Clinical Research Directory
Browse clinical research sites, groups, and studies.
FEEL-GOOD: A Multicenter Trial of a Mindfulness-Based Group Therapy in Young Adults With Early Psychosis
Sponsor: Stephanie Mehl
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).
Official title: Mindfulness-based Group Therapy in Young Inpatients With Acute Early Psychosis (FEEL-GOOD)
Key Details
Gender
All
Age Range
16 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
252
Start Date
2026-05-27
Completion Date
2028-12-31
Last Updated
2026-06-12
Healthy Volunteers
No
Conditions
Interventions
FEEL GOOD
FEEL-GOOD 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. The core of the intervention will be to provide insights into and to practice the essential elements of mindfulness and emotion regulation: attention to the present moment, as well as non-judgmental awareness and acceptance, and application of emotional awareness and emotion regulation skills. The following modules will be provided: (1) Information on emotions (2 sessions); (2) How to use mindfulness to better cope with distressing emotions and symptoms. (2 sessions); (3) How to reduce vulnerability towards negative emotions (1 session) and (4) Regulation of specific distressing emotions (anger, guild and shame: 2 sessions) and (5) a last session on crisis planning.
Treatment as Usual (TAU)
Standard inpatient psychiatric treatment for early psychosis including pharmacotherapy, supportive counselling, psychotherapeutic group interventions, occupational therapy, physiotherapy, and social work as clinically indicated.
Locations (8)
University of Mannheim, Central Institute of Mental Health, Department of Psychiatry and Psychotherapy, J5, 68169 Mannheim
Mannheim, Baden-Wurttemberg, Germany
University of Augsburg, Department of Psychiatry and Psychotherapy, Geschwister-Schoenert-Str. 1, 86156 Augsburg
Augsburg, Bavaria, Germany
Ludwig-Maximilians Universität Munich, Department of Psychiatry and Psychotherapy, Nussbaumstr. 7, 80336 Munich
München, Bavaria, Germany
University of Hamburg, Universitätsklinikum Hamburg-Eppendorf Hamburg, Department of Psychiatry and Psychotherapy
Hamburg, Free and Hanseatic City of Hamburg, Germany
Marburg University, Department of Psychiatry and Psychotherapy, Rudolf-Bultmann-Str. 8, 35039 Marburg, Germany
Marburg, Hesse, Germany
University of Cologne, Department of Psychiatry and Psychotherapy, Kerpener Str. 62, 50937 Cologne
Cologne, North Rhine-Westphalia, Germany
Charité-Universitätsmedizin Berlin (CCM), Department of Psychiatry and Psychotherapy, , Charitéplatz 1, D-10117 Berlin, Germany
Berlin, State of Berlin, Germany
Vivantes Klinikum am Urban, Hospital for Psychiatry, Psychotherapy und Psychosomatics, Dieffenbachstr. 1, 10967 Berlin
Berlin, State of Berlin, Germany