RecruitingNot ApplicableNCT04730518

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

Sponsor

Charite University, Berlin, Germany

Enrollment

77 participants

Start Date

Jan 28, 2021

Study Type

INTERVENTIONAL

Conditions

Psychotic Disorders

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria7

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 Criteria5

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