Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

Official title

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

Overview

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.

Detailed description

Patients are recruited across Berlin through psychiatric outpatient departments, the outpatient clinics of Charité, and social media. Recruitment occurs either through direct approach by psychologists or psychotherapists in training, or via informational posters and flyers. At baseline, eligibility screening is conducted by a blinded psychologist who is independent of the intervention delivery. This psychologist introduces the study, obtains electronic informed consent, and administers the self-report and clinician-rated assessments.

Given the behavioral nature of the interventions, participants and therapists are informed about group allocation after randomization. Randomization is performed using an Excel-generated list with block randomization (block size = 4).

Data management adheres to standard data protection procedures, including the use of anonymized identification codes and secure storage in an online database accessible only to authorized research team members. Participants retain the right to access their data and to request its deletion at any time. Upon completion of the study, each participant will receive compensation of 50 €.

Interventions

• Behavioral Yoga-based Group Intervention (YoGI) and treatment as usual (TAU)
  YoGI 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. Additi
• Behavioral Strength and Flexibility Training (SFT) and TAU
  The 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 i

Primary outcome measures

• Proportion of participants receiving threshold dose (Acceptability) [Time frame: 18 months]
• Nr. of participants willing to participate in YoGI (Operational Feasibility) [Time frame: 18 months]

Secondary outcome measures (11)

• PANSS Symptomatology - Positive and Negative Symptoms [Time frame: 18 months]
• SMQ Mindfulness [Time frame: 18 months]
• BMQ Body Mindfulness [Time frame: 18 months]
• DASS Symptoms - Depression and Anxiety [Time frame: 18 months]
• CDSS Calgary Depression Scale for Schizophrenia [Time frame: 18 months]
• PSP Personal and Social Performance [Time frame: 18 months]
• CFQ Cognitive Fusion [Time frame: 18 months]
• WHO-QOL-Bref Quality of Life - domains assessed include physical and psychological health, social relationships and environment [Time frame: 18 months]
• SSTICS Subjective Scale to Investigate Cognition in Schizophrenia [Time frame: 18 months]
• Visual Analogue Scales ("Bubbles") [Time frame: During the intervention (12 weeks)]
• BORG-RPE-Scale [Time frame: During the intervention (12 weeks)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Germany · 1 center

• Charité - Universitätsmedizin Berlin Klinik für Psychiatrie und Psychotherapie, Campus Cha — Berlin

Publications

• Tobelmann L, Hahne I, Schulze T, Bergmann N, Fuchs L, Zierhut M, Hahn E, Boge K. Mechanisms of action and processes of yoga-based group intervention for inpatients with schizophrenia spectrum disorders-A longitudinal qualitative study. Front Psychiatry. 2023 Feb 7;14:1086468. doi: 10.3389/fpsyt.2023.1086468. eCollection 2023. PMID 36824673
• Hahne I, Zierhut M, Bergmann N, Hahn E, Ta TMT, Calvano C, Bajbouj M, Boge K. Yoga-Based Group Intervention for Inpatients with Schizophrenia Spectrum Disorders-Feasibility, Acceptability, and Preliminary Outcomes of a Rater-Blinded Randomized Controlled Trial. Schizophr Bull. 2026 Jan 16;52(1):sbae198. doi: 10.1093/schbul/sbae198. PMID 39550215

Identifiers

NCT: NCT07455929 · YOGIA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗