Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 11, 2025
Date Accepted: Nov 29, 2025
Clinical and Cost-Effectiveness of Blended Cognitive Behavioral Therapy or Psychodynamic Therapy versus Face-To-Face Psychotherapy for Depression (BLENDED Study): Protocol for a pragmatic, multicenter, assessor-blinded randomized controlled non-inferiority trial
ABSTRACT
Background:
Depression is a highly prevalent disorder. There is still a considerable treatment gap because of capacity issues across clinical services, which create barriers to access to effective psychological therapies. In addition, many individuals with depression do not seek treatment, and waiting lists for psychotherapy are typically very long. Blended psychotherapy, which combines online components and in-person sessions, may help bridge the treatment gap as a cost-effective intervention that complements other types of treatment for depression, as it may reduce therapist time and potentially lower the threshold for people to seek treatment for their depression.
Objective:
This study sets out to investigate the clinical effectiveness and cost-effectiveness of blended psychodynamic therapy (PDT) and cognitive behavioral therapy (CBT) for depression compared with face-to-face (FTF) PDT and CBT from baseline to 12-month follow-up in adults diagnosed with major depressive disorder (MDD) (n=504) in a pragmatic, single-blind, multi-site, non-inferiority trial.
Methods:
Patients will also be followed up until 2 years after the end of treatment. In addition, potential moderators and mechanisms of change will be investigated. A qualitative study will explore the subjective experiences of both patients and therapists associated with blended treatment.
Results:
Inclusions started on April 1, 2019, and were seriously delayed because of COVID-19 restrictions as detailed in the Protocol Amendments section. The trial is currently still ongoing; recruitment ended on December 2, 2024, and all assessments should be completed by the end of September 2026.
Conclusions:
This trial promises to inform decisions concerning the implementation of blended versus FTF therapy for individuals with depression in routine clinical care. Clinical Trial: ClinicalTrials.gov NCT04337242; https://clinicaltrials.gov/study/NCT04337242
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