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

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).

• 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.
• 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.

Primary outcomes

• 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.

Secondary outcomes

• 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)]: 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.
• Five-Facet Mindfulness Questionnaire (FFFM-D) (Self Report, putative mediator) [Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)]: 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.
• Rosenberg Self-Esteem Scale total score (RSES) (Self Report, putative mediator) [Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)]: Global self-esteem will be assessed with the RSES that consists of 10 items self-rated on a 4-point Likert-scale.
• Ecological Momentary Assessment (EMA) (Self Report, putative mediator) [Starting at t1, EMA is assessed once a day during the intervention period including 7 days post t2-assessment at four weeks.]: 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.
• Toronto Alexithymia Scale (TAS-26) (Self Report, putative mediator) [Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)]: 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.
• Cognitive Emotion Regulation Questionnaire (CERQ) (Self Report, putative mediator) [Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)]: 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.
• Emotion regulation skills (ERSQ) (Self Report, putative mediator) [Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)]: 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.
• Patient satisfaction questionnaire (ZUF) (Self Report, putative mediator) [4 weeks (t2), 6 months follow-up (t3)]: 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.
• World Health Organization Quality of Life - 100 item version (WHOQOL-BREF) (Self Report, putative mediator) [Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)]: 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.
• Psychotic Symptom Rating Scales to assess delusions (PSYRATS-D) and hallucinations (PSYRATS-H) (Blinded assessment) [Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)]: 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).
• Depressive symptoms using the Calgary Depression Scale for Schizophrenia (CDSS) (Blinded asessment) [Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)]: 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
• Role Functioning Scale (RFS) (Blinded assessment) [Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)]: 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).
• Global Assessment of Functioning (GAF), (Blinded assessment) [Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)]: 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 \[15\].
• Serious adverse events (SAEs) (Blinded Assessment) [Continuously during intervention and follow-up]: Serious adverse events are assessed and consist of suicidality, suicide attempts, death, life-threatening events or hospitalization (if patients were previously in outpatient treatment).

Other outcomes

• Childhood Trauma Questionnaire (CTQ) (Self Report) [Baseline (t1)]: 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.
• Cognitive Therapy Scale Revised for Psychosis (CTS-R-P) [During the intervention period (4 weeks)]: 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.
• Mindfulness-Based Cognitive Therapy Adherence Scale (MBCT-AS) [During the intervention period (4 weeks).]: 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.
• Structured Clinical Interview for DSM-5 (Research Version) [Baseline (t1)]: 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.
• Assessment of Sociodemographic and Clinical Variables [Baseline (t1), 4 weeks (t2) and 6-months follow-up (t3)]: 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.
• Assessment of withdrawal and reasons for withdrawal [During the intervention and at 6-months follow-up (T3)]: 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).

Sex: All, ages: 16 Years to 35 Years

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 Protocol (PDF, 2026-08-25)

• 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