Actively Recruiting
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
Led by Karolinska Institutet · Updated on 2025-12-26
160
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
C
Capio Group
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Blended Treatment för PTSD: A New Format of Computer-Assisted Trauma-Focused Cognitive Behavioral Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- PTSD according to Diagnostic and Statistical Manual of mental disorders 5 as primary problem
- 18 years or older
- Basic knowledge of speaking and writing Swedish
- No other psychological treatment at the same time
- No ongoing threats or violence
- If on antidepressant medication, stable dose for at least 6 weeks before starting treatment
- Have access to the internet and a computer
- Willingness and ability to participate after receiving study information
You will not qualify if you...
- Other diagnosis or problem is assessed as primary to PTSD
- Moderate to severe suicidal risk
- PTSD from childhood trauma that the person cannot remember
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 9 to 15 weeks
Participants receive trauma-focused cognitive behavioral therapy either through a blended format combining internet-based modules with face-to-face sessions or through a standard face-to-face prolonged exposure therapy.
6 biweekly face-to-face sessions for blended treatment or regular face-to-face sessions over 9 to 15 weeks for prolonged exposure
Duration - 12 months post treatment
Participants complete outcome assessments to evaluate symptoms of PTSD, depression, anxiety, sleep, quality of life, and other measures at multiple time points following treatment.
Assessments at immediately post-treatment, 6 months, and 12 months post treatment
Trial Site Locations
Total: 1 location
1
Karolinska Institutet
Stockholm, Sweden
Actively Recruiting
Research Team
S
Sigrid Salomonsson, PhD
J
Johan Lundin, PhD student
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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