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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two online therapy options for individuals who have experienced sexual assault and are dealing with stress, depression, or insomnia. One group will use a self-managed online treatment platform, known as Self-Managed Cognitive Behavioral Therapy. The other group will receive weekly support from a therapist through Therapist-Assisted Online Treatment. The trial aims to determine which method is more effective and user-friendly in reducing symptoms. Ideal candidates are women who have experienced sexual assault after age 12, read and speak French, have internet access, and are experiencing post-traumatic stress, mild depression, or insomnia. Participants will provide feedback on their experience and progress throughout the trial. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance therapy options for others in similar situations.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that online cognitive behavioral therapy (CBT) is generally safe and well-tolerated for treating conditions like PTSD, anxiety, and depression. Studies have found that self-managed internet-based CBT is effective and acceptable to patients, meaning people usually feel comfortable using it, and it works well for many.

For therapist-assisted online treatment, evidence also supports its safety and effectiveness. Research indicates that having a therapist guide the treatment can lead to significant improvements in symptoms like PTSD, depression, and anxiety. This approach is also considered safe and well-accepted by users.

Both types of online treatments have been tested in various studies and are generally well-received, demonstrating good evidence of safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these online treatments for traumatic stress disorders because they offer a new level of accessibility and flexibility compared to traditional in-person therapy. The self-managed online treatment allows individuals to work through their symptoms at their own pace without needing to schedule regular appointments with a therapist, which can be a significant barrier for some. Meanwhile, the therapist-assisted online treatment provides the added benefit of professional support and encouragement, ensuring that participants can ask questions and receive guidance without the need for extensive in-person sessions. This approach not only enhances convenience but also makes it easier to quickly identify and assist those in urgent need, such as during a suicidal crisis.

What evidence suggests that this trial's treatments could be effective for traumatic stress disorders?

Research has shown that online cognitive behavioral therapy (CBT) can effectively treat symptoms of post-traumatic stress disorder (PTSD), making it a promising option for individuals who have experienced sexual assault. In this trial, participants may receive Self-Managed Online Treatment. Studies have found that self-guided online CBT can be as effective as traditional in-person therapy for mild to moderate PTSD. This method not only increases therapy accessibility but also provides users with a sense of emotional safety.

Alternatively, participants may receive Therapist-Assisted Online Treatment. When a therapist is involved in online treatment, research indicates significant improvements in PTSD, depression, and anxiety symptoms, even with limited weekly contact. Therapist-assisted online CBT has proven effective in various trauma cases, offering extra support to help participants through their healing journey. Together, these approaches offer flexible and potentially powerful tools to manage the psychological effects of trauma. ^{4 5 6 7 8}

Who Is on the Research Team?

Genevieve Belleville, Ph.D.

Principal Investigator

Laval University

Are You a Good Fit for This Trial?

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

Have experienced sexual assault after the age of 12

Have adequate Internet access

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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