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RECRUITING
NCT05758987
NA

Blended Treatment för PTSD: A New Format of Computer-Assisted Trauma-Focused Cognitive Behavioral Therapy

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2023-03-10

Completion Date

2027-10-10

Last Updated

2025-12-26

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Blended 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.

BEHAVIORAL

Prolonged exposure

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

Locations (1)

Karolinska Institutet

Stockholm, Sweden