Trauma PORTAL Intervention for Psychological Trauma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Psychological TraumaThe Trauma PORTAL - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Psychological Trauma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Through study completion, an average of 1 year

Week 16
Change in Health Service Utilization Questionnaire responses
Week 16
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
Change in Difficulties in Emotion Regulation Scale (DERS-18) score
Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score
Change in Short Self-Compassion Scale (Short SCS) score
At week 8
Acceptability of intervention in the target population
Baseline
Agoraphobia as diagnosed by the Mini International Neuropsychiatric Interview (MINI)
Alcohol Use Disorder as diagnosed by the Mini International Neuropsychiatric Interview (MINI)
General Internet Attitude Scale
Generalized Anxiety as diagnosed by the Mini International Neuropsychiatric Interview (MINI)
Major Depressive Episode & Disorder as diagnosed by the Mini International Neuropsychiatric Interview (MINI)
Obsessive-Compulsive Disorder as diagnosed by the Mini International Neuropsychiatric Interview (MINI)
Panic Disorder as diagnosed by the Mini International Neuropsychiatric Interview (MINI)
Social Anxiety as diagnosed by the Mini International Neuropsychiatric Interview (MINI)
Substance Use Disorder as diagnosed by the Mini International Neuropsychiatric Interview (MINI)
Week 8
Iterative Feedback Form
Year 1
Health Service Research Question Measures - Adherence Data
Health Service Research Question Measures - Healthy System Implications Data
Health Service Research Question Measures - Recruitment Data
Health Service Research Question Measures - Safety Data

Trial Safety

Trial Design

2 Treatment Groups

Care-as-Usual
1 of 2
Trauma PORTAL Intervention
1 of 2

Active Control

Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: Trauma PORTAL Intervention · No Placebo Group · N/A

Trauma PORTAL Intervention
Other
Experimental Group · 1 Intervention: The Trauma PORTAL · Intervention Types: Other
Care-as-UsualNoIntervention Group · 1 Intervention: Care-as-Usual · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year

Who is running the clinical trial?

Women's College HospitalLead Sponsor
92 Previous Clinical Trials
37,072 Total Patients Enrolled
Dana C. Ross, MD, MScPrincipal InvestigatorWomen's College Hospital

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with PTSD using the MINI Module H.
You must have access to a suitable device and internet connection in order to utilize the intervention.
You are a suitable candidate for Trauma PORTAL intervention, as determined by evaluation with a TTP Therapist.
Participants will be excluded from the study if there is a clinical assessment of self-regulation difficulties, cognitive impairments that would inhibit comprehension and processing, significant case management requirements which preclude asynchronous online group therapy, or any other clinically relevant condition deemed inappropriate by an assessing TTP therapist.
You are 18 years or older.
You have reported any form of physical, sexual, emotional or neglectful childhood trauma experienced prior to the age of 18.
You have participated in the Trauma Therapy Program orientation at WCH.