[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642980":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":40,"locations":49,"responsibleParty":210,"collaborators":214,"id":234,"slug":235,"hasResults":236,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":236,"sex":242,"minAge":243,"maxAge":244,"enrollmentInfo":245,"targetDuration":26,"studyType":248,"phases":249,"briefSummary":251,"conditions":252,"keywords":260,"overallStatus":52,"whyStopped":26,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":281},{"fullName":5,"class":6},"Berlin Institute of Health @ Charité","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: FEEL GOOD",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Other: Treatment as Usual (TAU)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.",[15],[32,36],{"name":33,"affiliation":34,"role":35},"Andreas Bechdolf, Prof. Dr.","Department of Psychiatry and Psychotherapy, CCM, Charité-Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin, Germany","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":39},"Stephanie Mehl, Prof. Dr.","Marburg University, Department of Psychiatry and Psychotherapy, Rudolf-Bultmann-Strasse 8,35039 Marburg, Germany","STUDY_CHAIR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":26,"email":45},"Mara Bach","CONTACT","+49 (0) 130 226095","Mara.bach@charite.de",{"name":47,"role":43,"phone":44,"phoneExt":26,"email":48},"Aisha J. L. Munk, PD Dr.","Aisha.munk@charite.de",[50,74,91,113,132,153,174,193],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"University of Mannheim, Central Institute of Mental Health, Department of Psychiatry and Psychotherapy, J5, 68169 Mannheim","RECRUITING","Mannheim","Baden-Wurttemberg","68159","Germany","DE",{"type":59,"coordinates":60},"Point",[61,62],8.46694,49.4891,{"lat":62,"lon":61},[65,69,71],{"name":66,"role":43,"phone":67,"phoneExt":26,"email":68},"Lana Wölfl","0049 (0) 621 1703 0","Lana.Woelfl@zi-mannheim.de",{"name":70,"role":35,"phone":26,"phoneExt":26,"email":26},"Andreas Meyer-Lindenberg, Prof. Dr.",{"name":72,"role":73,"phone":26,"phoneExt":26,"email":26},"Dusan Hirjak, Prof. Dr.","SUB_INVESTIGATOR",{"facility":75,"status":52,"city":76,"state":77,"zip":78,"country":56,"countryCode":57,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"University of Augsburg, Department of Psychiatry and Psychotherapy, Geschwister-Schoenert-Str. 1, 86156 Augsburg","Augsburg","Bavaria","86156",{"type":59,"coordinates":80},[81,82],10.89851,48.37154,{"lat":82,"lon":81},[85,89],{"name":86,"role":43,"phone":87,"phoneExt":26,"email":88},"Benjamin Pross, Dr.","+49 (0) 821 4803 1600","benjamin.pross@bkh-augsburg.de",{"name":90,"role":35,"phone":26,"phoneExt":26,"email":26},"Alkomiet Hasan, Prof. Dr.",{"facility":92,"status":52,"city":93,"state":77,"zip":94,"country":56,"countryCode":57,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Ludwig-Maximilians Universität Munich, Department of Psychiatry and Psychotherapy, Nussbaumstr. 7, 80336 Munich","München","80336",{"type":59,"coordinates":96},[97,98],13.46314,48.69668,{"lat":98,"lon":97},[101,105,109,111],{"name":102,"role":43,"phone":103,"phoneExt":26,"email":104},"Simone Sachenbacher, Dr.","+49 (0) 89 4400 52779","Simone.Sachenbacher@med.uni-muenchen.de",{"name":106,"role":43,"phone":107,"phoneExt":26,"email":108},"Isabel Maurus, PD Dr.","+49 (0) 89 4400 53596","isabel.maurus@med.uni-muenchen.de",{"name":110,"role":35,"phone":26,"phoneExt":26,"email":26},"Peter Falkai, Prof. Dr.",{"name":112,"role":73,"phone":26,"phoneExt":26,"email":26},"Oliver Pogarell, Prof. Dr.",{"facility":114,"status":52,"city":115,"state":116,"zip":117,"country":56,"countryCode":57,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"University of Hamburg, Universitätsklinikum Hamburg-Eppendorf Hamburg, Department of Psychiatry and Psychotherapy","Hamburg","Free and Hanseatic City of Hamburg","20246",{"type":59,"coordinates":119},[120,121],9.99302,53.55073,{"lat":121,"lon":120},[124,128,130],{"name":125,"role":43,"phone":126,"phoneExt":26,"email":127},"Schirin Gellert","+49 (0) 40 7410 53210","S.Gellert@uke.de",{"name":129,"role":35,"phone":26,"phoneExt":26,"email":26},"Jürgen Gallinat, Prof. Dr.",{"name":131,"role":73,"phone":26,"phoneExt":26,"email":26},"Martin Lambert, Prof. Dr.",{"facility":133,"status":52,"city":134,"state":135,"zip":136,"country":56,"countryCode":57,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Marburg University, Department of Psychiatry and Psychotherapy, Rudolf-Bultmann-Str. 8, 35039 Marburg, Germany","Marburg","Hesse","35039",{"type":59,"coordinates":138},[139,140],8.77069,50.80904,{"lat":140,"lon":139},[143,147,150,152],{"name":144,"role":43,"phone":145,"phoneExt":26,"email":146},"Igor Nenadiç, Prof. Dr","+49 (0) 6421 58 65002","nenadic@uni-marburg.de",{"name":37,"role":43,"phone":148,"phoneExt":26,"email":149},"+49 (0)6421 58 65200","stephanie.mehl@uni-marburg.de",{"name":151,"role":35,"phone":26,"phoneExt":26,"email":26},"Igor Nenadiç, Prof. Dr.",{"name":37,"role":73,"phone":26,"phoneExt":26,"email":26},{"facility":154,"status":52,"city":155,"state":156,"zip":157,"country":56,"countryCode":57,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"University of Cologne, Department of Psychiatry and Psychotherapy, Kerpener Str. 62, 50937 Cologne","Cologne","North Rhine-Westphalia","50937",{"type":59,"coordinates":159},[160,161],6.95,50.93333,{"lat":161,"lon":160},[164,168,171,173],{"name":165,"role":43,"phone":166,"phoneExt":26,"email":167},"Paula Mengelkamp","+49 (0) 221 478 87291","paula.mengelkamp1@uk-koeln.de",{"name":169,"role":43,"phone":166,"phoneExt":26,"email":170},"Joseph Kambeitz, Prof. Dr.","joseph.kambeitz@uk-koeln.de",{"name":172,"role":35,"phone":26,"phoneExt":26,"email":26},"Frank Jessen, Prof. Dr.",{"name":169,"role":73,"phone":26,"phoneExt":26,"email":26},{"facility":175,"status":52,"city":176,"state":177,"zip":178,"country":56,"countryCode":57,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Charité-Universitätsmedizin Berlin (CCM), Department of Psychiatry and Psychotherapy, , Charitéplatz 1, D-10117 Berlin, Germany","Berlin","State of Berlin","10117",{"type":59,"coordinates":180},[181,182],13.41053,52.52437,{"lat":182,"lon":181},[185,189,191],{"name":186,"role":43,"phone":187,"phoneExt":26,"email":188},"Kerem Böge, Prof. Dr. Dr","+49 (0) 30 450 517 319","kerem.boege@charite.de",{"name":190,"role":35,"phone":26,"phoneExt":26,"email":26},"Malek Bajbouj, Prof. Dr.",{"name":192,"role":73,"phone":26,"phoneExt":26,"email":26},"Kerem Böge, Prof. Dr. Dr.",{"facility":194,"status":52,"city":176,"state":177,"zip":195,"country":56,"countryCode":57,"cosmosGeoPoint":196,"geoPoint":198,"contacts":199},"Vivantes Klinikum am Urban, Hospital for Psychiatry, Psychotherapy und Psychosomatics, Dieffenbachstr. 1, 10967 Berlin","10967",{"type":59,"coordinates":197},[181,182],{"lat":182,"lon":181},[200,203,207,208],{"name":33,"role":43,"phone":201,"phoneExt":26,"email":202},"+49 (0) 30 130 22 60 01","andreas.bechdolf@vivantes.de",{"name":204,"role":43,"phone":205,"phoneExt":26,"email":206},"Aisha J.L. Munk, PD Dr.","+49 (0) 30 130 226095","aisha.munk@vivantes.de",{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":209,"role":73,"phone":26,"phoneExt":26,"email":26},"Anja Lehmann, Dr.",{"type":211,"investigatorFullName":212,"investigatorTitle":213,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Stephanie Mehl","Co-Principal Investigator",[215,217,219,221,223,225,227,229,232],{"name":216,"class":6},"German Research Foundation",{"name":218,"class":6},"Universitätsklinikum Hamburg-Eppendorf",{"name":220,"class":6},"Central Institute of Mental Health, Mannheim",{"name":222,"class":6},"University Hospital Augsburg",{"name":224,"class":6},"Ludwig-Maximilians - University of Munich",{"name":226,"class":6},"Charite University, Berlin, Germany",{"name":228,"class":6},"University Hospital of Cologne",{"name":230,"class":231},"Vivantes Klinikum am Urban","UNKNOWN",{"name":233,"class":6},"Philipps University Marburg","100642980","feel-good-a-multicenter-trial-of-a-mindfulness-based-group-therapy-in-young-adults-with-early-psychosis-100642980",false,"NCT07645443","FEEL-GOOD: A Multicenter Trial of a Mindfulness-Based Group Therapy in Young Adults With Early Psychosis","Mindfulness-based Group Therapy in Young Inpatients With Acute Early Psychosis (FEEL-GOOD)","FEEL-GOOD","Inclusion Criteria:\n\n* Age 16 to 35 years\n* 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)\n* 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\u002Fday clinic treatment with a planned stay of at least 4 weeks\n* Interested in and willing to participate in FEEL-GOOD and\u002For TAU.\n\nExclusion Criteria:\n\n* Insufficient German language abilities\n* Acute suicidality or acute threat to others","ALL","16 Years","35 Years",{"count":246,"type":247},252,"ESTIMATED","INTERVENTIONAL",[250],"NA","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).",[253,254,255,256,257,258,259],"Early Onset Psychosis","First Psychotic Episode Within the Last 5 Years","First-episode Psychosis","Schizophrenia Spectrum Disorders (SSD)","Psychosis","Psychosis NOS","Randomized Controlled Trial (RCT)",[261,262,263,264,265,266,267,268,269,257,270,271],"Randomized controlled trial","Emotion regulation","Ecological momentary assessment","Early psychosis","First-episode psychosis","Mindfulness-based intervention","PANSS","EMA","Schizophrenia spectrum disorder","Mindfulness","observer-rated","2026-06-09",{"date":274,"type":275},"2026-06-12","ACTUAL",{"date":277,"type":275},"2026-05-27",{"date":279,"type":247},"2028-12-31",{"name":212,"class":6},8]