Yoga-based group program plus usual care for outpatients with schizophrenia spectrum disorders

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders (YOGIA Study) - a Three-arm, Single-blind Randomized Controlled Pilot Study

This project will see if a 12-week yoga-based group program added to usual outpatient care helps adults with schizophrenia spectrum disorders reduce stress and symptom-related distress compared with exercise or usual care alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Charite University, Berlin, Germany (Academic / other)
• Locations: 1 site (Berlin)
• Trial ID: NCT07455929 on ClinicalTrials.gov

What this trial studies

A three-arm, rater-blinded randomized pilot in Berlin compares a yoga-based group intervention plus treatment as usual (YoGI + TAU) to strength and flexibility training plus TAU (SFT + TAU) and to TAU alone. Participants are psychiatric outpatients aged 18–65 with a schizophrenia spectrum diagnosis and low-to-moderate psychotic symptoms, randomized in blocks and informed of group allocation after randomization. Self-report and blinded clinician ratings are collected at baseline, after 12 weeks, and at a 3-month follow-up, and acute stress and perceived effort are measured before and after each session. Recruitment, consent, and assessments are managed by blinded psychologists at Charité and participants receive €50 upon completion.

Who should consider this trial

Good fit: Ideal candidates are psychiatric outpatients aged 18–65 with a diagnosed schizophrenia spectrum disorder who can give informed consent, participate in group therapy, and have low-to-moderate positive symptoms (PANSS positive items ≤6).

Not a fit: Patients with very severe psychotic symptoms (PANSS item >6), acute suicidality, acute substance dependence, major neurological injury, or inability to join group sessions are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could offer a low-cost, group-based option to reduce acute stress and symptom-related distress and support daily functioning for outpatients with schizophrenia spectrum disorders.

How similar studies have performed: Previous small trials of yoga for schizophrenia and related disorders have shown promising stress and symptom reductions but the evidence is still limited and mixed.

Eligibility criteria

Inclusion Criteria:

* 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
* 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:

* 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
* Acute suicidality, indicated by a score \> 1 on item 8 of the Calgary Depression Scale for Schizophrenia (Addington, Addington, Maticka-Tyndale, \& Joyce, 1992)
* Conflicting co-therapy such as electroconvulsive therapy or ketamine treatment as well as intensive psychotherapy

Where this trial is running

Berlin

• Charité - Universitätsmedizin Berlin Klinik für Psychiatrie und Psychotherapie, Campus Charité Mitte — Berlin, Germany (Recruiting)

Study contacts

• Study coordinator: Kerem Böge, Prof. Dr. Dr.

Conditions Psychotic Disorders; Schizophrenia Spectrum Disorders