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Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

RecruitingNAAges 18 Years - 65 YearsAllCharite University, Berlin, Germany
NCT07455929 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 s

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of Schizophrenia Spectrum Disorder by previous (medical) reports according to ICD-10/ DSM-V * Treated as psychiatric outpatients * Age between 18 and 65 years * Ability to give informed consent * Willingness and ability to engage in psychotherapeutic group therapy * 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) Exclusion Criteria: * Neurological disorders and history of severe traumatic brain injury in the past that may affect cognitive functioning * Acute substance dependence, excluding nicotine and prescribed medication * PANSS-P score on one item \> 6 (= very severe) * Ineligibility for group participation * Acute suicidality, indicated by a score \> 1 on item 8 of the Calgary Depression Scale for Schizophrenia (Addington, Addington, Maticka-Tyndale, \& Joyce, 1992) * Conflicting co-therapy such as electroconvulsive therapy or ketamine treatment as well as intensive psychotherapy
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What it tests

  • Yoga-based Group Intervention (YoGI) and treatment as usual (TAU)
  • Strength and Flexibility Training (SFT) and TAU
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Where

1 site
Charité - Universitätsmedizin Berlin Klinik für Psychiatrie und Psychotherapie, Campus Charité Mitte
Berlin, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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