Clinical Trial

FEEL-GOOD: A Multicenter Trial of a Mindfulness-Based Group Therapy in Young Adults With Early Psychosis

Study acronym: FEEL-GOOD
Recruiting
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Summary
FEEL-GOOD is a prospective multi-site single-blinded randomized controlled trial in young inpatients with acute early psychosis. Participants are randomized 1:1 to FEEL-GOOD plus treatment as usual (TAU) or TAU alone. The intervention consists of one individual preparatory session and eight modularized group sessions delivered over four weeks involving four to eight participants at each session and including practice and homework tasks. Outcomes are assessed at baseline, 4 weeks post-intervention, and 6 months follow-up, with the primary outcome being observer-rated total psychopathology as measured with the assessed by the total score of the Positive and Negative Syndrome Scale (PANSS) post-treatment (4 weeks post baseline).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-06-09.
Trial Details
NCT Number NCT07645443
Lead Sponsor Stephanie Mehl
Collaborators: German Research Foundation, Central Institute of Mental Health, Mannheim, Ludwig-Maximilians - University of Munich, Charite University, Berlin, Germany, Vivantes Klinikum am Urban, Philipps University Marburg, University of Cologne, Universitätsklinikum Hamburg-Eppendorf, University Hospital Augsburg
Conditions Delusional Disorder, Brief Psychotic Disorder, Schizophreniform Disorder, Schizophrenia / Schizoaffective Disorder, Other Psychotic Disorder Not Due to A Substance or Known Physiological Condition
Enrollment 252 participants
Start Date 2026-05-27
Primary Completion 2028-09-01 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-15