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

NCT07645443 | Recruiting DMC

• 2 other identifiers: BE 3967/5-1EA2/287/25
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 8

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

Early Onset Psychosis; First Psychotic Episode Within the Last 5 Years; First-episode Psychosis; Schizophrenia Spectrum Disorders (SSD); Psychosis; Psychosis NOS; Randomized Controlled Trial (RCT)

Keywords

Randomized controlled trial; Emotion regulation; Ecological momentary assessment; Early psychosis; First-episode psychosis; Mindfulness-based intervention; PANSS; EMA; Schizophrenia spectrum disorder; Psychosis; Mindfulness; observer-rated

Outcome Measures

Primary Outcomes (1)

• Positive and Negative Symptom Scale Total Score (PANSS; Blinded assessment)

  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.

  Baseline (t1), 4 weeks (t2); additional assessment at 6-months follow-up (t3)

Secondary Outcomes (14)

• Positive and negative symptoms, general psychopathology as measured by PANSS Positive, Negative and General Psychopathology subscales (Blinded assessment)

  Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)

• Five-Facet Mindfulness Questionnaire (FFFM-D) (Self Report, putative mediator)

  Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)

• Rosenberg Self-Esteem Scale total score (RSES) (Self Report, putative mediator)

  Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)

• Ecological Momentary Assessment (EMA) (Self Report, putative mediator)

  Once a day during intervention period from baseline through the post-intervention phase

• Toronto Alexithymia Scale (TAS-26) (Self Report, putative mediator)

  Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)

Other Outcomes (7)

• Childhood Trauma Questionnaire (CTQ) (Self Report)

  Baseline (t1)

• Cognitive Therapy Scale Revised for Psychosis (CTS-R-P)

  During the intervention period (4 weeks)

• Mindfulness-Based Cognitive Therapy Adherence Scale (MBCT-AS)

  During the intervention period (4 weeks).

Study Arms (2)

FEEL-GOOD + TAU

EXPERIMENTAL

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.

Behavioral: FEEL GOOD

TAU

ACTIVE COMPARATOR

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.

Other: Treatment as Usual (TAU)

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.

FEEL-GOOD + TAU

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.

TAU

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Insufficient German language abilities
• Acute suicidality or acute threat to others

Sponsors & Collaborators

• Stephanie Mehl: lead
• German Research Foundation: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• Central Institute of Mental Health, Mannheim: collaborator
• University Hospital Augsburg: collaborator
• Ludwig-Maximilians - University of Munich: collaborator
• Charite University, Berlin, Germany: collaborator
• University Hospital of Cologne: collaborator
• Vivantes Klinikum am Urban: collaborator
• Philipps University Marburg: collaborator

Study Sites (8)

University of Mannheim, Central Institute of Mental Health, Department of Psychiatry and Psychotherapy, J5, 68169 Mannheim

Mannheim, Baden-Wurttemberg, 68159, Germany

RECRUITING

University of Augsburg, Department of Psychiatry and Psychotherapy, Geschwister-Schoenert-Str. 1, 86156 Augsburg

Augsburg, Bavaria, 86156, Germany

RECRUITING

Ludwig-Maximilians Universität Munich, Department of Psychiatry and Psychotherapy, Nussbaumstr. 7, 80336 Munich

München, Bavaria, 80336, Germany

RECRUITING

University of Hamburg, Universitätsklinikum Hamburg-Eppendorf Hamburg, Department of Psychiatry and Psychotherapy

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

RECRUITING

Marburg University, Department of Psychiatry and Psychotherapy, Rudolf-Bultmann-Str. 8, 35039 Marburg, Germany

Marburg, Hesse, 35039, Germany

RECRUITING

University of Cologne, Department of Psychiatry and Psychotherapy, Kerpener Str. 62, 50937 Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Charité-Universitätsmedizin Berlin (CCM), Department of Psychiatry and Psychotherapy, , Charitéplatz 1, D-10117 Berlin, Germany

Berlin, State of Berlin, 10117, Germany

RECRUITING

Vivantes Klinikum am Urban, Hospital for Psychiatry, Psychotherapy und Psychosomatics, Dieffenbachstr. 1, 10967 Berlin

Berlin, State of Berlin, 10967, Germany

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Mental Disorders; Emotional Regulation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Andreas Bechdolf, Prof. Dr.

  Department of Psychiatry and Psychotherapy, CCM, Charité-Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Stephanie Mehl, Prof. Dr.

  Marburg University, Department of Psychiatry and Psychotherapy, Rudolf-Bultmann-Strasse 8,35039 Marburg, Germany

  STUDY CHAIR

Central Study Contacts

Mara Bach

CONTACT

+49 (0) 130 226095; Mara.bach@charite.de

Aisha J. L. Munk, PD Dr.

CONTACT

+49 (0) 130 226095; Aisha.munk@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a prospective randomized open blinded endpoint (PROBE) trial. Participants and care providers are aware of treatment allocation because of the nature of the intervention. Independent outcome assessors conducting clinician-rated measures are blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Principal Investigator

Model Details: Parallel-group single-blinded randomized controlled trial comparing FEEL-GOOD + treatment as usual (TAU) with TAU alone.

Study Record Dates

• First Submitted: May 16, 2026
• First Posted: June 12, 2026
• Study Start: May 27, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

DE (8)