[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627999":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":24,"centralContacts":35,"locations":41,"responsibleParty":57,"collaborators":24,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":24,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":24,"overallStatus":44,"whyStopped":24,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Charite University, Berlin, Germany","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Yoga-based Group Intervention (YoGI)","EXPERIMENTAL","It combines breathing exercises (pranayama), sitting, standing and lying positions (asanas), as well as relaxation techniques (shavasana). Participation is also possible from a chair, thereby ensuring accessibility for all patients, irrespective of their physical condition. The 50-minute Yoga-based Group Intervention sessions are conducted once a week over a period of 12 weeks by psychologists or psychotherapists in training who have obtained supplementary certification in yoga therapy. Additionally, study participants receive the standard outpatient care (TAU) provided in Germany.",[13],"Behavioral: Yoga-based Group Intervention (YoGI) and treatment as usual (TAU)",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Comparator: Strength and Flexibility Training (SFT) and TAU","ACTIVE_COMPARATOR","The SFT intervention is delivered once weekly over a 12-week period. Each 50-minute group session comprises a brief warm-up with mobilization and preparatory exercises, a main phase focused on full-body strengthening and flexibility exercises, and a concluding stretching segment. Participation is also possible from a chair, thereby ensuring accessibility for all patients, irrespective of their physical condition. Sessions are conducted by qualified psychologists or psychotherapists in training in a designated sports facility.\n\nThe SFT sessions are designed by a psychotherapist in training who has obtained supplementary certification in yoga therapy together with sport therapists.",[19],"Behavioral: Strength and Flexibility Training (SFT) and TAU",{"label":21,"type":22,"description":23,"interventionNames":24},"No Intervention: Treatment as usual","NO_INTERVENTION","Participants assigned to this group receive treatment as usual (TAU) for 12 weeks. During this period, there is no contact, except for a follow-up at 8 weeks to inform them about the next steps for T1.",null,[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":24},"BEHAVIORAL","Yoga-based Group Intervention (YoGI) and treatment as usual (TAU)","YoGI combines breathing exercises (pranayama), sitting, standing and lying positions (asanas), as well as relaxation techniques (shavasana). Participation is also possible from a chair, thereby ensuring accessibility for all patients, irrespective of their physical condition. The 50-minute Yoga-based Group Intervention sessions are conducted once a week over a period of 12 weeks by psychologists or psychotherapists in training who have obtained supplementary certification in yoga therapy. Additionally, study participants receive the standard outpatient care (TAU) provided in Germany.",[9],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":24},"Strength and Flexibility Training (SFT) and TAU","The SFT intervention is delivered once weekly over a 12-week period. Each 50-minute group session comprises a brief warm-up with mobilization and preparatory exercises, a main phase focused on full-body strengthening and flexibility exercises, and a concluding stretching segment. Participation is also possible from a chair, thereby ensuring accessibility for all patients, irrespective of their physical condition. Sessions are conducted by qualified psychologists or psychotherapists in training in a designated sports facility. The SFT sessions are designed by a psychotherapist in training who has obtained supplementary certification in yoga therapy together with sport therapists.",[15],[36],{"name":37,"role":38,"phone":39,"phoneExt":24,"email":40},"Kerem Böge, Prof. Dr. Dr.","CONTACT","+4930450517319","kerem.boege@charite.de",[42],{"facility":43,"status":44,"city":45,"state":24,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Charité - Universitätsmedizin Berlin Klinik für Psychiatrie und Psychotherapie, Campus Charité Mitte","RECRUITING","Berlin","10117","Germany","DE",{"type":50,"coordinates":51},"Point",[52,53],13.41053,52.52437,{"lat":53,"lon":52},[56],{"name":37,"role":38,"phone":39,"phoneExt":24,"email":40},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Kerem Böge","Prof. Dr. Dr.","100627999","feasibility-acceptability-and-preliminary-efficacy-of-yoga-based-group-intervention-for-outpatients-with-schizophrenia-spectrum-disorders-100627999",false,"NCT07455929","Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders","Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders (YOGIA Study) - a Three-arm, Single-blind Randomized Controlled Pilot Study","YOGIA","Inclusion Criteria:\n\n* Diagnosis of Schizophrenia Spectrum Disorder by previous (medical) reports according to ICD-10\u002F DSM-V\n* Treated as psychiatric outpatients\n* Age between 18 and 65 years\n* Ability to give informed consent\n* Willingness and ability to engage in psychotherapeutic group therapy\n* Low to moderate psychotic state indicated with a score of ≤ 6 for each item at the Positive scale of the Positive and Negative Syndrome Scale (PANSS, Peralta \\& Cuesta, 1994)\n\nExclusion Criteria:\n\n* Neurological disorders and history of severe traumatic brain injury in the past that may affect cognitive functioning\n* Acute substance dependence, excluding nicotine and prescribed medication\n* PANSS-P score on one item \\> 6 (= very severe)\n* Ineligibility for group participation\n* Acute suicidality, indicated by a score \\> 1 on item 8 of the Calgary Depression Scale for Schizophrenia (Addington, Addington, Maticka-Tyndale, \\& Joyce, 1992)\n* Conflicting co-therapy such as electroconvulsive therapy or ketamine treatment as well as intensive psychotherapy","ALL","18 Years","65 Years",{"count":73,"type":74},60,"ESTIMATED","INTERVENTIONAL",[77],"NA","A three-arm pilot rater-blinded randomized controlled trial is conducted, comprising Yoga-based Group Intervention (YoGI + TAU) as the experimental condition, a strength and flexibility training (SFT + TAU) group, and treatment as usual (TAU). Participants in all conditions receive the respective intervention in addition to treatment as usual (TAU) in outpatient settings in Germany. The interventions are designed for patients with schizophrenia spectrum disorders. To examine feasibility, acceptability, and preliminary efficacy, self-report measures and blinded rater-based assessments are administered at baseline (T0), after 12 weeks of participation (T1), and at a 3-month follow-up (T2). Before each intervention session, acute stress (general stress and symptom-related distress) is measured using a visual analogue scale. After each intervention session, acute stress (general stress and symptom-related distress; visual analogue scale), perceived effort (BORG-RPE-Scale), and the occurrence of unpleasant experiences are recorded via self-report, while instructors rate exercise performance and overall participation quality. In addition, semi-structured interviews are conducted at T0 and T1 to assess subjective mechanisms of change and relevant processes.\n\nThe primary outcomes of this trial are the feasibility and acceptability of YoGI and the SFT, assessed through recruitment and retention rates, adherence, and participant feedback. Based on recommendations for pilot studies of 20-50 participants, a conservative target sample size of 60 patients was determined. Further, the trial will evaluate secondary outcomes, including (body) mindfulness (SMQ, BMQ), symptoms of depression, anxiety, and stress (DASS, CDSS), positive and negative symptomatology (PANSS), psychological flexibility (CFQ), psychological well-being (WHO-QoL-BREF), social functioning (PSP), subjectively perceived cognitive functioning (SSTICS), and physical activity (SIMPAQ). This study aims to provide preliminary evidence for the efficacy of YoGI in comparison to both SFT and a TAU, and to establish a foundation for a future fully powered randomized controlled trial.",[80,81],"Psychotic Disorders","Schizophrenia Spectrum Disorders","2026-03-09",{"date":84,"type":85},"2026-03-11","ACTUAL",{"date":87,"type":74},"2026-03",{"date":89,"type":74},"2028-03",{"name":5,"class":6},1]