A three-arm pilot rater-blinded randomized controlled trial is conducted, comprising Yoga-based Group Intervention (YoGI + TAU) as the experimental condition, a strength and flexibility training (SFT + TAU) group, and treatment as usual (TAU). Participants in all conditions receive the respective intervention in addition to treatment as usual (TAU) in outpatient settings in Germany. The interventions are designed for patients with schizophrenia spectrum disorders. To examine feasibility, acceptability, and preliminary efficacy, self-report measures and blinded rater-based assessments are administered at baseline (T0), after 12 weeks of participation (T1), and at a 3-month follow-up (T2). Before each intervention session, acute stress (general stress and symptom-related distress) is measured using a visual analogue scale. After each intervention session, acute stress (general stress and symptom-related distress; visual analogue scale), perceived effort (BORG-RPE-Scale), and the occurrence of unpleasant experiences are recorded via self-report, while instructors rate exercise performance and overall participation quality. In addition, semi-structured interviews are conducted at T0 and T1 to assess subjective mechanisms of change and relevant processes.
The primary outcomes of this trial are the feasibility and acceptability of YoGI and the SFT, assessed through recruitment and retention rates, adherence, and participant feedback. Based on recommendations for pilot studies of 20-50 participants, a conservative target sample size of 60 patients was determined. Further, the trial will evaluate secondary outcomes, including (body) mindfulness (SMQ, BMQ), symptoms of depression, anxiety, and stress (DASS, CDSS), positive and negative symptomatology (PANSS), psychological flexibility (CFQ), psychological well-being (WHO-QoL-BREF), social functioning (PSP), subjectively perceived cognitive functioning (SSTICS), and physical activity (SIMPAQ). This study aims to provide preliminary evidence for the efficacy of YoGI in comparison to both SFT and a TAU, and to establish a foundation for a future fully powered randomized controlled trial.
Diagnosis of Schizophrenia Spectrum Disorder by previous (medical) reports according to ICD-10/ DSM-V
Treated as psychiatric outpatients
Age between 18 and 65 years
Ability to give informed consent
Neurological disorders and history of severe traumatic brain injury in the past that may affect cognitive functioning
Acute substance dependence, excluding nicotine and prescribed medication
PANSS-P score on one item > 6 (= very severe)
Ineligibility for group participation
Parallel
Yoga-based Group Intervention (YoGI) and treatment as usual (TAU)
BehavioralYoGI combines breathing exercises (pranayama), sitting, standing and lying positions (asanas), as well as relaxation techniques (shavasana). Participation is also possible from a chair, thereby ensuring accessibility for all patients, irrespective of their physical condition. The 50-minute Yoga-based Group Intervention sessions are conducted once a week over a period of 12 weeks by psychologists or psychotherapists in training who have obtained supplementary certification in yoga therapy. Additionally, study participants receive the standard outpatient care (TAU) provided in Germany.
Strength and Flexibility Training (SFT) and TAU
BehavioralThe SFT intervention is delivered once weekly over a 12-week period. Each 50-minute group session comprises a brief warm-up with mobilization and preparatory exercises, a main phase focused on full-body strengthening and flexibility exercises, and a concluding stretching segment. Participation is also possible from a chair, thereby ensuring accessibility for all patients, irrespective of their physical condition. Sessions are conducted by qualified psychologists or psychotherapists in training in a designated sports facility. The SFT sessions are designed by a psychotherapist in training who has obtained supplementary certification in yoga therapy together with sport therapists.
Proportion of participants 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 participants willing to participate in YoGI (Operational Feasibility)
The number of eligible participants that are willing to participate in YoGI (recruitment)
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)
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
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