Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT04730518

Yoga-based Group Intervention (YoGI) for In-patients With Schizophrenia Spectrum Disorders

Led by Charite University, Berlin, Germany · Updated on 2025-02-24

77

Participants Needed

1

Research Sites

256 weeks

Total Duration

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AI-Summary

What this Trial Is About

A rater-blinded randomized controlled trial with a parallel-group design is utilized, comprised of yoga-based group intervention (YoGI) in the experimental condition, and treatment as usual (TAU) in the control condition. The participants in the experimental condition participate in YoGI beside their regular psychiatric treatment (TAU). The intervention is designed for in-patients with schizophrenia spectrum disorders. With the aim of examining the feasibility, acceptability and effectiveness, self-report and blinded rater-based assessments are evaluated before the YoGI (T0), and after four weeks of taking part in intervention (T1). Building on the results of the feasibility and acceptability trial, the study is now progressing to a full randomized controlled trial. The primary outcome for the full trial will be positive symptoms of schizophrenia spectrum disorders, assessed by a blinded rater using the Positive and Negative Syndrome Scale (PANSS). The target sample size has been adjusted to ensure sufficient statistical power, and the trial will evaluate secondary outcomes, including (body) mindfulness, negative symptoms, cognitive functioning, and quality of life, and stress. This study aims to provide robust evidence for the effectiveness of YoGI in comparison to treatment as usual (TAU).

CONDITIONS

Official Title

Yoga-based Group Intervention (YoGI) for In-patients With Schizophrenia Spectrum Disorders

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female participants
  • Treated as psychiatric inpatients at the psychosis ward or in the social-psychiatric day clinic
  • 18 years of age or older
  • Diagnosis of schizophrenia-spectrum disorder according to DSM-5 and ICD-10 code F2
  • Ability to give informed consent
  • Willingness and ability to engage in psychotherapeutic group therapy
  • Low to moderate psychotic state with scores of 6 or less on each item of the Positive scale of the PANSS
Not Eligible

You will not qualify if you...

  • Score greater than 6 indicating an acute psychotic episode with severe symptoms
  • Acute suicidality with a score higher than 1 on item eight of the Calgary Depression Scale for Schizophrenia
  • Any neurological disorders affecting cognitive functioning
  • Acute substance abuse other than nicotine and prescribed medication
  • Conflicting co-therapy such as electroconvulsive therapy or ketamine treatment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Charité Universitätsmedizin Berlin, Campus Benjamin Franklin

Steglitz, State of Berlin, Germany, 1220

Actively Recruiting

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Research Team

K

Kerem Böge, Dr.

CONTACT

E

Eric Hahn, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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