NCT04730518 Yoga-based Group Intervention (YoGI) for In-patients With Schizophrenia Spectrum Disorders
| NCT ID | NCT04730518 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Psychotic Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 77 participants |
| Start Date | 2021-01-28 |
| Primary Completion | 2025-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 77 participants in total. It began in 2021-01-28 with a primary completion date of 2025-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A rater-blinded randomized controlled trial with a parallel-group design is utilized, comprised of yoga-based group intervention (YoGI) in the experimental condition, and treatment as usual (TAU) in the control condition. The participants in the experimental condition participate in YoGI beside their regular psychiatric treatment (TAU). The intervention is designed for in-patients with schizophrenia spectrum disorders. With the aim of examining the feasibility, acceptability and effectiveness, self-report and blinded rater-based assessments are evaluated before the YoGI (T0), and after four weeks of taking part in intervention (T1). Building on the results of the feasibility and acceptability trial, the study is now progressing to a full randomized controlled trial. The primary outcome for the full trial will be positive symptoms of schizophrenia spectrum disorders, assessed by a blinded rater using the Positive and Negative Syndrome Scale (PANSS). The target sample size has been adjusted to ensure sufficient statistical power, and the trial will evaluate secondary outcomes, including (body) mindfulness, negative symptoms, cognitive functioning, and quality of life, and stress. This study aims to provide robust evidence for the effectiveness of YoGI in comparison to treatment as usual (TAU).
Eligibility Criteria
Inclusion Criteria: * male and female participants * treated as psychiatric inpatients at the psychosis ward or in the social-psychiatric day clinic * ≥18 years * diagnosis of a schizophrenia-spectrum disorder according to the Diagnostical and Statistical Manual 5th edition) and the International Statistical Classification of Diseases and Related Health Problems(ICD-10) code F2 * 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: * a score \> 6, suggesting an acute psychotic episode with severe psychotic symptoms (Peralta\& Cuesta, 1994) * acute suicidality, assessed by item eight of the Calgary Depression Scale for Schizophrenia \> 1 (Addington, Addington, Maticka-Tyndale, \& Joyce, 1992) * any neurological disorders that may affect cognitive functioning * acute substance abuse other than nicotine and prescribed medication * conflicting co-therapy such as electroconvulsive therapy or ketamine treatment
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04730518 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Psychotic Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04730518 currently recruiting?
Yes, NCT04730518 is actively recruiting participants. Contact the research team at Kerem.boege@charite.de for enrollment information.
Where is the NCT04730518 trial being conducted?
This trial is being conducted at Steglitz, Germany.
Who is sponsoring the NCT04730518 clinical trial?
NCT04730518 is sponsored by Charite University, Berlin, Germany. The trial plans to enroll 77 participants.