NCT04730518Recruiting
Yoga-based Group Intervention (YoGI) for In-patients With Schizophrenia Spectrum Disorders
Yoga-based Group Intervention for In-Patients With Schizophrenia Spectrum Disorder - a Rater-Blinded Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 24 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 77 (estimated)
- First submitted
- 26 Jan 2021
- Start date
- 28 Jan 2021
- Primary completion date
- 30 Jul 2025
- Lead sponsor
- Charite University, Berlin, Germany
- Diseases
- Schizophrenia
- NCT number
- NCT04730518
What you commit to
- Study type: Interventional
- Planned participants: 77
- From 28 Jan 2021 to the primary completion date, 30 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- acute substance abuse other than nicotine and prescribed medication
- conflicting co-therapy such as electroconvulsive therapy or ketamine treatment
Other illness
- any neurological disorders that may affect cognitive functioning
Other
- 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)
Who the study is looking for
- 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)
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charité Universitätsmedizin Berlin, Campus Benjamin Franklin Coordinator of this site? Confirm its status | Steglitz | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.