Efficacy of a hybrid psychoeducational and skills-based therapy (Trauma PORTAL) for adults with PTSD related to childhood interpersonal trauma: a parallel-group, randomised controlled trial.

Background: Many adults with posttraumatic stress disorder (PTSD) related to childhood interpersonal trauma (CIT) face substantial barriers to care and limited access to trauma-specific treatment. We evaluated the efficacy of the Trauma PORTAL (Providing Online tRauma Therapy using an Asynchronous Learning platform), a trauma-focused hybrid therapy integrating self-paced psychoeducational and skills-based modules and virtual therapist-led group sessions, to reduce PTSD symptoms in adults with a history of CIT. Methods: This randomised, assessor-masked, controlled, parallel-group trial was conducted at a single site in Ontario, Canada. Participants (≥18 years) with a history of CIT were recruited within an ambulatory urban hospital and met criteria for PTSD based on the Mini-International Neuropsychiatric Interview (MINI). Participants were randomly assigned (1:1) to Trauma PORTAL (intervention; eight online modules and eight optional weekly 1-h virtual group sessions facilitated by two trauma therapists) or treatment as usual (control). The primary outcome was severity of PTSD symptoms assessed at 8 weeks relative to baseline, measured by self-report on the PTSD Checklist for DSM-5 (PCL-5). Outcomes were analysed in the intention-to-treat population using a linear mixed-effects model. Secondary outcomes included clinician-rated PTSD severity using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), emotion regulation, depression, anxiety, stress, and self-compassion. Individuals with lived experience of CIT were involved in the development of the Trauma PORTAL intervention, but not in the design of this trial. The trial was registered with ClinicalTrials.gov (NCT05670405). Findings: Between November 7, 2022, and October 6, 2023, 328 participants were screened for eligibility, and of these 183 (56%) provided consent and were enrolled. After 2 were lost to follow-up, 181 participants were randomly assigned to Trauma PORTAL (91 [50%]) or control (90 [50%]). At baseline, 147 (81%) participants were women, mean age was 40.8 years (SD 11.5), and 119 (66%) were White. Trauma PORTAL was superior to control in reducing PTSD symptoms, showing an adjusted mean difference (aMD) on the PCL-5 at week 8 of -7.08 (95% CI -11.55 to -2.61), corresponding to a moderate effect size (d = 0.44 [95% CI 0.12-0.76]). This effect was maintained at week 16 (aMD -7.00, 95% CI -11.83 to -2.18). No adverse events were reported. Interpretation: Trauma PORTAL reduced PTSD symptoms more than treatment as usual, supporting its potential as an effective and acceptable hybrid psychoeducation and skills-based therapy that may help expand access to trauma-focused care for adults with CIT. Further evaluation against established treatments is warranted. Funding: This project was supported by the WCHAMSG (Women's College Hospital Alternative Medical Staff Group) Innovation Fund of the Alternative Funding Plan for the Academic Health Sciences Centres of Ontario, and the Department of Psychiatry, Women's College Hospital.