An interventional study of FEEL GOOD and Treatment as Usual (TAU) in Delusional Disorder, Brief Psychotic Disorder and Schizophreniform Disorder, sponsored by Stephanie Mehl. Recruiting at 8 sites in Germany. Open to participants aged 16 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Stephanie Mehl · Not applicable, Interventional, and Treatment
Among 72 studies in Psychotic Disorders with a site in Germany — 20 open to participants now, 22 under way, 4 of them phase 3. Psychotic Disorders · Germany.
Among the 72 studies in Psychotic Disorders with a site in Germany, this one is the 18th largest by planned enrollment of the 65 interventional ones that give a count, is one of 6 that started in 2026, is one of 33 with no phase, reaches primary completion later than 18 of the 21 other live ones, and was the 71st registered.
1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.
Browse Psychotic Disorders studies →20 of the 72 studies in Psychotic Disorders with a site in Germany are open now. Recruiting first, the newest first:
University of Oxford · Sites in Germany, Austria, Greece and 6 more countries
Charite University, Berlin, Germany · Sites in Germany
Charite University, Berlin, Germany · Sites in Germany
Technical University of Munich · Sites in Germany
Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Sites in Germany, United States, Argentina and 22 more countries
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 205 Psychotic Disorders studies recruiting now, 53 (26%) set no upper age limit and 143 (70%) stop at 75 or younger; 51 take children under 18; 41 take healthy volunteers.
This study: 16 Years to 35 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
72 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 6 started in 2026.
This study's planned enrollment of 252 is above the median of 65 across 1,320 interventional studies indexed under Psychotic Disorders.
Median enrollment 85 across the 65 interventional studies, 360 across the 7 observational. Of the 40 that completed or were terminated, 7 (18%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 72 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Stephanie Mehl as lead sponsor.
Stephanie Mehl has 1 study filed under Psychotic Disorders — fewer than ten, so there is no comparison to draw.
3 of the studies in Psychotic Disorders with a site in Germany that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06585787Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4) | 2026-11-24 |
| NCT05905003Brigham and Women's HospitalAMP SCZ® Observational Study: PREDICT-DPACC | 2027-04-30 |
| NCT07455929Charite University, Berlin, GermanyFeasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders | 2027-09 |
Among the 72 studies in Psychotic Disorders with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
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.
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.
Time frame: Baseline (t1), 4 weeks (t2); additional assessment at 6-months follow-up (t3)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
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.
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)
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).
Time frame: 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
Time frame: 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).
Time frame: 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 \[15\].
Time frame: 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).
Time frame: Continuously during intervention and follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (t1), 4 weeks (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).
Time frame: During the intervention and at 6-months follow-up (T3)
Not enrolling at this site.
Plan to share: 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.
Started May 2026 (actual). Primary completion is estimated for Sep 2028, 27 months after the start.
Of 455 non-industry interventional studies with no phase under Psychotic Disorders, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 52. This study's planned 27 months is below that.
Counting every sponsor, half of 457 studies reached it within 34 months; a quarter within 19 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.