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NCT Number: NCT04730518

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

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).

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité Universitätsmedizin Berlin, Campus Benjamin Franklin

Steglitz, State of Berlin, 1220, Germany

Location status: Recruiting

Location contact

Kerem Böge, Dr.

CONTACT

[email protected]

4930450517789

About this study

Psychiatrists and psychologists at the ward for psychotic disorders identify eligible participants and invite them to participate in the study. An eligibility screening is held by the study assistant at baseline, introducing the study, providing informed electronic consent, as well as conducting the self-report measures and app-based assessments. A blinded psychologist who works independently of the (co-) psychologist conducts the remaining rater-questionnaires. Due to the psychotherapeutic nature of the study, information about the treatment allocation had to be shared with the co-psychologist and the participants. Saliva samples are also taken to examine stress-related biomarkers. Randomization was conducted by the Random Group Generator (pubmed, 2018). The data management plan includes standard procedures for data-handling such as using anonymized identification codes for patient data. The participants have the right to access their data, and the right to claim an annihilation. The data is being saved in an online database, only allowing researchers involved in the study to access the data.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male and female participants
  • treated as psychiatric inpatients at the psychosis ward or in the social-psychiatric day clinic
  • ≥18 years
  • diagnosis of a schizophrenia-spectrum disorder according to the Diagnostical and Statistical Manual 5th edition) and the International Statistical Classification of Diseases and Related Health Problems(ICD-10) code F2
  • 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

  • a score > 6, suggesting an acute psychotic episode with severe psychotic symptoms (Peralta& Cuesta, 1994)
  • acute suicidality, assessed by item eight of the Calgary Depression Scale for Schizophrenia > 1 (Addington, Addington, Maticka-Tyndale, & Joyce, 1992)
  • any neurological disorders that may affect cognitive functioning
  • acute substance abuse other than nicotine and prescribed medication
  • conflicting co-therapy such as electroconvulsive therapy or ketamine treatment

Treatment and study plan

Yoga-based group intervention (YoGI)

Behavioral

see above

Primary outcomes

  1. PANSS Symptomatology - Positive and Negative Symptoms

    Time frame: 18 months

    Positive Symptoms as measure by the Positive and Negative Syndrome Scale (PANSS) to assess symptoms on a scale from 1 (non-existent) to 7 (extremely severe, 14 questions)

  2. Proportion of pp receiving threshold dose (Acceptability)

    Time frame: 18 months

    The proportions of participants receiving a threshold dose of the intervention (50% or more) and the proportion of participants with outcome measures at post-intervention and data completion. (Adherence and retention rate)

  3. Nr. of pp willing to participate in YoGI (Operational Feasibility)

    Time frame: 18 months

    The number of eligible participants that are willing to participate in YoGI (recruitment)

Secondary outcomes

  1. SMQ Mindfulness

    Time frame: 18 months

    Southampton mindfulness questionnaire (SMQ), 16 items on a scale from 1 (applies fully) to 7 (does not apply at all)

  2. BMQ Body Mindfulness

    Time frame: 18 months

    Body Mindfulness Questionnaire (BMQ), 14 items on a scale from 1 (not at all) to (5) every day

  3. DASS Symptoms - Depression and Anxiety

    Time frame: 18 months

    Depression Anxiety Stress Scales (DASS), 21 questions that can be answered on a scale from 0 (does not apply to me) to 3 (applies to me strongly/most of the time)

  4. PSP Personal and Social Performance

    Time frame: 18 months

    Personal and Social Performance Scale (PSP), Interview measures personal and social functioning in the domains of: Socially useful activities (eg, work and study), Personal and social relationships, Self-care, Disturbing and aggressive behaviors. Different domains are rated on a scale from absent to highly severe.

  5. CFQ Cognitive Fusion

    Time frame: 18 months

    Cognitive Fusion Questionnaire (CFQ), 7 questions that can be answered on a scale from 1(not applicable) to 7 (applies always)

  6. WHO-QOL-Bref Quality of Life - domains assessed include physical and psychological health, social relationships and environment

    Time frame: 18 months

    World Health Organisation Quality of Life (WHO-QOL-Bref) to assess quality of life measured on a scale from 1 (never) to 5 (always). Facets incorporated in the 4 domains: 1. Physical health - Activities of daily living Dependence on medicinal substances and medical aids Energy and fatigue Mobility Pain and discomfort Sleep and rest Work Capacity; 2. Psychological - Bodily image and appearance Negative feelings Positive feelings Self-esteem Spirituality / Religion / Personal beliefs Thinking, learning, memory and concentration; 3. Social relationships - Personal relationships Social support Sexual activity; 4. Environment - Financial resources Freedom, physical safety and security Health and social care: accessibility and quality Home environment Opportunities for acquiring new information and skills Participation in and opportunities for recreation / leisure activities Physical environment (pollution / noise / traffic / climate) Transport.

  7. CANTAB Broad Cognitive Functioning

    Time frame: 18 months

    CANTAB mobile App to assess cognitive functioning, validated version for schizophrenia

  8. SSTICS Subjective Cognitive Functioning

    Time frame: 18 months

    Subjective Scale to Investigate Cognition (SSTICS), 21 items from a scale from 1 to 5.

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Hahn, Dr.

CONTACT

[email protected]

0049 30 450 517 547

Kerem Böge, Dr.

CONTACT

[email protected]

0049 30 450 517 789

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Yoga-based Group Intervention for In-Patients With Schizophrenia Spectrum Disorder - a Rater-Blinded Randomized Controlled Trial

Acronym: YING

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2021
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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