CompletedNot Applicable

The Trauma PORTAL Project: a Virtual Asynchronous Treatment for Interpersonal Trauma

Canada183 participantsStarted 2023-01-16

Plain-language summary

Virtual delivery of mental health care is an emerging strategy for increasing access and enhancing the delivery of mental health services; however, evidence that virtual interventions are an efficacious form of therapy is limited. An asynchronous virtual treatment program that allows patients to access program material at any time could be a widely accessible, cost-effective alternative to in-person or synchronous virtual group therapy. The Trauma Therapy Program (TTP) at Women's College Hospital (WCH) follows clinical guidelines for the treatment of complex post-traumatic stress disorder that recommend a staged approach to treatment for adults suffering from the sequelae of childhood interpersonal trauma (CIT). The initial stage is safety and stabilization; in TTP, this begins with the Resourced and Resilient (R\&R) group, a stage 1 trauma-focused psychoeducational psychotherapy group. Psychoeducational psychotherapy is a widely used approach to help patients understand the impact of trauma, challenge maladaptive behaviour patterns, learn safer coping skills and reduce trauma-related symptoms as part of a comprehensive approach to the treatment of PTSD. To address gaps in equitable access to trauma-focused care, the investigators developed the Trauma PORTAL: Providing Online tRauma Therapy using an Asynchronous Learning platform. The investigators developed an asynchronous virtual multimedia version of R\&R consisting of 8 modules, called the Trauma PORTAL; previously called electronic Resourced and Resilient or e-R\&R. The investigators then conducted an open-label pilot study where the Trauma PORTAL intervention was offered that included access to the asynchronous virtual modules, along with an optional weekly 1-hour synchronous virtual group that offers patients an opportunity to ask questions about content from the modules. Preliminary data from the investigators' open-label eR\&R pilot study demonstrates feasibility, usability, and acceptability, as well as a significant improvement in PTSD symptoms from pre- to post-group. This phase of the Trauma PORTAL project seeks to test the efficacy and further assess the intervention processes, including recruitment, retention, acceptability, and adherence to the Trauma PORTAL intervention through a randomized controlled trial.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged \> 18 years old; and * Self-report childhood interpersonal trauma (physical, sexual, emotional, neglect) prior to age 18; and * A diagnosis of PTSD aligned with the Mini International Neuropsychiatric Interview Module H; and * Access to appropriate device and internet connection to access the intervention; and * Attended an orientation session for the Trauma Therapy Program at WCH; and * Suitable for Trauma PORTAL intervention (confirmed by clinical assessment with a TTP Therapist)\* * Participants will not be included if, based on a clinical assessment with a TTP therapist, there is a concern that the participant has: (1) significant difficulty with self-regulation which make them unsuitable for an outpatient asynchronous intervention, (2) cognitive impairments that would impede understanding and processing of educational material, (3) significant case management needs that would result in lack of suitability for asynchronous online group therapy, or (4) for any other clinical reason, at the discretion of the assessing TTP therapist. Exclusion Criteria: * Have had active alcohol or substance use disorder in the past 3 months; or * Have active symptoms of mania or psychosis, or active suicidal ideation; or * Have had psychiatric hospitalization in the past 6 months; or * Are unable to complete study procedures in English (intervention not yet translated) * Previously completed an R\&R group with an approved provider

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score

Timeframe: At baseline, week 8 and week 16

Trial details

NCT IDNCT05670405

SponsorWomen's College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-20

View on ClinicalTrials.gov More Psychological Trauma trials