Brief 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).

Conditions

• Delusional Disorder
• Brief Psychotic Disorder
• Schizophreniform Disorder
• Schizophrenia / Schizoaffective Disorder
• Other Psychotic Disorder Not Due to A Substance or Known Physiological Condition

Intervention / Treatment

• Behavioral: FEEL GOOD
• Other: Treatment as Usual (TAU)

Primary Outcome Measures

• Positive and Negative Symptom Scale Total Score (PANSS; Blinded assessment) (Baseline (t1), 4 weeks (t2); additional assessment at 6-months follow-up (t3))
  The primary outcome is observer-rated (blinded) total psychopathology as measured by the total score of PANSS after 4 weeks (t2). PANSS is widely used and the gold standard for psychopathological outcomes in people with psychotic disorders. It integrates positive, negative, and general psychopathological symptoms.

Countries

Germany

Locations and Investigators

• University of Mannheim, Central Institute of Mental Health, Department of Psychiatry and Psychotherapy, J5, 68169 Mannheim, Mannheim, Germany (Recruiting)
  • Lana Wölfl
  • Andreas Meyer-Lindenberg, Prof. Dr. (Principal Investigator)
  • Dusan Hirjak, Prof. Dr.
• University of Augsburg, Department of Psychiatry and Psychotherapy, Geschwister-Schoenert-Str. 1, 86156 Augsburg, Augsburg, Germany (Recruiting)
  • Benjamin Pross, Dr.
  • Alkomiet Hasan, Prof. Dr. (Principal Investigator)
• Ludwig-Maximilians Universität Munich, Department of Psychiatry and Psychotherapy, Nussbaumstr. 7, 80336 Munich, München, Germany (Recruiting)
  • Simone Sachenbacher, Dr.
  • Isabel Maurus, PD Dr.
  • Peter Falkai, Prof. Dr. (Principal Investigator)
  • Oliver Pogarell, Prof. Dr.
• University of Hamburg, Universitätsklinikum Hamburg-Eppendorf Hamburg, Department of Psychiatry and Psychotherapy, Hamburg, Germany (Recruiting)
  • Schirin Gellert
  • Jürgen Gallinat, Prof. Dr. (Principal Investigator)
  • Martin Lambert, Prof. Dr.
• Marburg University, Department of Psychiatry and Psychotherapy, Rudolf-Bultmann-Str. 8, 35039 Marburg, Germany, Marburg, Germany (Withdrawn)
• University of Cologne, Department of Psychiatry and Psychotherapy, Kerpener Str. 62, 50937 Cologne, Cologne, Germany (Recruiting)
  • Paula Mengelkamp
  • Joseph Kambeitz, Prof. Dr.
  • Frank Jessen, Prof. Dr. (Principal Investigator)
  • Joseph Kambeitz, Prof. Dr.
• Charité-Universitätsmedizin Berlin (CCM), Department of Psychiatry and Psychotherapy, , Charitéplatz 1, D-10117 Berlin, Germany, Berlin, Germany (Recruiting)
  • Kerem Böge, Prof. Dr. Dr
  • Malek Bajbouj, Prof. Dr. (Principal Investigator)
  • Kerem Böge, Prof. Dr. Dr.
• Vivantes Klinikum am Urban, Hospital for Psychiatry, Psychotherapy und Psychosomatics, Dieffenbachstr. 1, 10967 Berlin, Berlin, Germany (Recruiting)
  • Andreas Bechdolf, Prof. Dr.
  • Isabella Zimmermann
  • Andreas Bechdolf, Prof. Dr. (Principal Investigator)
  • Anja Lehmann, Dr.

Study Officials

• Andreas Bechdolf, Prof. Dr. (Principal Investigator) — Department of Psychiatry and Psychotherapy, CCM, Charité-Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin, Germany
• Stephanie Mehl, Prof. Dr. (Study Chair) — Marburg University, Department of Psychiatry and Psychotherapy, Rudolf-Bultmann-Strasse 8,35039 Marburg, Germany