Clinical trial NCT05670405: The Trauma PORTAL Project: a Virtual Asynchronous Treatment for Interpersonal Trauma
Official title: The Trauma PORTAL Project: A Randomized Controlled Trial of a Virtual Asynchronous Psychoeducational Psychotherapy Treatment for Survivors of Childhood Interpersonal Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Trauma
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The investigators aim to conduct a randomized controlled trial to determine the efficacy of the Trauma PORTAL intervention. The Trauma PORTAL is an asynchronous virtual multimedia version of the stage 1 trauma-focused psychoeducational psychotherapy group called Resourced \& Resilient (R\&R) in the Trauma Therapy Program (TTP) at Women's College Hospital (WCH). The TTP is a specialized trauma-focused therapy service for persons with childhood histories of trauma. The program offers confidential, time-limited and primarily group-based psychotherapy to adults who have experienced childhood interpersonal trauma, including physical, sexual, and emotional abuse and/or neglect that occurred between the ages of 0-18. The TTP comprises an interdisciplinary team of trauma therapists with backgrounds in psychiatry, psychotherapy, psychology, social work, and nursing.

The Trauma PORTAL intervention consists of 8 online modules that participants can complete at the participants own pace, with optional once-weekly "live" virtual sessions facilitated by trauma therapists in the TTP. The investigators specifically aim to measure clinical symptoms to generate estimates of the effect of the Trauma PORTAL intervention on clinical measures of PTSD, depression, anxiety, and emotion regulation compared to a care-as-usual condition. The investigators will also evaluate the intervention processes, including recruitment, retention, acceptability and adherence to inform spread and scale post-trial if the intervention is demonstrated to be effective.

Individuals will be recruited from the waitlist for the "live" synchronous virtual or in-person R\&R group in the TTP.

Individuals will be randomized to receive the Trauma PORTAL intervention (immediate treatment condition, ITC) or treatment as usual while on a waitlist (care-as-usual condition, CUC). Participants randomized to CUC will remain on the waitlist for live R\&R and complete clinical measures at the same time points as the ITC group. All participants will complete clinical measures at baseline, 8 weeks, and 16 weeks.

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: 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
timeFrame: At baseline, week 8 and week 16
measure: Change in Difficulties in Emotion Regulation Scale (DERS-18) score
timeFrame: At baseline, week 8 and week 16
measure: Change in Short Self-Compassion Scale (Short SCS) score
timeFrame: At baseline, week 8 and week 16
Other outcomes:
measure: Change in Health Service Utilization Questionnaire responses
timeFrame: At baseline and week 16
measure: General Internet Attitude Scale
timeFrame: Baseline
measure: Health Service Research Question Measures - Recruitment Data
timeFrame: Through study completion, an average of 1 year
measure: Health Service Research Question Measures - Adherence Data
timeFrame: Through study completion, an average of 1 year
measure: Health Service Research Question Measures - Safety Data
timeFrame: Through study completion, an average of 1 year
measure: Health Service Research Question Measures - Healthy System Implications Data
timeFrame: Through study completion, an average of 1 year
measure: Acceptability of intervention in the target population
timeFrame: At week 8
measure: Iterative Feedback Form
timeFrame: Once weekly for 8 weeks
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Dana C. Ross, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: