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

Description

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).

Interventions

• FEEL GOOD (Behavioral)
  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) (Other)
  Standard inpatient psychiatric treatment for early psychosis including pharmacotherapy, supportive counselling, psychotherapeutic group interventions, occupational therapy, physiotherapy, and social work as clinically indicated.

Eligibility criteria

Conditions

Locations

• 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