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

NCT04730518 | Recruiting

• 1 other identifier: YING2021
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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).

Conditions

Psychotic Disorders

Outcome Measures

Primary Outcomes (3)

• PANSS Symptomatology - Positive and Negative Symptoms

  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)

  18 months

• Proportion of pp receiving threshold dose (Acceptability)

  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)

  18 months

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

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

  18 months

Secondary Outcomes (8)

• SMQ Mindfulness

  18 months

• BMQ Body Mindfulness

  18 months

• DASS Symptoms - Depression and Anxiety

  18 months

• PSP Personal and Social Performance

  18 months

• CFQ Cognitive Fusion

  18 months

Study Arms (2)

Yoga-based Group Intervention (YoGI)

EXPERIMENTAL

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.

Behavioral: Yoga-based group intervention (YoGI)

Treatment as usual (TAU)

ACTIVE COMPARATOR

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.

Behavioral: Yoga-based group intervention (YoGI)

Interventions

Yoga-based group intervention (YoGI) BEHAVIORAL

see above

Treatment as usual (TAU); Yoga-based Group Intervention (YoGI)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Universitätsmedizin Berlin, Campus Benjamin Franklin

Steglitz, State of Berlin, 1220, Germany

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Kerem Böge, Dr.

CONTACT

0049 30 450 517 789; Kerem.boege@charite.de

Eric Hahn, Dr.

CONTACT

0049 30 450 517 547; Eric.hahn@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blinded psychologist or psychiatrist who works independently of the (co-) psychologist conducts the rater-questionnaires. Due to the psychotherapeutic nature of the study, information about the treatment allocation has to be shared with the co-psychologist and the participants. Randomization is conducted by the Random Group Generator (pubmed, 2018).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A rater-blinded randomized controlled trial with a parallel group design is used. The participants in the control group receive the usual treatment (TAU), while the experimental group receives yoga-based group intervention (YoGI) in addition to TAU.

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 29, 2021
• Study Start: January 28, 2021
• Primary Completion: July 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)