Post-Traumatic Stress Disorder (PTSD) Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Karolinska Institutet
RECRUITING
Stockholm
Contact Information
Primary
Sigrid Salomonsson, PhD
Sigrid.salomonsson@ki.se
0708442283
Backup
Johan Lundin, PhD student
Johan.lundin.1@ki.se
Time Frame
Start Date: 2023-03-10
Estimated Completion Date: 2027-10-10
Participants
Target number of participants: 160
Treatments
Experimental: Blended Trauma focused Cognitive Behavioral Therapy (B-Tf-CBT)
B-Tf-CBT shares key features with Internet-based CBT (I-CBT) in that it is based on a digital support accessible to the patient. This digital support equips blended treatment with the same proposed advantages as I-CBT in terms of improving treatment accessibility, adherence, and reducing therapist-time. In addition, incorporating 6 biweekly face-to-face sessions to facilitate and augment delivery of more demanding components of TF-CBT such as memory exposure.
Active_comparator: Prolonged exposure
Gold standard Tf-CBT Prolonged exposure will constitute the control condition. Prolonged exposure will be delivered by trained therapists under supervision adhering to the evidence based manual delivered face-to-face over 9-15 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Capio Group, Region Stockholm, Stockholm University
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov