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

NCT05758987 | Recruiting

• 1 other identifier: 2020-07130
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 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?
2. 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. 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?

Conditions

PTSD; CBT

Outcome Measures

Primary Outcomes (3)

• The Posttraumatic stress disorder checklist 5 (PCL-5)

  Self rated PTSD-symptoms. Minimum value 0, maximum value 80, where higher values indicate more PTSD symptoms.

  Change from pre intervention to immediately post intervention

• The Posttraumatic stress disorder checklist 5 (PCL-5)

  Self rated PTSD-symptoms. Minimum value 0, maximum value 80, where higher values indicate more PTSD symptoms.

  Change from pre intervention to 6 months post intervention

• The Posttraumatic stress disorder checklist 5 (PCL-5)

  Self rated PTSD-symptoms. Minimum value 0, maximum value 80, where higher values indicate more PTSD symptoms.

  Change from pre intervention to 12 months post intervention

Secondary Outcomes (43)

• Clinician-administered PTSD Scale for DSM-5 (CAPS-5)

  1 week post intervention

• Clinician-administered PTSD Scale for DSM-5 (CAPS-5)

  12 months post intervention

• Patient Health Questionnaire (PHQ-9)

  Change from pre intervention to immediately post intervention

• Patient Health Questionnaire (PHQ-9)

  Change from pre intervention to 6 months post intervention

• Patient Health Questionnaire (PHQ-9)

  Change from pre intervention to 12 months post intervention

Study Arms (2)

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

EXPERIMENTAL

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.

Behavioral: Blended Trauma focused Cognitive Behavioral Therapy (B-Tf-CBT)

Prolonged exposure

ACTIVE COMPARATOR

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.

Behavioral: Prolonged exposure

Interventions

Blended Trauma focused Cognitive Behavioral Therapy (B-Tf-CBT) BEHAVIORAL

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

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

Prolonged exposure BEHAVIORAL

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

Prolonged exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Capio Group: collaborator
• Stockholm University: collaborator
• Region Stockholm: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Sigrid Salomonsson, PhD

  Karolinska institute, clinical neuroscience

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sigrid Salomonsson, PhD

CONTACT

0708442283; Sigrid.salomonsson@ki.se

Johan Lundin, PhD student

CONTACT

Johan.lundin.1@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor of secondary outcome CAPS will be masked to participant allocation at post and follow-up assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, PhD

Model Details: A randomized controlled non-inferiority trial evaluating if the new blended Tf-CBT is non inferior to the gold standard PTSD treatment Prolonged exposure. The trial is a multicenter study conducted at 3-6 sites. Participants are individually randomized in blocks of 2-4 at each site.

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 8, 2023
• Study Start: March 10, 2023
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): October 10, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)