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Recruiting NCT05670405

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

Conditions: Psychological Trauma

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 200
Sponsor: Women's College Hospital

Location: Canada

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.

Eligibility Criteria

Inclusion Criteria:Aged > 18 years old; andSelf-report childhood interpersonal trauma (physical, sexual, emotional, neglect) prior to age 18; andA diagnosis of PTSD aligned with the Mini International Neuropsychiatric Interview Module H; andAccess to appropriate device and internet connection to access the intervention; andAttended an orientation session for the Trauma Therapy Program at WCH; andSuitable 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; orHave active symptoms of mania or psychosis, or active suicidal ideation; orHave had psychiatric hospitalization in the past 6 months; orAre unable to complete study procedures in English (intervention not yet translated)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05670405). StuddyBuddy aggregates publicly available trial information.