FEEL-GOOD: Mindfulness group therapy for young adults with early psychosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

FEEL-GOOD is a multicenter, single-blinded randomized trial enrolling 16- to 35-year-olds with acute early psychosis. Participants are randomized 1:1 to receive an eight-session mindfulness-based group therapy over four weeks in addition to treatment as usual (TAU) or TAU alone. The intervention includes one preparatory session and modular group sessions with 4–8 participants per group, plus home practice. Assessments occur at baseline, at 4 weeks post-intervention, and at 6 months, with the primary outcome being total psychopathology measured by the PANSS total score after the four-week treatment period. Diagnoses are confirmed with SCID-5-RV, and adaptive randomization balances for gender and baseline symptom severity are used across sites.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Insufficient German language abilities
* Acute suicidality or acute threat to others

Where it's running

• University of Mannheim, Central Institute of Mental Health, Department of Psychiatry and Psychotherapy, J5, 68169 Mannheim
  Mannheim, Baden-Wurttemberg, Germany Recruiting
• University of Augsburg, Department of Psychiatry and Psychotherapy, Geschwister-Schoenert-Str. 1, 86156 Augsburg
  Augsburg, Bavaria, Germany Recruiting
• Ludwig-Maximilians Universität Munich, Department of Psychiatry and Psychotherapy, Nussbaumstr. 7, 80336 Munich
  München, Bavaria, Germany Recruiting
• University of Hamburg, Universitätsklinikum Hamburg-Eppendorf Hamburg, Department of Psychiatry and Psychotherapy
  Hamburg, Free and Hanseatic City of Hamburg, Germany Recruiting
• University of Cologne, Department of Psychiatry and Psychotherapy, Kerpener Str. 62, 50937 Cologne
  Cologne, North Rhine-Westphalia, Germany Recruiting
• Charité-Universitätsmedizin Berlin (CCM), Department of Psychiatry and Psychotherapy, , Charitéplatz 1, D-10117 Berlin, Germany
  Berlin, State of Berlin, Germany Recruiting

Study contacts

• Principal investigator: Andreas Bechdolf, Prof. Dr. — Department of Psychiatry and Psychotherapy, CCM, Charité-Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin, Germany
• Study coordinator: Mara Bach
• Email: Mara.bach@charite.de
• Phone: +49 (0) 130 226095

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.