Blended treatment for PTSD using computer-assisted therapy
Official title: 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
Run by Karolinska Institutet · NCT05758987 · Data updated 2026-11-12
This study is testing a new blended therapy for PTSD that combines online and in-person sessions to see if it works as well as the usual face-to-face treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm) |
| Status | Recruiting |
| Started | March 10, 2023 |
| Main results expected | October 10, 2026 |
| Study ends | October 10, 2027 |
| Registry record updated | December 26, 2025 |
| Trial ID | NCT05758987 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have a primary diagnosis of PTSD and can communicate in Swedish.
✕Probably not a fit
Patients with other primary psychological issues or those at moderate to severe risk of suicide may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial evaluates a new blended format of trauma-focused cognitive behavioral therapy (B-TF-CBT) for patients with post-traumatic stress disorder (PTSD) and compares its effectiveness to the established treatment, Prolonged Exposure (PE). The study will be conducted in outpatient clinics in Region Stockholm, Sweden, and will involve a randomized controlled design to assess various outcomes related to PTSD symptoms, depression, anxiety, sleep issues, quality of life, and overall functioning. Data will be collected at multiple time points, including before, during, immediately after, and 12 months post-treatment, using validated assessment tools. The primary goal is to determine if the blended treatment is non-inferior to the standard face-to-face therapy.
Why it matters
Potential benefit: If successful, this approach could provide a more accessible and flexible treatment option for patients with PTSD.
How similar studies have gone: Previous studies have shown promise for blended therapy approaches, but this specific method is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Other diagnosis or problem is assessed as primary to PTSD * Moderate to severe suicidal risk * PTSD from childhood trauma that the person cannot remember
Where it's running
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Karolinska Institutet
Stockholm, Sweden Recruiting
Study contacts
- Principal investigator: Sigrid Salomonsson, PhD — Karolinska institute, clinical neuroscience
- Study coordinator: Sigrid Salomonsson, PhD
- Email: Sigrid.salomonsson@ki.se
- Phone: 0708442283
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.