Testing Blended Trauma-Focused Cognitive Behavioral Therapy Compared to Standard Prolonged Exposure for PTSD A Randomized Trial in Routine Clinical Care

What this Trial Is About

Researchers are evaluating a new blended trauma-focused cognitive behavioral therapy B-TF-CBT for adults with post-traumatic stress disorder PTSD, comparing it to the established face-to-face prolonged exposure PE therapy. The study aims to determine if B-TF-CBT, which combines internet-based modules with face-to-face sessions, is not less effective than PE in reducing PTSD symptoms immediately after treatment and at 6 and 12 months follow-up. This trial is conducted in outpatient clinics within the Stockholm region. Participants receive either the blended B-TF-CBT, which includes digital support and six biweekly face-to-face therapy sessions over 9-15 weeks, or the standard PE treatment delivered face-to-face by trained therapists over the same duration. Both treatments follow structured protocols, and therapists adherence and competence are monitored through checklists and session recordings. The study collects extensive data on symptoms, treatment engagement, and any adverse events. Throughout the trial, participants will complete questionnaires assessing PTSD symptoms, depression, anxiety, insomnia, social and work functioning, and quality of life before, during, immediately after treatment, and at 6 and 12 months post-treatment. The main measure is the PTSD Checklist PCL-5. Researchers will analyze data for symptom changes and treatment satisfaction, using statistical models to compare the two therapies. Safety, adherence, and possible concurrent treatments are also tracked for up to a year after treatment.

Blended Treatment för PTSD: A New Format of Computer-Assisted Trauma-Focused Cognitive Behavioral Therapy