Online Treatment Platform for Traumatic Stress Disorders
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Laval University
Disqualifiers: Bipolar, Psychotic disorder, High suicidal risk, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on online therapy for traumatic stress, so it's best to discuss your medications with the trial team.
What data supports the effectiveness of this treatment for traumatic stress disorders?
Research shows that online cognitive behavioral therapy (CBT) with therapist support can significantly reduce PTSD symptoms. Studies found that internet-based CBT is as effective as face-to-face therapy for mild to moderate PTSD and that web-based CBT with mindfulness and yoga is a viable treatment option.
12345Is online treatment for traumatic stress disorders safe for humans?
Research on online cognitive behavioral therapy (CBT) for post-traumatic stress disorder (PTSD) shows that it is generally safe for humans, with participants experiencing significant reductions in PTSD symptoms and moderate tolerance of the program content.
23456How is the Online Treatment Platform for Traumatic Stress Disorders different from other treatments?
This treatment is unique because it offers cognitive behavioral therapy (CBT) for PTSD through an online platform, allowing for self-management or therapist assistance via the internet, which can make it more accessible and convenient compared to traditional face-to-face therapy.
12345Eligibility Criteria
This trial is for women at least 18 years old who have experienced sexual assault after age 12, can read and speak French, and have internet access. They should show some post-traumatic stress symptoms, mild depression or subclinical insomnia but not be at high suicidal risk or currently receiving psychological treatment.Inclusion Criteria
I am 18 years old or older.
I identify as a woman, at least partially.
Have experienced sexual assault after the age of 12
+3 more
Exclusion Criteria
High suicidal risk, or any other condition requiring immediate intervention
I am currently seeing improvements from my mental health treatment.
I have a history of bipolar or psychotic disorder.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive online CBT treatment through the RESILIENT platform, either self-managed or therapist-assisted, to address post-traumatic stress, insomnia, and depression symptoms.
Up to 25 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments of post-traumatic stress disorder, insomnia, depression, and anxiety.
12 weeks
Post-treatment Evaluation
Participants complete a semi-structured interview and self-report questionnaires to evaluate the appreciation and acceptability of the online intervention.
Average of 30 weeks post last module
Participant Groups
The RESILIENT trial tests a self-managed online platform versus therapist-assisted online treatment to help victims of sexual assault cope with trauma, depression, and sleep issues. Participants will be randomly assigned to one of the two methods and evaluated over time.
2Treatment groups
Experimental Treatment
Active Control
Group I: Self-Managed Online TreatmentExperimental Treatment1 Intervention
Participants manage their treatment online without the assistance of a therapist.
Group II: Therapist-Assisted Online TreatmentActive Control1 Intervention
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).
Self-Managed Online Treatment is already approved in Canada for the following indications:
🇨🇦 Approved in Canada as Self-Managed Online Treatment for:
- Post-traumatic stress disorder (PTSD)
- Depression
- Insomnia
- Anxiety
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Laval UniversityQuébec, Canada
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Who Is Running the Clinical Trial?
Laval UniversityLead Sponsor
Ministère de la Justice, QuébecCollaborator
References
A Web-Based Cognitive Behavioral Therapy, Mindfulness Meditation, and Yoga Intervention for Posttraumatic Stress Disorder: Single-Arm Experimental Clinical Trial. [2022]Posttraumatic stress disorder (PTSD) is a debilitating, undertreated condition. The web-based delivery of cognitive behavioral therapy supplemented with mindfulness meditation and yoga is a viable treatment that emphasizes self-directed daily practice.
A therapist-assisted Internet-based CBT intervention for posttraumatic stress disorder: preliminary results. [2022]Posttraumatic stress disorder (PTSD) is a debilitating mental health condition frequently associated with psychiatric comorbidity and diminished quality of life, and it typically follows a chronic, often lifelong, course. Previous research has shown that trauma-related psychopathology (but not necessarily clinical PTSD) can be effectively treated via the Internet. This study is the first of its kind to report on the online treatment of patients with a Diagnostic and Statistical Manual of Mental Disorders (fourth edition) clinical diagnosis of PTSD with therapist support by e-mail only. Preliminary findings are presented of an open trial involving a 10-week Internet-based therapist-assisted cognitive behavioural treatment for PTSD (PTSD Online). Pre and posttreatment measures of PTSD and related symptomatology were compared for 16 participants with a variety of trauma experiences. Participants showed clinically significant reductions in PTSD severity and symptomatology, moderate tolerance of the program content, and high therapeutic alliance ratings. No significant change was found on measures of more general psychological symptoms. The results suggest that PTSD Online appears to be an effective and accessible clinical treatment for people with a confirmed PTSD diagnosis.
Internet-delivered cognitive behaviour therapy for post-traumatic stress disorder: a randomised controlled trial and outcomes in routine care. [2022]Despite its potential scalability, little is known about the outcomes of internet-based cognitive behaviour therapy (iCBT) for post-traumatic stress disorder (PTSD) when it is provided with minimal guidance from a clinician.
A randomized, controlled proof-of-concept trial of an Internet-based, therapist-assisted self-management treatment for posttraumatic stress disorder. [2019]The authors report an 8-week randomized, controlled proof-of-concept trial of a new therapist-assisted, Internet-based, self-management cognitive behavior therapy versus Internet-based supportive counseling for posttraumatic stress disorder (PTSD).
Guided, internet based, cognitive behavioural therapy for post-traumatic stress disorder: pragmatic, multicentre, randomised controlled non-inferiority trial (RAPID). [2023]To determine if guided internet based cognitive behavioural therapy with a trauma focus (CBT-TF) is non-inferior to individual face-to-face CBT-TF for mild to moderate post-traumatic stress disorder (PTSD) to one traumatic event.
Evaluation of an internet-based intervention for service members of the German armed forces with deployment-related posttraumatic stress symptoms. [2020]The present study was designed to evaluate the efficacy of a therapist-guided internet-based cognitive-behavioral therapy (iCBT) intervention for service members of the German Armed Forces with posttraumatic stress disorder (PTSD). The iCBT was adapted from Interapy, a trauma-focused evidence-based treatment based on prolonged exposure and cognitive restructuring. It lasted for 5 weeks and included 10 writing assignments (twice a week). The program included a reminder function if assignments were overdue, but no multimedia elements. Therapeutic written feedback was provided asynchronously within one working day.