NCT05758987 Blended Treatment för PTSD: A New Format of Computer-Assisted Trauma-Focused Cognitive Behavioral Therapy
| NCT ID | NCT05758987 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | PTSD |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2023-03-10 |
| Primary Completion | 2026-10-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2023-03-10 with a primary completion date of 2026-10-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Sigrid Salomonsson, PhD
PRINCIPAL INVESTIGATOR
Karolinska institute, clinical neuroscience
Frequently Asked Questions
Who can join the NCT05758987 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PTSD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05758987 currently recruiting?
Yes, NCT05758987 is actively recruiting participants. Contact the research team at Sigrid.salomonsson@ki.se for enrollment information.
Where is the NCT05758987 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT05758987 clinical trial?
NCT05758987 is sponsored by Karolinska Institutet. The principal investigator is Sigrid Salomonsson, PhD at Karolinska institute, clinical neuroscience. The trial plans to enroll 160 participants.
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