 items on a 7-points Likert scale (1= Always to 4= Never) evaluating distress associated with nightmares.
A higher score indicates a more severe distress due to nightmares.
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3 month follow-up (12 weeks after last module, which takes on average 30 weeks)
|
Anxiety Symptoms
Time Frame: Pre treatment
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Generalized Anxiety Disorder Scale (GAD-7) - This self-reported questionnaire includes 7 items on a 4-point Likert scale (from 0 = Not at all to 3 = Nearly every day) evaluating anxiety symptoms in the past two weeks.
The total score range between 0 and 21 with higher scores indicating higher symptoms severity.
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Pre treatment
|
Anxiety Symptoms
Time Frame: Post module (an average of 10 weeks)
|
Generalized Anxiety Disorder Scale (GAD-7) - This self-reported questionnaire includes 7 items on a 4-point Likert scale (from 0 = Not at all to 3 = Nearly every day) evaluating anxiety symptoms in the past two weeks.
The total score range between 0 and 21 with higher scores indicating higher symptoms severity.
|
Post module (an average of 10 weeks)
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Anxiety Symptoms
Time Frame: 3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
|
Generalized Anxiety Disorder Scale (GAD-7) - This self-reported questionnaire includes 7 items on a 4-point Likert scale (from 0 = Not at all to 3 = Nearly every day) evaluating anxiety symptoms in the past two weeks.
The total score range between 0 and 21 with higher scores indicating higher symptoms severity.
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3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
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Rape Attribution
Time Frame: Pre-treatment
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Rape Attribution Questionnaire (French version)-This questionnaire includes a 25 items on a 5-points Likert scale (1= Never to 5= Very often) evaluating participants' beliefs in the past month about the aggression they experienced.
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Pre-treatment
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Rape Attribution
Time Frame: Post- CT module (an average of 5 weeks)
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Rape Attribution Questionnaire (French version)-This questionnaire includes a 25 items on a 5-points Likert scale (1= Never to 5= Very often) evaluating participants' beliefs in the past month about the aggression they experienced.
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Post- CT module (an average of 5 weeks)
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Maladaptive Beliefs
Time Frame: Pre-treatment
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Posttraumatic Maladaptive Beliefs Scale (French version - under validation)-This self-reported questionnaire includes 14 items on a 7-points Likert scale (1= Completely false to 7= Completely true) evaluating post traumatic maladaptive beliefs of participants.
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Pre-treatment
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Maladaptive Beliefs
Time Frame: Post- CT module (an average of 5 weeks)
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Posttraumatic Maladaptive Beliefs Scale (French version - under validation)-This self-reported questionnaire includes 14 items on a 7-points Likert scale (1= Completely false to 7= Completely true) evaluating post traumatic maladaptive beliefs of participants.
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Post- CT module (an average of 5 weeks)
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Acceptability E-Scale
Time Frame: Post last module (an average of 30 weeks)
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This self-reported questionnaire includes 6 items on a 4-point Likert scale (1= Not at all to 4= a lot) evaluating participant satisfaction with the online intervention.
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Post last module (an average of 30 weeks)
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Appreciation of the online intervention
Time Frame: Post last module (an average of 30 weeks)
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Atrakdiff 2 (RESILIENT platform)-This self-reported questionnaire is a 21 items on a semantic differentiator scale where participants choose words that are closer to their perception of the online intervention among a list of contrasting adjectives.
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Post last module (an average of 30 weeks)
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Semi-structured qualitative interview
Time Frame: Post last module (an average of 30 weeks)
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This semi-structured interview evaluate participants' appreciation of the online platform.
The interviewer must ensure that the interview does not exceed 30 minutes and that the content of the interview is limited to the proposed themes.
However, the interviewer may modify the questions, add sub-questions and change the order of the questions in order to meet the objectives of the study and to adapt to each participant's speech.
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Post last module (an average of 30 weeks)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Genevieve Belleville, Ph.D., Laval University
Publications and helpful links
General Publications
- Ye YY, Zhang YF, Chen J, Liu J, Li XJ, Liu YZ, Lang Y, Lin L, Yang XJ, Jiang XJ. Internet-Based Cognitive Behavioral Therapy for Insomnia (ICBT-i) Improves Comorbid Anxiety and Depression-A Meta-Analysis of Randomized Controlled Trials. PLoS One. 2015 Nov 18;10(11):e0142258. doi: 10.1371/journal.pone.0142258. eCollection 2015.
- 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.
- 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.
- Bambling, M., et al. (2008).
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Mood Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Trauma and Stressor Related Disorders
- Depressive Disorder
- Sleep Initiation and Maintenance Disorders
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- Depressive Disorder, Major
Other Study ID Numbers
- 2021-409
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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