Yoga-based group intervention for in-patients with schizophrenia spectrum disorders
Yoga-based Group Intervention for In-Patients With Schizophrenia Spectrum Disorder - a Rater-Blinded Randomized Controlled Trial
This study is testing if a yoga program can help in-patients with schizophrenia feel better when combined with their regular treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 77 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Steglitz, State of Berlin) |
| Trial ID | NCT04730518 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a yoga-based group intervention (YoGI) for in-patients diagnosed with schizophrenia spectrum disorders. Participants will engage in YoGI alongside their usual psychiatric treatment, with assessments conducted before and after the intervention period to measure outcomes. The study employs a rater-blinded randomized controlled design to ensure unbiased results, focusing on the primary outcome of positive symptoms as measured by the Positive and Negative Syndrome Scale (PANSS). Saliva samples will also be collected to analyze stress-related biomarkers, contributing to a comprehensive understanding of the intervention's impact.
Who should consider this trial
Good fit: Ideal candidates are male and female in-patients aged 18 and older with a diagnosis of a schizophrenia spectrum disorder who can provide informed consent and engage in group therapy.
Not a fit: Patients experiencing acute psychotic episodes or severe psychotic symptoms, as well as those with acute suicidality or neurological disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a complementary therapeutic approach to improve the management of schizophrenia spectrum disorders.
How similar studies have performed: While the approach of using yoga as an intervention for psychotic disorders is relatively novel, preliminary studies have suggested potential benefits, indicating a promising area for further exploration.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Steglitz, State of Berlin
- Charité Universitätsmedizin Berlin, Campus Benjamin Franklin — Steglitz, State of Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: Kerem Böge, Dr.
- Email: Kerem.boege@charite.de
- Phone: 0049 30 450 517 789
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.