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).
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
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
Parallel
Yoga-based group intervention (YoGI)
Behavioralsee above
PANSS Symptomatology - Positive and Negative Symptoms
Positive Symptoms as measure by the Positive and Negative Syndrome Scale (PANSS) to assess symptoms on a scale from 1 (non-existent) to 7 (extremely severe, 14 questions)
Proportion of pp receiving threshold dose (Acceptability)
The proportions of participants receiving a threshold dose of the intervention (50% or more) and the proportion of participants with outcome measures at post-intervention and data completion. (Adherence and retention rate)
Nr. of pp willing to participate in YoGI (Operational Feasibility)
The number of eligible participants that are willing to participate in YoGI (recruitment)
SMQ Mindfulness
Southampton mindfulness questionnaire (SMQ), 16 items on a scale from 1 (applies fully) to 7 (does not apply at all)
BMQ Body Mindfulness
Body Mindfulness Questionnaire (BMQ), 14 items on a scale from 1 (not at all) to (5) every day
DASS Symptoms - Depression and Anxiety
Depression Anxiety Stress Scales (DASS), 21 questions that can be answered on a scale from 0 (does not apply to me) to 3 (applies to me strongly/most of the time)
PSP Personal and Social Performance
Personal and Social Performance Scale (PSP), Interview measures personal and social functioning in the domains of: Socially useful activities (eg, work and study), Personal and social relationships, Self-care, Disturbing and aggressive behaviors. Different domains are rated on a scale from absent to highly severe.
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