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Mindfulness-based Group Therapy in Young Inpatients With Acute Early Psychosis (FEEL-GOOD)

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 35
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Germany
University of Augsburg, Department of Psychiatry and Psychotherapy, Geschwister-Schoenert-Str. 1, 86156 Augsburg
RECRUITING
Augsburg
Charité-Universitätsmedizin Berlin (CCM), Department of Psychiatry and Psychotherapy, , Charitéplatz 1, D-10117 Berlin, Germany
RECRUITING
Berlin
Vivantes Klinikum am Urban, Hospital for Psychiatry, Psychotherapy und Psychosomatics, Dieffenbachstr. 1, 10967 Berlin
RECRUITING
Berlin
University of Cologne, Department of Psychiatry and Psychotherapy, Kerpener Str. 62, 50937 Cologne
RECRUITING
Cologne
University of Hamburg, Universitätsklinikum Hamburg-Eppendorf Hamburg, Department of Psychiatry and Psychotherapy
RECRUITING
Hamburg
University of Mannheim, Central Institute of Mental Health, Department of Psychiatry and Psychotherapy, J5, 68169 Mannheim
RECRUITING
Mannheim
Marburg University, Department of Psychiatry and Psychotherapy, Rudolf-Bultmann-Str. 8, 35039 Marburg, Germany
RECRUITING
Marburg
Ludwig-Maximilians Universität Munich, Department of Psychiatry and Psychotherapy, Nussbaumstr. 7, 80336 Munich
RECRUITING
München
Contact Information
Primary
Mara Bach
Mara.bach@charite.de
+49 (0) 130 226095
Backup
Aisha J. L. Munk, PD Dr.
Aisha.munk@charite.de
+49 (0) 130 226095
Time Frame
Start Date: 2026-05-27
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 252
Treatments
Experimental: FEEL-GOOD + TAU
FEEL-GOOD + TAU. 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. Patients additionally receive Treatment as Usual (TAU) as described below.
Active_comparator: TAU
Participants receive treatment as usual (TAU), consisting of standard inpatient psychiatric care for early psychosis, including pharmacotherapy, supportive counselling, psychotherapeutic group interventions, occupational therapy, physiotherapy, and social work as clinically indicated.
Related Therapeutic Areas
Sponsors
Collaborators: Philipps University Marburg, Ludwig-Maximilians - University of Munich, Universitätsklinikum Hamburg-Eppendorf, Charite University, Berlin, Germany, Vivantes Klinikum am Urban, German Research Foundation, University Hospital of Cologne, Central Institute of Mental Health, Mannheim, University Hospital Augsburg
Leads: Stephanie Mehl

This content was sourced from clinicaltrials.gov