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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Germany
Charité Universitätsmedizin Berlin, Campus Benjamin Franklin
RECRUITING
Steglitz
Contact Information
Primary
Kerem Böge, Dr.
Kerem.boege@charite.de
0049 30 450 517 789
Backup
Eric Hahn, Dr.
Eric.hahn@charite.de
0049 30 450 517 547
Time Frame
Start Date: 2021-01-28
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 77
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Charite University, Berlin, Germany

This content was sourced from clinicaltrials.gov