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

NCT05758987 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-12-26

No results posted yet for this 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.

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.

Sponsors & Collaborators

  • Capio Group

    collaborator OTHER

  • Stockholm University

    collaborator OTHER

  • Region Stockholm

    collaborator OTHER_GOV

  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Sigrid Salomonsson, PhD · Karolinska institute, clinical neuroscience

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-10
Primary Completion
2026-10-10
Completion
2027-10-10

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05758987 on ClinicalTrials.gov