Studies

Interventional Recruiting

NCT07388004 on ClinicalTrials.gov

Group Therapy for Major Depression: Comparing Expectation-Focused and Reward-Focused Psychotherapy Approaches

Official title: Rewiring Expectations and Amplifying Rewards: A Study Protocol for a Randomized Controlled Trial of Mechanism-Based Group Psychotherapy for Major Depressive Disorder

  • Sponsor: Philipp University of Marburg
  • Collaborators: German Research Foundation
  • Enrollment: 150 (Estimated)
  • Study start: 2025-10-13 (Actual)
  • Primary completion: 2027-12-31 (Estimated)
  • Study completion: 2028-06-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Participants will be randomly assigned in equal proportions to one of three parallel groups: EFPI, REACT, or waiting-list control.
  • Masking: Single (Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

Major depressive disorder (MDD) is one of the most common psychiatric conditions and often remains difficult to treat effectively. Many patients continue to experience residual symptoms or relapse even after receiving established forms of psychotherapy. This study tests whether targeting specific psychological mechanisms can improve outcomes for people with depression. We compare two novel group therapies: (1) Expectation-Focused Psychotherapeutic Intervention (EFPI), which aims to modify rigid, negative expectations that maintain depressive symptoms, and (2) Reward Enhancement and Activation Therapy (REACT), which focuses on increasing sensitivity to positive experiences and strengthening reward-related learning. Both are delivered in a group format to foster peer support and shared learning.

A total of 150 adults with a current MDD diagnosis will be randomly assigned to EFPI, REACT, or a waiting-list control. Participants in the intervention groups receive 10 group sessions over five weeks. Waiting-list participants complete baseline and 3-month follow-up assessments before being offered standard treatment options.

Clinical outcomes are assessed at baseline, immediately after treatment, and at 3- and 6-month follow-ups (for the intervention groups). Primary outcomes are reductions in depressive symptoms measured by clinician ratings and self-report questionnaires. Secondary outcomes include changes in expectation processes and reward sensitivity.

In addition, functional MRI (fMRI) tasks examine brain mechanisms related to expectation updating and reward processing pre- and post-intervention, to help identify neural changes that may underlie symptom improvement.

By directly addressing dysfunctional expectations and reduced reward sensitivity, this study seeks to provide evidence for more targeted psychotherapeutic approaches. If successful, the results may support more personalized treatments and better long-term outcomes in MDD.

Conditions

  • Major Depressive Disorder (MDD)

Intervention / Treatment

  • Behavioral: Expectation-Focused Psychotherapeutic Intervention
  • Behavioral: Reward Enhancement and Activation Therapy

Primary Outcome Measures

  • Change in Depressive Symptoms (Beck Depression Inventory-II) (Baseline, post-treatment (5 weeks), 3-month and 6-month follow-ups)
    Change in depressive symptom severity assessed with the Beck Depression Inventory-II (BDI-II), a 21-item self-report questionnaire measuring cognitive, affective, and somatic symptoms of depression. Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms. The primary endpoint is the change from baseline to post-treatment (5 weeks). Symptom stability and maintenance will be examined at follow-up assessments.

Countries

Germany

Locations and Investigators

  • Philipps-University Marburg, Marburg, Germany (Recruiting)
    • Masia Fernanda Hoffmann, M.Sc.
    • Lukas Kirchner, Dr.

Study Officials