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

NCT05670405 | Completed

• 1 other identifier: 2022-0083-E
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychological Trauma

Outcome Measures

Primary Outcomes (1)

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

  The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The self-report rating scale is 0-4 for each symptom. The min and max values are 0 and 80, with higher scores indicating worse outcome.

  At baseline, week 8 and week 16

Secondary Outcomes (3)

• Change in Clinician-Administered Post-Traumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Past Month score (CAPS-5 Past Month) score

  At baseline, week 8 and week 16

• Change in Difficulties in Emotion Regulation Scale (DERS-18) score

  At baseline, week 8 and week 16

• Change in Short Self-Compassion Scale (Short SCS) score

  At baseline, week 8 and week 16

Other Outcomes (8)

• Change in Health Service Utilization Questionnaire responses

  At baseline and week 16

• General Internet Attitude Scale

  Baseline

• Health Service Research Question Measures - Recruitment Data

  Through study completion, an average of 1 year

Study Arms (2)

Trauma PORTAL Intervention

EXPERIMENTAL

The treatment group will complete the Trauma PORTAL intervention in 9 weeks. The participants will be asked to complete clinical measures at baseline, 8 weeks, and 16 weeks.

Other: The Trauma PORTAL

Care-as-Usual

NO INTERVENTION

The control group will receive care-as-usual, remaining on the waitlist for the regular TTP R\&R groups. Participants in the CUC group will be asked to complete clinical measures at time points corresponding to the ITC group's baseline (prior to starting week one) and post-intervention (i.e. primary endpoint, end of week 8). Both groups will complete the clinical measures eight weeks later (16-week time point).

Interventions

The Trauma PORTAL OTHER

Participants will have 9 weeks to complete the 8 modules which each take on average 45 minutes to complete. Each module consists of psychoeducational handouts, videos, interactive exercises, and discussion topics that has been adapted from the R\&R curriculum. The participants will also receive a pdf of the handouts from the modules, which can be used to take notes or refer back to in the future. There will be an optional 60-minute weekly virtual group session for participants to engage with other participants in their group and for group facilitator providers to discuss the materials covered and answer any questions. Participants will join a Zoom video group visit to access the group. Each weekly group will be facilitated by 2 clinicians specializing in trauma-focused therapy within the WCH TTP who have extensive experience with in-person and virtual synchronous R\&R.

Trauma PORTAL Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's College Hospital: lead

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S1B2, Canada

Location

MeSH Terms

Conditions

Psychological Trauma

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Dana C. Ross, MD, MSc

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist, Trauma Therapy Program, Women's College Hospital

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: January 4, 2023
• Study Start: January 16, 2023
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

CA (1)