Post Traumatic Stress DisorderNCT05811897
RESILIENT : A Self-Managed Online Platform for Victims of Sexual Assault
A study testing Self-Managed Online Treatment and Therapist-Assisted Online Treatment in people with Post Traumatic Stress Disorder and Insomnia Disorder, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder, Insomnia Disorder, Major Depressive Disorder
- What is being tested?
- Self-Managed Online Treatment and Therapist-Assisted Online Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2022to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Bipolar or psychotic disorder;
- High suicidal risk, or any other condition requiring immediate intervention;
- Already benefiting from a psychological intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Un Meilleur Sommeil Pour Une Meilleure résilience : Une Plateforme en Ligne autogérée Pour Les Victimes d'Agression Sexuelle
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.
Read the 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.
- Being tested
- Self-Managed Online Treatment, Therapist-Assisted Online Treatment
- Keywords
- mental health, post-traumatic stress disorder, psychological distress, sleep
- Medical subject headings
- Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders, Depressive Disorder, Major, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Managed Online TreatmentBehavioural
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 TreatmentBehavioural
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 group | Role | What they receive |
|---|---|---|
| Self-Managed Online Treatment | Experimental | Participants manage their treatment online without the assistance of a therapist. Receives: 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). Receives: Behavioral: Therapist-Assisted Online Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
Secondary outcomes (16)
Sleep quality
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.
Measured: Pre-treatment
Sleep quality
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.
Measured: Post module (an average of 10 weeks)
Sleep quality
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.
Measured: 3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
Nightmares
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.
Measured: Pre-treatment
Nightmares
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.
Measured: Post module (an average of 10 weeks)
Nightmares
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.
Measured: 3 month follow-up (12 weeks after last module, which takes on average 30 weeks)
Anxiety Symptoms
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.
Measured: Pre treatment
Anxiety Symptoms
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.
Measured: Post module (an average of 10 weeks)
Anxiety Symptoms
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.
Measured: 3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
Rape Attribution
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.
Measured: Pre-treatment
Rape Attribution
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.
Measured: Post- CT module (an average of 5 weeks)
Maladaptive Beliefs
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.
Measured: Pre-treatment
Maladaptive Beliefs
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.
Measured: Post- CT module (an average of 5 weeks)
Acceptability E-Scale
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.
Measured: Post last module (an average of 30 weeks)
Appreciation of the online intervention
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.
Measured: Post last module (an average of 30 weeks)
Semi-structured qualitative interview
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.
Measured: Post last module (an average of 30 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 Aug 2022
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministère de la Justice, Québec
- Responsible party
- Principal investigator, Geneviève Belleville, Laval University
- Investigators
- Genevieve Belleville, Ph.D., Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811897
- Sponsor's protocol ID
- 2021-409
- Status last verified
- Aug 2025
- First submitted
- 10 Feb 2023
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25583894Bambling, M., et al. (2008).
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.
PubMed 12025884Ye 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.
PubMed 26581107
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Un Meilleur Sommeil Pour Une Meilleure résilience : Une Plateforme en Ligne autogérée Pour Les Victimes d'Agression Sexuelle
- ClinicalTrials.gov ID
- NCT05811897
- Acronym / sponsor ID
- 2021-409
- Keywords
- mental health, post-traumatic stress disorder, psychological distress, sleep
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Ministère de la Justice, Québec
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Managed Online Treatment | Experimental | Behavioral: Self-Managed Online TreatmentParticipants manage their treatment online without the assistance of a therapist. |
| Therapist-Assisted Online Treatment | Active comparator | Behavioral: Therapist-Assisted Online TreatmentParticipant 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- Bipolar or psychotic disorder;
- High suicidal risk, or any other condition requiring immediate intervention;
- Already benefiting from a psychological intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Managed Online TreatmentSelf-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. | Behavioural | Self-Managed Online Treatment |
| Therapist-Assisted Online TreatmentSame 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. | Behavioural | Therapist-Assisted Online Treatment |
Primary outcome
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.
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.
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.
Depression Symptoms
Time frame: Pre-treatment
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.
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.
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.
Insomnia Symptoms
Time frame: Pre-treatment
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.
Insomnia Symptoms
Time frame: Post module (an average of 10 weeks)
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.
Insomnia Symptoms
Time frame: 3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
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.
16 secondary outcomes
Sleep quality
Time frame: Pre-treatment
Sleep quality
Time frame: Post module (an average of 10 weeks)
Sleep quality
Time frame: 3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
Nightmares
Time frame: Pre-treatment
Nightmares
Time frame: Post module (an average of 10 weeks)
Nightmares
Time frame: 3 month follow-up (12 weeks after last module, which takes on average 30 weeks)
Anxiety Symptoms
Time frame: Pre treatment
Anxiety Symptoms
Time frame: Post module (an average of 10 weeks)
Anxiety Symptoms
Time frame: 3 months follow-up (12 weeks after last module, which takes on average 30 weeks)
Rape Attribution
Time frame: Pre-treatment
Rape Attribution
Time frame: Post- CT module (an average of 5 weeks)
Maladaptive Beliefs
Time frame: Pre-treatment
Maladaptive Beliefs
Time frame: Post- CT module (an average of 5 weeks)
Acceptability E-Scale
Time frame: Post last module (an average of 30 weeks)
Appreciation of the online intervention
Time frame: Post last module (an average of 30 weeks)
Semi-structured qualitative interview
Time frame: Post last module (an average of 30 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Background: PubMed 25583894Linde 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.
- BackgroundBambling, M., et al. (2008).
- Background: PubMed 12025884Cook 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.
- Background: PubMed 26581107Ye 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Genevieve Belleville, Ph.D. principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Managed Online Treatment and Therapist-Assisted Online Treatment in people with Post Traumatic Stress Disorder and Insomnia Disorder, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-traumatic Stress Disorder Symptoms (time frame: Pre-treatment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05811897, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.