Delusional DisorderFEEL-GOODNCT07645443
FEEL-GOOD: A Multicenter Trial of a Mindfulness-Based Group Therapy in Young Adults With Early Psychosis
A study testing FEEL GOOD and Treatment as Usual (TAU) in people with Delusional Disorder and Brief Psychotic Disorder, run by Stephanie Mehl at 8 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Delusional Disorder, Brief Psychotic Disorder, Schizophreniform Disorder
- What is being tested?
- FEEL GOOD and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 8 sitesGermany
- Study dates
- 27 May 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Insufficient German language abilities
- Acute suicidality or acute threat to others
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Germany8 sites, 7 recruiting
- Recruiting
University of Augsburg, Department of Psychiatry and Psychotherapy, Geschwister-Schoenert-Str. 1, 86156 Augsburg
Augsburg, Bavaria, 86156
Benjamin Pross, Dr., +49 (0) 821 4803 1600, benjamin.pross@bkh-augsburg.de
Alkomiet Hasan, Prof. Dr.
- Recruiting
Charité-Universitätsmedizin Berlin (CCM), Department of Psychiatry and Psychotherapy, , Charitéplatz 1, D-10117 Berlin, Germany
Berlin, State of Berlin, 10117
Kerem Böge, Prof. Dr. Dr, +49 (0) 30 450 517 319, kerem.boege@charite.de
Malek Bajbouj, Prof. Dr.
- Recruiting
Vivantes Klinikum am Urban, Hospital for Psychiatry, Psychotherapy und Psychosomatics, Dieffenbachstr. 1, 10967 Berlin
Berlin, State of Berlin, 10967
Andreas Bechdolf, Prof. Dr., +49 (0) 30 130 22 60 01, andreas.bechdolf@vivantes.de
Isabella Zimmermann, +49 (0) 30 450 676 368, isabella.zimmermann@vivantes.de
- Recruiting
University of Cologne, Department of Psychiatry and Psychotherapy, Kerpener Str. 62, 50937 Cologne
Cologne, North Rhine-Westphalia, 50937
Paula Mengelkamp, +49 (0) 221 478 87291, paula.mengelkamp1@uk-koeln.de
Joseph Kambeitz, Prof. Dr., +49 (0) 221 478 87291, joseph.kambeitz@uk-koeln.de
- Recruiting
University of Hamburg, Universitätsklinikum Hamburg-Eppendorf Hamburg, Department of Psychiatry and Psychotherapy
Hamburg, Free and Hanseatic City of Hamburg, 20246
Schirin Gellert, +49 (0) 40 7410 53210, S.Gellert@uke.de
Jürgen Gallinat, Prof. Dr.
- Recruiting
University of Mannheim, Central Institute of Mental Health, Department of Psychiatry and Psychotherapy, J5, 68169 Mannheim
Mannheim, Baden-Wurttemberg, 68159
Lana Wölfl, 0049 (0) 621 1703 0, Lana.Woelfl@zi-mannheim.de
Andreas Meyer-Lindenberg, Prof. Dr.
- Withdrawn
Marburg University, Department of Psychiatry and Psychotherapy, Rudolf-Bultmann-Str. 8, 35039 Marburg, Germany
Marburg, Hesse, 35039
- Recruiting
Ludwig-Maximilians Universität Munich, Department of Psychiatry and Psychotherapy, Nussbaumstr. 7, 80336 Munich
München, Bavaria, 80336
Simone Sachenbacher, Dr., +49 (0) 89 4400 52779, Simone.Sachenbacher@med.uni-muenchen.de
Isabel Maurus, PD Dr., +49 (0) 89 4400 53596, isabel.maurus@med.uni-muenchen.de
About this study
Official title: 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).
Read the 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).
- Conditions
- Delusional Disorder, Brief Psychotic Disorder, Schizophreniform Disorder, Schizophrenia / Schizoaffective Disorder, Other Psychotic Disorder Not Due to A Substance or Known Physiological Condition
- Being tested
- FEEL GOOD, Treatment as Usual (TAU)
- Keywords
- Randomized controlled trial, Emotion regulation, Ecological momentary assessment, Early psychosis, First-episode psychosis, EMA, Schizophrenia spectrum disorder, Psychosis, Mindfulness, Mindfulness-based Interventions, Schizophrenia, Schizoaffective disorder, Delusional disorder
- Medical subject headings
- Schizophrenia, Paranoid, Psychotic Disorders, Schizophrenia, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEEL GOODBehavioural
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.
Standard inpatient psychiatric treatment for early psychosis including pharmacotherapy, supportive counselling, psychotherapeutic group interventions, occupational therapy, physiotherapy, and social work as clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Starting at t1, EMA is assessed once a day during the intervention period including 7 days post t2-assessment at four weeks.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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).
Measured: 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].
Measured: 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).
Measured: Continuously during intervention and follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start27 May 2026
- Primary completion1 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delusional DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group single-blinded randomized controlled trial comparing FEEL-GOOD + treatment as usual (TAU) with TAU alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stephanie Mehl
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation, Central Institute of Mental Health, Mannheim, Ludwig-Maximilians - University of Munich, Charite University, Berlin, Germany, Vivantes Klinikum am Urban, Philipps University Marburg, University of Cologne, Universitätsklinikum Hamburg-Eppendorf, University Hospital Augsburg
- Responsible party
- Sponsor-investigator, Stephanie Mehl, Berlin Institute of Health @ Charité
- Investigators
- Andreas Bechdolf, Prof. Dr., Principal investigator, Department of Psychiatry and Psychotherapy, CCM, Charité-Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin, GermanyStephanie Mehl, Prof. Dr., Study chair, Marburg University, Department of Psychiatry and Psychotherapy, Rudolf-Bultmann-Strasse 8,35039 Marburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645443
- Sponsor's protocol ID
- BE 3967/5-1
- Other IDs
- EA2/287/25, BE 3967/5-1
- Acronym
- FEEL-GOOD
- Status last verified
- Sep 2026
- First submitted
- 16 May 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Group Therapy in Young Inpatients With Acute Early Psychosis (FEEL-GOOD)
- ClinicalTrials.gov ID
- NCT07645443
- Acronym / sponsor ID
- FEEL-GOOD / BE 3967/5-1
- Conditions
- Delusional Disorder, Brief Psychotic Disorder, Schizophreniform Disorder, Schizophrenia / Schizoaffective Disorder, Other Psychotic Disorder Not Due to A Substance or Known Physiological Condition
- Keywords
- Randomized controlled trial, Emotion regulation, Ecological momentary assessment, Early psychosis, First-episode psychosis, EMA, Schizophrenia spectrum disorder, Psychosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Stephanie MehlUniversity, hospital or other
- Collaborators
- German Research Foundation, Central Institute of Mental Health, Mannheim, Ludwig-Maximilians - University of Munich, Charite University, Berlin, Germany, Vivantes Klinikum am Urban, Philipps University Marburg, University of Cologne, Universitätsklinikum Hamburg-Eppendorf, University Hospital Augsburg
- Study start
- 27 May 2026 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-group single-blinded randomized controlled trial comparing FEEL-GOOD + treatment as usual (TAU) with TAU alone.
| Arm | Type | Receives |
|---|---|---|
| FEEL-GOOD + TAU | Experimental | Behavioral: FEEL GOODFEEL-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. |
| TAU | Active comparator | Other: Treatment as Usual (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. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Insufficient German language abilities
- Acute suicidality or acute threat to others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FEEL GOODFEEL-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. | Behavioural | FEEL-GOOD + TAU |
| 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. | Other | TAU |
Primary outcome
Positive and Negative Symptom Scale Total Score (PANSS; Blinded assessment)
Time frame: 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.
14 secondary outcomes
Positive and negative symptoms, general psychopathology as measured by PANSS Positive, Negative and General Psychopathology subscales (Blinded assessment)
Time frame: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Five-Facet Mindfulness Questionnaire (FFFM-D) (Self Report, putative mediator)
Time frame: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Rosenberg Self-Esteem Scale total score (RSES) (Self Report, putative mediator)
Time frame: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Ecological Momentary Assessment (EMA) (Self Report, putative mediator)
Time frame: Starting at t1, EMA is assessed once a day during the intervention period including 7 days post t2-assessment at four weeks.
Toronto Alexithymia Scale (TAS-26) (Self Report, putative mediator)
Time frame: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Cognitive Emotion Regulation Questionnaire (CERQ) (Self Report, putative mediator)
Time frame: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Emotion regulation skills (ERSQ) (Self Report, putative mediator)
Time frame: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Patient satisfaction questionnaire (ZUF) (Self Report, putative mediator)
Time frame: 4 weeks (t2), 6 months follow-up (t3)
World Health Organization Quality of Life - 100 item version (WHOQOL-BREF) (Self Report, putative mediator)
Time frame: 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)
Time frame: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Depressive symptoms using the Calgary Depression Scale for Schizophrenia (CDSS) (Blinded asessment)
Time frame: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Role Functioning Scale (RFS) (Blinded assessment)
Time frame: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Global Assessment of Functioning (GAF), (Blinded assessment)
Time frame: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Serious adverse events (SAEs) (Blinded Assessment)
Time frame: Continuously during intervention and follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FEEL GOOD and Treatment as Usual (TAU) in people with Delusional Disorder and Brief Psychotic Disorder, run by Stephanie Mehl at 8 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mara Bach (+49 (0) 130 226095, Mara.bach@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Symptom Scale Total Score (PANSS; Blinded assessment) (time frame: Baseline (t1), 4 weeks (t2); additional assessment at 6-months follow-up (t3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.