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

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

Interventions

BEHAVIORAL

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.

OTHER

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.

Sponsors & Collaborators

• German Research Foundation

  collaborator OTHER

• Central Institute of Mental Health, Mannheim

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• Vivantes Klinikum am Urban

  collaborator OTHER

• Philipps University Marburg

  collaborator OTHER

• University of Cologne

  collaborator OTHER

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• University Hospital Augsburg

  collaborator OTHER

• Stephanie Mehl

  lead OTHER

Principal Investigators

• Andreas Bechdolf, Prof. Dr. · Department of Psychiatry and Psychotherapy, CCM, Charité-Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin, Germany

• Stephanie Mehl, Prof. Dr. · Marburg University, Department of Psychiatry and Psychotherapy, Rudolf-Bultmann-Strasse 8,35039 Marburg, Germany

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-27

Primary Completion

2028-09-01

Completion

2028-12-31

Countries

• Germany

Study Locations