Yoga-based Group Intervention (YoGI) for In-patients With Schizophrenia Spectrum Disorders
Recruiting · NCT04730518 · Interventional (participants receive a specific treatment) · Lead sponsor: Charite University, Berlin, Germany
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
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 it is running
1 location listed.
- Charité Universitätsmedizin Berlin, Campus Benjamin Franklin - Steglitz, State of Berlin, Germany