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

Inclusion Criteria8

  • 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 Criteria3

  • Other diagnosis or problem is assessed as primary to PTSD
  • Moderate to severe suicidal risk
  • PTSD from childhood trauma that the person cannot remember

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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