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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Psychosis; Psychosis NOS; First-episode Psychosis; Schizophrenia Spectrum Disorders (SSD); Randomized Controlled Trial (RCT); Early Onset Psychosis; First Psychotic Episode Within the Last 5 Years
• Intervention / Treatment: Behavioral: FEEL GOOD; Other: Treatment as Usual (TAU)

Detailed Description

After providing written informed consent, participants diagnoses will be confirmed with SCID-5-RV interview. The investigator will complete astandardized screening checklist to verify that all inclusion and exclusion criteria are (not) met prior to enrollment in the study. If patients they meet the required inclusion criteria and the exclusion criteria participants will complete baseline data assessment before randomization which will be performed adaptively fromwithin the data management system SecuTrial. Subjects will be randomized in a 1:1 allocation for each study site and will be balanced adaptively for gender and symptom severity as meas-ured by the PANSS total score (3 strata: mild with <54 points, moderate with 54-74 points, and high with >74 points). Participants will further complete two assessments at 4-week and6-month post-intervention. The final assessment for each participant (t3) constitutes the individual end of study participation. As participation is voluntary, participants may withdraw from the study prematurely at any time. Any withdrawal, and the reason for withdrawal will be documented. Reasons for withdrawal may include: 1) withdrawal of consent by participant defined as drop-out (without the need to provide justification), or 2) incorrect inclusion (e.g., subsequent determination of ineligibility).

The FEEL-GOOD trial aims to evaluate a mindfulness-based group therapy for young inpatients with acute early psychosis in addition to treatment as usual (TAU) in comparison to TAU at post-intervention (t2 after 4 weeks) regarding total psychopathology, positive and negative symptoms, and general psychopathology measured with the Positive and Negative Symp-tom Scale (PANSS), as well as acceptance of symptoms, mind- fulness-related and emotion regulation skills in inpatients with EP in comparison to the control group only receiving TAU. The rationale is that early psychosis is a critical treatment window, while current psychological interventions show limited efficacy and low adherence in younger patients; mindfulness-based interventions (MBI) may improve emotional awareness, acceptance, and emotion regulation.

Participants aged 16 to 35 years with early psychosis are recruited across eight German study sites (inpatient hospitals).

FEEL-GOOD is delivered by trained clinical psychologists or psychiatrists and consists of one individual preparatory session and eight modularized 50-minute group sessions over four weeks. Clinical psychologists or psychiatrists will conduct the intervention based on a detailed manual. It will follow the principals of MBI adapted for patients with psychosis. The patients will join the group therapy sessions (open-enrolling group) at any time and then participate at 8 consecutive sessions. Prior to the first group session, there will be an individual session with the study therapist, in which the participants will discuss and write down individual treatment goals related to mindfulness, emotional awareness and emotion regulation.

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. The intervention was developed in cooperation with Peer Coworkers.

An earlier version of the FEEL-GOOD group intervention was piloted in a feasibility study at Vivantes Hospital Berlin.

Primary Outcome: The primary outcome will be observer-rated (blinded) total psychopathology as measured by the total score of the Positive and Negative Syndrome Scale (PANSS) [post-treatment (4 weeks post baseline).

• Study Type: Interventional
• Enrollment (Estimated): 252
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mara Bach; Phone Number: +49 (0) 130 226095; Email: Mara.bach@charite.de
• Study Contact Backup: Name: Aisha J. L. Munk, PD Dr.; Phone Number: +49 (0) 130 226095; Email: Aisha.munk@charite.de

Study Locations

• Germany
  • Baden-Wurttemberg
    • Mannheim, Baden-Wurttemberg, Germany, 68159
      • Recruiting
      • University of Mannheim, Central Institute of Mental Health, Department of Psychiatry and Psychotherapy, J5, 68169 Mannheim
      • Contact: Lana Wölfl; Phone Number: 0049 (0) 621 1703 0; Email: Lana.Woelfl@zi-mannheim.de
      • Principal Investigator: Andreas Meyer-Lindenberg, Prof. Dr.
      • Sub-Investigator: Dusan Hirjak, Prof. Dr.
  • Bavaria
    • Augsburg, Bavaria, Germany, 86156
      • Recruiting
      • University of Augsburg, Department of Psychiatry and Psychotherapy, Geschwister-Schoenert-Str. 1, 86156 Augsburg
      • Contact: Benjamin Pross, Dr.; Phone Number: +49 (0) 821 4803 1600; Email: benjamin.pross@bkh-augsburg.de
      • Principal Investigator: Alkomiet Hasan, Prof. Dr.
    • München, Bavaria, Germany, 80336
      • Recruiting
      • Ludwig-Maximilians Universität Munich, Department of Psychiatry and Psychotherapy, Nussbaumstr. 7, 80336 Munich
      • Contact: Simone Sachenbacher, Dr.; Phone Number: +49 (0) 89 4400 52779; Email: Simone.Sachenbacher@med.uni-muenchen.de
      • Contact: Isabel Maurus, PD Dr.; Phone Number: +49 (0) 89 4400 53596; Email: isabel.maurus@med.uni-muenchen.de
      • Principal Investigator: Peter Falkai, Prof. Dr.
      • Sub-Investigator: Oliver Pogarell, Prof. Dr.
  • Free and Hanseatic City of Hamburg
    • Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246
      • Recruiting
      • University of Hamburg, Universitätsklinikum Hamburg-Eppendorf Hamburg, Department of Psychiatry and Psychotherapy
      • Principal Investigator: Jürgen Gallinat, Prof. Dr.
      • Contact: Schirin Gellert; Phone Number: +49 (0) 40 7410 53210; Email: S.Gellert@uke.de
      • Sub-Investigator: Martin Lambert, Prof. Dr.
  • Hesse
    • Marburg, Hesse, Germany, 35039
      • Recruiting
      • Marburg University, Department of Psychiatry and Psychotherapy, Rudolf-Bultmann-Str. 8, 35039 Marburg, Germany
      • Contact: Igor Nenadiç, Prof. Dr; Phone Number: +49 (0) 6421 58 65002; Email: nenadic@uni-marburg.de
      • Contact: Stephanie Mehl, Prof. Dr.; Phone Number: +49 (0)6421 58 65200; Email: stephanie.mehl@uni-marburg.de
      • Principal Investigator: Igor Nenadiç, Prof. Dr.
      • Sub-Investigator: Stephanie Mehl, Prof. Dr.
  • North Rhine-Westphalia
    • Cologne, North Rhine-Westphalia, Germany, 50937
      • Recruiting
      • University of Cologne, Department of Psychiatry and Psychotherapy, Kerpener Str. 62, 50937 Cologne
      • Contact: Paula Mengelkamp; Phone Number: +49 (0) 221 478 87291; Email: paula.mengelkamp1@uk-koeln.de
      • Contact: Joseph Kambeitz, Prof. Dr.; Phone Number: +49 (0) 221 478 87291; Email: joseph.kambeitz@uk-koeln.de
      • Principal Investigator: Frank Jessen, Prof. Dr.
      • Sub-Investigator: Joseph Kambeitz, Prof. Dr.
  • State of Berlin
    • Berlin, State of Berlin, Germany, 10117
      • Recruiting
      • Charité-Universitätsmedizin Berlin (CCM), Department of Psychiatry and Psychotherapy, , Charitéplatz 1, D-10117 Berlin, Germany
      • Contact: Kerem Böge, Prof. Dr. Dr; Phone Number: +49 (0) 30 450 517 319; Email: kerem.boege@charite.de
      • Principal Investigator: Malek Bajbouj, Prof. Dr.
      • Sub-Investigator: Kerem Böge, Prof. Dr. Dr.
    • Berlin, State of Berlin, Germany, 10967
      • Recruiting
      • Vivantes Klinikum am Urban, Hospital for Psychiatry, Psychotherapy und Psychosomatics, Dieffenbachstr. 1, 10967 Berlin
      • Contact: Andreas Bechdolf, Prof. Dr.; Phone Number: +49 (0) 30 130 22 60 01; Email: andreas.bechdolf@vivantes.de
      • Contact: Aisha J.L. Munk, PD Dr.; Phone Number: +49 (0) 30 130 226095; Email: aisha.munk@vivantes.de
      • Principal Investigator: Andreas Bechdolf, Prof. Dr.
      • Sub-Investigator: Anja Lehmann, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive and negative symptoms, general psychopathology as measured by PANSS Positive, Negative and General Psychopathology subscales (Blinded assessment)	The PANSS is a semi-structured interview to assess positive symptoms (PANSS Positive Scale), negative symptoms (PANSS Negative Scale) and general pathology (PANSS General Psychopathology Scale) of Psychosis.	Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Five-Facet Mindfulness Questionnaire (FFFM-D) (Self Report, putative mediator)	The FFMQ-D consists of 39 items forming the 5 subscales non-reactivity to inner experience, observing, acting with awareness, describing/labelling with words, and nonjudging of inner experience. Items are self-rated on a 5-point Likert-scale.	Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Rosenberg Self-Esteem Scale total score (RSES) (Self Report, putative mediator)	Global self-esteem will be assessed with the RSES that consists of 10 items self-rated on a 4-point Likert-scale.	Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Ecological Momentary Assessment (EMA) (Self Report, putative mediator)	Participants will complete EMA via the m-Path mobile application starting after giving informed consent and randomisation into the trial and will end seven days post-intervention. There will be one prompt per day. Each prompt will include approximately 39-46 items, depending on conditional branching. The questions will cover several domains, such as current emotional state, psychopathological symptoms, mindfulness, emotional (in-)stability, and emotion regulation skills.	Once a day during intervention period from baseline through the post-intervention phase
Toronto Alexithymia Scale (TAS-26) (Self Report, putative mediator)	The TAS-26 is the German version of the TASand consists of 26 items with the 3 subscales: Difficulties Identifying Feelings, Difficulties Describing Feelings, and Externally Oriented Thinking self-rated on a 5-point Likert-scale.	Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Cognitive Emotion Regulation Questionnaire (CERQ) (Self Report, putative mediator)	The CERQ measures cognitive coping strategies, i.e., thoughts after negative events or situations on 9 subscales (self-blame, blaming others, acceptance, refocusing on planning, positive refocusing, rumination, positive reappraisal, putting into perspective, and catastrophizing), each consisting of 4 items that are self-rated on 5-point Likert-scales.	Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Emotion regulation skills (ERSQ) (Self Report, putative mediator)	The ERSQ consists of 27 items with 9 subscales assessing competencies that are considered essential for successful emotion regulation (i.e., attention, clarity, bodily awareness, understanding, acceptance, resilience, self-support, willingness to confront, and regulation). Self-reports are rated on a 5-point Likert-scale.	Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Patient satisfaction questionnaire (ZUF) (Self Report, putative mediator)	The ZUF-8 is the German version adapted for inpatients based on the Client Satisfaction Questionnaire (CSQ-8). It consists of 8 items self-rated on a 4-point Likert-scale and assesses patients' overall satisfaction with the clinical treatment received.	4 weeks (t2), 6 months follow-up (t3)
World Health Organization Quality of Life - 100 item version (WHOQOL-BREF) (Self Report, putative mediator)	The WHOQOL-BREF assesses quality of life as a subjective evaluation, embedded within the individual's cultural, social, and environmental context using 26 items divided into 4 domains: physical health, psychological well-being, social relationships, and environment. Items are rated on a 5-point Likert-scale.	Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Psychotic Symptom Rating Scales to assess delusions (PSYRATS-D) and hallucinations (PSYRATS-H) (Blinded assessment)	The PSYRATS is a semi-structured interview to assess delusions and hallucinations. It consist of 17 items assessing specific dimensions of hallucinations and delusions. Each item is observer-rated on a 5-point scale ranging from 0 (= absent) to 4 (=severe). The PSYRATS include two subscales: hallucinations with 11 items (PSYRATS-H) and delusions with 6 items (PSYRATS-D).	Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Depressive symptoms using the Calgary Depression Scale for Schizophrenia (CDSS) (Blinded asessment)	The CDSS is considered as the gold standard to assess depression specifically in people with schizophrenia spectrum disorders. The 9 items are observer-rated on a scale ranging from 0 (=absent) to 3 (=severe). It distinguishes between depressive symptoms, positive, negative, and extrapyramidal symptoms in adolescents and adults	Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Role Functioning Scale (RFS) (Blinded assessment)	The RFS is a semi-structured interview that measures performance on 4 single rating scales: working productivity, independent living, immediate social network relationships (friends and family), and extended social network relationships (other social contacts) with observer ratings from 0 (= minimal functioning) to 12 (= optimal functioning).	Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Global Assessment of Functioning (GAF), (Blinded assessment)	In the GAF scale, clinicians rate a patient's overall level of psychological, social, and occupational functioning using a single score ranging from 1 to 100. A score of 100 represents superior functioning, whereas a score of 1 indicates a persistent risk of serious harm to oneself or others, severe impairment in basic self-care, or a suicidal act with clear expectation of death. Changes of approximately 4, 10, or 12 points have been suggested to represent clinically meaningful differences [15].	Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Serious adverse events (SAEs) (Blinded Assessment)	Serious adverse events are assessed and consist of suicidality, suicide attempts, death, life-threatening events or hospitalization (if patients were previously in outpatient treatment).	Continuously during intervention and follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Childhood Trauma Questionnaire (CTQ) (Self Report)	The self-rating questionnaire Child Trauma Questionnaire (CTQ) consists of five subscales: emotional abuse, physical abuse, sexual abuse, emotional neglect, and physical neglect, each comprising five items, and an additional minimization/denial scale consisting of 3 items. Items are rated on a 5-point Likert-Scale.	Baseline (t1)
Cognitive Therapy Scale Revised for Psychosis (CTS-R-P)	The Cognitive Therapy Scale Revised for Psychosis (CTS-R-P) is used as an adapted version to assess video or audio recordings of the group intervention and the preparatory session to evaluate adherence to cognitive therapy principles and the overall competence of therapists delivering the intervention. A random selection of 25% of all recordings are assessed.	During the intervention period (4 weeks)
Mindfulness-Based Cognitive Therapy Adherence Scale (MBCT-AS)	Recordings of the group sessions are rated using the MBCT-AS in order to to assess how closely therapists adhere to the core principles and procedures of Mindfulness-Based Cognitive Therapy. A random selection of 25% of all recordings are assessed.	During the intervention period (4 weeks).
Structured Clinical Interview for DSM-5 (Research Version)	Diagnoses are confirmed using the structured interview SCID-5-RV. The SCID is an interview designed to systematically assess DSM-5 mental disorders for research purposes.	Baseline (t1)
Multiple Choice Vocabulary Intellicence Test (MVT-B)	The MVT-B is a brief multiple choice vocabulary test that is used to estimate verbal intelligence.	Baseline (t1)
Assessment of Sociodemographic and Clinical Variables	Socio-demographic data will be collected by raters at baseline to describe the study population. Core variables include age, gender, education, migration background, residential status and employment status. Clinical variables include the number of previous hospitalisations and outpatient treatments, medication and duration of illness. Medication, hospitalisations and additional treatments will be assessed additionally post-intervention and at 6-months follow-up.	Baseline (t1), 4-months post-intervention (t2) and 6-months follow-up (t3)
Assessment of withdrawal and reasons for withdrawal	Any withdrawal, and the reason for withdrawal will be documented. Reasons for withdrawal may include: 1) withdrawal of consent by participant defined as drop-out (without the need to provide justification), or 2) incorrect inclusion (e.g., subsequent determination of ineligibility).	During the intervention and at 6-months follow-up (T3)

Collaborators and Investigators

• Sponsor: Stephanie Mehl
• Collaborators: German Research Foundation; Charite University, Berlin, Germany; Ludwig-Maximilians - University of Munich; Universitätsklinikum Hamburg-Eppendorf; University Hospital of Cologne; Central Institute of Mental Health, Mannheim; University Hospital Augsburg; Vivantes Klinikum am Urban; Philipps University Marburg
• Investigators: Principal Investigator: Andreas Bechdolf, Prof. Dr., Department of Psychiatry and Psychotherapy, CCM, Charité-Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin, Germany; Study Chair: Stephanie Mehl, Prof. Dr., Marburg University, Department of Psychiatry and Psychotherapy, Rudolf-Bultmann-Strasse 8,35039 Marburg, Germany

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 16, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Psychosis; Randomized controlled trial; Mindfulness; Early psychosis; Emotion regulation; PANSS; Ecological momentary assessment; EMA; Schizophrenia spectrum disorder; Mindfulness-based intervention; First-episode psychosis; observer-rated
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Behavior; Social Behavior; Self-Control; Psychotic Disorders; Mental Disorders; Emotional Regulation; Therapeutics
• Other Study ID Numbers: BE 3967/5-1 (Other Identifier: German Research Foundation (DFG)); EA2/287/25 (Other Identifier: Ethics Commission Charité Berlin)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Patients will not be asked whether they consent to individual data sharing. It might be possible to share some individual anonymized data based on agreement of the Data Protection Official of each individual study site.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No