Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07455929

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

Led by Charite University, Berlin, Germany · Updated on 2026-03-11

60

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial investigates the feasibility, acceptability, and preliminary effects of a Yoga-based Group Intervention (YoGI) compared to Strength and Flexibility Training (SFT) and treatment as usual (TAU) for outpatients with schizophrenia spectrum disorders. The study is designed as a three-arm, single-blind randomized controlled pilot trial to provide initial evidence and inform future larger studies. It evaluates patients with psychotic disorders using various self-reports and blinded assessments to measure mental health, mindfulness, symptoms, and social functioning. Participants are randomly assigned to one of three groups: YoGI plus TAU, SFT plus TAU, or TAU alone. YoGI consists of weekly 50-minute sessions for 12 weeks involving breathing exercises, yoga postures, and relaxation techniques accessible to all physical abilities. SFT also meets weekly for 50 minutes over 12 weeks and includes warm-up, strengthening, flexibility exercises, and stretching, also adaptable for all participants. The TAU group continues their usual outpatient care without additional intervention during the study period. Throughout the 12-week intervention and follow-up, participants complete assessments at baseline, after 12 weeks, and three months later. Researchers collect data on acute stress, perceived effort, and unpleasant experiences during each session, as well as ratings of exercise performance and participation quality. The study measures outcomes like symptom severity, mindfulness, depression, anxiety, psychological well-being, social function, cognitive function, and physical activity. Participants’ data are securely managed, and they receive compensation for completing the study.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of schizophrenia spectrum disorder by previous medical reports according to ICD-10 or 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 with a score of 6 or less on each item of the Positive scale of the PANSS
Not Eligible

You will not qualify if you...

  • Neurological disorders or history of severe traumatic brain injury affecting cognition
  • Acute substance dependence excluding nicotine and prescribed medication
  • Very severe psychotic symptoms with a PANSS positive item score greater than 6
  • Ineligibility for group participation
  • Acute suicidality indicated by a score greater than 1 on item 8 of the Calgary Depression Scale for Schizophrenia
  • Conflicting co-therapy such as electroconvulsive therapy, ketamine treatment, or intensive psychotherapy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility screening, informed consent, and baseline assessments

Outpatient Group Intervention

Duration - 12 weeks

Participants engage in weekly 50-minute group sessions of either Yoga-based Group Intervention or Strength and Flexibility Training, designed to be accessible regardless of physical condition. These sessions are conducted by trained psychologists or psychotherapists. Participants continue to receive treatment as usual during this time.

Weekly group sessions (in-person) for 12 weeks

Follow-up

Duration - Up to 18 months

Participants assigned to treatment as usual without additional group sessions have a follow-up contact at 8 weeks to discuss next steps. All participants may have assessments to monitor outcomes after the intervention period.

1 follow-up visit at 8 weeks and additional assessments during follow-up period

Trial Site Locations

Total: 1 location

1

Charité - Universitätsmedizin Berlin Klinik für Psychiatrie und Psychotherapie, Campus Charité Mitte

Berlin, Germany, 10117

Actively Recruiting

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Research Team

K

Kerem Böge, Prof. Dr. Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Mechanisms of action and processes of yoga-based group intervention for inpatients with schizophrenia spectrum disorders-A longitudinal qualitative study.

Laura Töbelmann, Inge Hahne, Theresa Schulze...

https://pubmed.ncbi.nlm.nih.gov/36824673

Yoga-Based Group Intervention for Inpatients with Schizophrenia Spectrum Disorders-Feasibility, Acceptability, and Preliminary Outcomes of a Rater-Blinded Randomized Controlled Trial.

Inge Hahne, Marco Zierhut, Niklas Bergmann...

https://pubmed.ncbi.nlm.nih.gov/39550215