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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

Study 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

Primary outcome measure(s)

• The Posttraumatic stress disorder checklist 5 (PCL-5) — Change from pre intervention to immediately post intervention
  Self rated PTSD-symptoms. Minimum value 0, maximum value 80, where higher values indicate more PTSD symptoms.
• The Posttraumatic stress disorder checklist 5 (PCL-5) — Change from pre intervention to 6 months post intervention
  Self rated PTSD-symptoms. Minimum value 0, maximum value 80, where higher values indicate more PTSD symptoms.
• The Posttraumatic stress disorder checklist 5 (PCL-5) — Change from pre intervention to 12 months post intervention
  Self rated PTSD-symptoms. Minimum value 0, maximum value 80, where higher values indicate more PTSD symptoms.

Trial sites (1)

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