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).
Age 16 to 35 years
Clinical diagnosis of early psychosis, defined as first psychotic episode within the last 5 years as assessed with the Structural Clinical Interview for DSM-5 Research Version (SCID-5-RV)
DSM-5 schizophrenia spectrum or other psychotic disorder confirmed with SCID-5-RV (DSM-5: 297.1, 298.8, 295.4, 295.9, 295.7, 298.8, 298.9) Currently receiving inpatient/day clinic treatment with a planned stay of at least 4 weeks
Interested in and willing to participate in FEEL-GOOD and/or TAU.
Insufficient German language abilities
Acute suicidality or acute threat to others
Stephanie Mehl
Lead sponsor
Berlin Institute of Health @ Charité
Sponsor institution
German Research Foundation
Collaborator
Universitätsklinikum Hamburg-Eppendorf
Collaborator
Central Institute of Mental Health, Mannheim
Collaborator
University Hospital Augsburg
Collaborator
Ludwig-Maximilians - University of Munich
Collaborator
Charite University, Berlin, Germany
Collaborator
University Hospital of Cologne
Collaborator
Vivantes Klinikum am Urban
Collaborator
Philipps University Marburg
Collaborator