Online Treatment Platform for Traumatic Stress Disorders

Overseen By Jessica Lebel, M.A.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Disqualifiers: Bipolar, Psychotic disorder, High suicidal risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 25 weeks

204 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{2 3 4 5 6}

How 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. ^{1 2 3 4 5}

Research Team

Genevieve Belleville, Ph.D.

Principal Investigator

Laval University

Eligibility 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

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.

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

Treatment Details

Interventions

• Self-Managed Online Treatment
• Therapist-Assisted Online Treatment

Trial Overview 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.

Participant Groups

Group I: Self-Managed Online Treatment Experimental Treatment 1 Intervention

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

Group II: Therapist-Assisted Online Treatment Active Control 1 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

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Ministère de la Justice, Québec

Collaborator

Trials

1

Recruited

200+

Findings from Research

An 8-week web-based cognitive behavioral therapy program combined with mindfulness and yoga showed significant reductions in PTSD symptoms (effect size d=1.60), depression, anxiety, and improvements in mindfulness among 22 participants aged 18-35.

Participants also exhibited a notable decrease in peak pupil dilation, indicating healthier autonomic functioning, although heart rate variability did not show significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Cognitive Behavioral Therapy, Mindfulness Meditation, and Yoga Intervention for Posttraumatic Stress Disorder: Single-Arm Experimental Clinical Trial. Kirk, MA., Taha, B., Dang, K., et al.[2022]

A 10-week Internet-based cognitive behavioral treatment for PTSD, involving 16 participants, showed clinically significant reductions in PTSD severity, indicating its effectiveness as a treatment option.

Participants reported high levels of satisfaction with the program and a strong therapeutic alliance with their online therapist, suggesting that this method of treatment is both accessible and well-received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A therapist-assisted Internet-based CBT intervention for posttraumatic stress disorder: preliminary results. Klein, B., Mitchell, J., Gilson, K., et al.[2022]

Minimally guided internet-based cognitive behavior therapy (iCBT) for PTSD showed significant reductions in symptom severity in both a randomized control trial (21 participants) and an open trial (117 participants), with effect sizes indicating moderate to large improvements.

The iCBT group maintained their symptom improvements at a 3-month follow-up, suggesting its potential effectiveness, although the randomized control trial's between-group comparison did not reach statistical significance, indicating the need for further research on clinician support levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered cognitive behaviour therapy for post-traumatic stress disorder: a randomised controlled trial and outcomes in routine care. Allen, AR., Smith, J., Hobbs, MJ., et al.[2022]

In an 8-week trial involving 45 service members with PTSD, self-management cognitive behavior therapy (CBT) showed significant reductions in PTSD symptoms and depression compared to supportive counseling.

One-third of participants who completed the self-management CBT achieved high-end state functioning at 6 months, suggesting it could be an effective treatment option for those with limited access to traditional therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled proof-of-concept trial of an Internet-based, therapist-assisted self-management treatment for posttraumatic stress disorder. Litz, BT., Engel, CC., Bryant, RA., et al.[2019]

Guided internet-based cognitive behavioral therapy with a trauma focus (CBT-TF) was found to be non-inferior to traditional face-to-face CBT-TF for treating mild to moderate PTSD, based on a study involving 196 adults over 16 weeks.

The internet-based therapy was significantly cheaper and well-accepted by participants, suggesting it could be a viable first-line treatment option for PTSD following a single traumatic event.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided, internet based, cognitive behavioural therapy for post-traumatic stress disorder: pragmatic, multicentre, randomised controlled non-inferiority trial (RAPID). Bisson, JI., Ariti, C., Cullen, K., et al.[2023]

The study evaluated a 5-week therapist-guided internet-based cognitive-behavioral therapy (iCBT) for 37 service members with PTSD, but found that improvements in PTSD symptoms were small and not statistically significant.

While there were small significant improvements in anxiety levels from pre-treatment to follow-up, the high dropout rate of 32.3% highlights challenges in treatment engagement among military personnel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an internet-based intervention for service members of the German armed forces with deployment-related posttraumatic stress symptoms. Niemeyer, H., Knaevelsrud, C., Schumacher, S., et al.[2020]

References

1. Canada pubmed.ncbi.nlm.nih.gov

A Web-Based Cognitive Behavioral Therapy, Mindfulness Meditation, and Yoga Intervention for Posttraumatic Stress Disorder: Single-Arm Experimental Clinical Trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A therapist-assisted Internet-based CBT intervention for posttraumatic stress disorder: preliminary results. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Internet-delivered cognitive behaviour therapy for post-traumatic stress disorder: a randomised controlled trial and outcomes in routine care. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized, controlled proof-of-concept trial of an Internet-based, therapist-assisted self-management treatment for posttraumatic stress disorder. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Guided, internet based, cognitive behavioural therapy for post-traumatic stress disorder: pragmatic, multicentre, randomised controlled non-inferiority trial (RAPID). [2023]

6. England pubmed.ncbi.nlm.nih.gov

Evaluation of an internet-based intervention for service members of the German armed forces with deployment-related posttraumatic stress symptoms. [2020]