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

NCT ID: NCT04730518

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-28
• Study Completion Date: 2025-12-30

Brief Summary

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).

Detailed Description

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.

Conditions

Psychotic Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Yoga-based Group Intervention (YoGI)

The yoga-based group intervention (YoGI) involves a four-week intervention with weekly group therapy sessions in addition to TAU. The fifty-minute session takes place with a group size of max. 10 participants and was held once a week by a psychologist who is also a trained yoga-teacher.

A yoga session starts with breathing exercises (pranayama), followed by various exercises in standing, sitting and lying down (asanas), which are accompanied by mindful instructions from the psychologist. Every yoga session ends with a final relaxation (shavasana), which can take the form of a body scan, for example.

Group Type: EXPERIMENTAL

Yoga-based group intervention (YoGI)

Intervention Type: BEHAVIORAL

see above

Treatment as usual (TAU)

Treatment as usual (TAU) at the ward consists of a variety of daily group therapies the patients partake in. Every patient at the ward receives a daily schedule depending on individual needs for therapy. The therapies offered at the ward include occupational therapy, physiotherapy, psychoeducative groups, and concentration practice of two levels, all not related to mindfulness interventions. In addition to the group activities at the ward, every patient receives individual psychotherapy sessions (CBTp) at least once a week, held by a certified psychiatrist or psychologist. Psychopharmacological treatment is provided by the physicians, and social workers are available in order to support patients in managing their everyday lives after the stationary treatment. Weekly group meetings at the ward, together with the treating physicians, psychologists, psychotherapists, social workers and the respective patient, foster the exchange success and possible improvements of the treatment.

Group Type: ACTIVE_COMPARATOR

Yoga-based group intervention (YoGI)

Intervention Type: BEHAVIORAL

see above

Interventions

Yoga-based group intervention (YoGI)

see above

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Kerem Böge

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charité Universitätsmedizin Berlin, Campus Benjamin Franklin

Steglitz, State of Berlin, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Kerem Böge, Dr.

Role: CONTACT

Kerem.boege@charite.de

0049 30 450 517 789

Eric Hahn, Dr.

Role: CONTACT

Eric.hahn@charite.de

0049 30 450 517 547

Facility Contacts

Kerem Böge, Dr.

Role: primary

kerem.boege@charite.de

4930450517789

Other Identifiers

YING2021

Identifier Type: -

Identifier Source: org_study_id