Ignite Creation Date:
2024-05-06 @ 6:28 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05670405
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2022-11-30
Brief Title:
The Trauma PORTAL Project a Virtual Asynchronous Treatment for Interpersonal Trauma
Sponsor:
Womens College Hospital
Organization:
Womens College Hospital
Study Overview
Official Title:
The Trauma PORTAL Project A Randomized Controlled Trial of a Virtual Asynchronous Psychoeducational Psychotherapy Treatment for Survivors of Childhood Interpersonal Trauma
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Womens 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 RR 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 RR consisting of 8 modules called the Trauma PORTAL previously called electronic Resourced and Resilient or e-RR 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 eRR 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 RR in the Trauma Therapy Program TTP at Womens 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 andor 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 RR 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 RR 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
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 RR 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 RR 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None