RecruitingNot ApplicableNCT05758987

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


Sponsor

Karolinska Institutet

Enrollment

160 participants

Start Date

Mar 10, 2023

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a blended treatment for PTSD that combines online, computer-assisted therapy with in-person sessions with a therapist. Researchers want to find out if this mixed-format approach is an effective way to deliver trauma-focused cognitive behavioral therapy (CBT). **You may be eligible if...** - You have been diagnosed with PTSD as your primary mental health concern - You are 18 years or older - You speak and write Swedish - You are not currently receiving other psychological treatment - If you take antidepressants, you have been on a stable dose for at least 6 weeks - You have access to a computer and the internet **You may NOT be eligible if...** - Another condition (not PTSD) is the main issue - You have moderate to severe suicidal thoughts - You are experiencing ongoing threats or violence - You have severe alcohol or drug dependence, active psychosis, or severe personality disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALBlended Trauma focused Cognitive Behavioral Therapy (B-Tf-CBT)

A trauma-focused CBT where internet-based treatment is blended with face-to-face sessions with a therapist.

BEHAVIORALProlonged exposure

A gold standard trauma-focused CBT delivered with face-to-face sessions with a therapist.


Locations(1)

Karolinska Institutet

Stockholm, Sweden

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NCT05758987


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