About this trial
A Randomized Controlled Non-inferiority Trial testing if the new experimental Blended Trauma focused cognitive behavioral therapy (B-TF-CBT) for post traumatic stress disorder (PTSD), is non-inferior to gold standard control treatment Prolonged Exposure (PE).
Research question and hypothesis
Primary
1. Is bTF-CT non-inferior to prolonged exposure (PE) when delivered in routine clinical care in terms of PTSD symptoms on the PCL-5 post-treatment?
Secondary: 2. Is bTF-CT non-inferior to prolonged exposure (PE) when delivered in routine clinical care in terms of PTSD symptoms on the PCL-5 at 6 and 12 months follow up? 3. Are there significant differences between bTF-CT and PE when delivered in routine clinical care in terms of depression, anxiety, insomnia, functionality, complex PTSD, other PTSD-measures and treatment satisfaction post-treatment and at 6 and 12 months follow up?
The study will be conducted at 3-6 outpatient clinics in Region Stockholm, Sweden.
Eligibility criteria
Qualifiers
PTSD according to Diagnostic and Statistical Manual of mental disorders 5 as primary problem
≥ 18 years
Basic knowledge of speaking and writing Swedish
No other psychological treatment at the same time
Disqualifiers
Other diagnosis or problem is assessed as primary to PTSD
Moderate to severe suicidal risk
PTSD from childhood trauma that the person cannot remember
Trial design
Treatments tested in this trial
- Blended Trauma focused Cognitive Behavioral Therapy (B-Tf-CBT)
- Prolonged exposure
Treatment groups
Sponsors and collaborators
Karolinska Institutet
Lead sponsor
Capio Group
Collaborator
Stockholm University
Collaborator
Region Stockholm
Collaborator