NCT07455929 Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders
| NCT ID | NCT07455929 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Psychotic Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-03 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-03 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07455929 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Psychotic Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07455929 currently recruiting?
Yes, NCT07455929 is actively recruiting participants. Contact the research team at kerem.boege@charite.de for enrollment information.
Where is the NCT07455929 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT07455929 clinical trial?
NCT07455929 is sponsored by Charite University, Berlin, Germany. The trial plans to enroll 60 participants.