Blended Treatment för PTSD: A New Format of Computer-Assisted Trauma-Focused Cognitive Behavioral Therapy
Evaluation of Blended CBT for PTSD in Regular Care: A New Format of Computer-Assisted Trauma-Focused Cognitive Behavioral Therapy: A Randomized Controlled Non-inferiority Trial
Karolinska Institutet
160 participants
Mar 10, 2023
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria8
- 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
- No ongoing threats or violence
- If antidepressant medication, stable dose 6 weeks before starting treatment
- Have access to the internet and a computer
- Willingness/ability to participate after receiving information about what participation entails
Exclusion Criteria3
- Other diagnosis or problem is assessed as primary to PTSD
- Moderate to severe suicidal risk
- PTSD from childhood trauma that the person cannot remember
Interventions
A trauma-focused CBT where internet-based treatment is blended with face-to-face sessions with a therapist.
A gold standard trauma-focused CBT delivered with face-to-face sessions with a therapist.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05758987