Yoga-based Group Therapy for In-patients With Schizophrenia Spectrum Disorders

Psychotic Disorders Clinical Trial

— YING  

Official title:

Yoga-based Group Therapy for In-Patients With Schizophrenia Spectrum Disorder - Feasibility, Acceptability, and Preliminary Outcomes of a Rater-Blinded Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04730518
• Other study ID #: YING2021
• Status: Recruiting
• Phase: N/A
• Start date: January 28, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2023
• Source: Charite University, Berlin, Germany
• Contact: Kerem Böge, Dr.
• Phone: 0049 30 450 517 789
• Email: Kerem.boege[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A rater-blinded randomized controlled trial with a parallel-group design is utilized, comprised of yoga-based group therapy (YBGT) in the experimental condition, and treatment as usual (TAU) in the control condition. The participants in the experimental condition participate in YBGT 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 YBGT (T0), and after four weeks of taking part in intervention (T1).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• male and female participants
• treated as psychiatric inpatients at the psychosis - or social-psychiatric day ward
• between 18 and 65 years of age
• 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

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

Behavioral:
• Yoga-based group therapy
see above

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin, Campus Benjamin Franklin	Berlin-Steglitz	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Nr. of pp willing to participate in YBGT (Operational Feasibility)	The number of eligible participants that are willing to participate in YBGT (recruitment)	18 months
Secondary	SMQ Mindfulness	Southampton mindfulness questionnaire (SMQ), 16 items on a scale from 1 (applies fully) to 7 (does not apply at all)	18 months
Secondary	BMQ Body Mindfulness	Body Mindfulness Questionnaire (BMQ), 14 items on a scale from 1 (not at all) to (5) every day	18 months
Secondary	PANSS Symptomatology - Positive and Negative Symptoms	Positive and Negative Syndrome Scale (PANSS) to assess symptoms on a scale from 1 (non-existent) to 7 (extremely severe, 14 questions)	18 months
Secondary	DASS Symptoms - Depression and Anxiety	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)	18 months
Secondary	PSP Personal and Social Performance	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.	18 months
Secondary	CFQ Cognitive Fusion	Cognitive Fusion Questionnaire (CFQ), 7 questions that can be answered on a scale from 1(not applicable) to 7 (applies always)	18 months
Secondary	WHO-QOL-Bref Quality of Life - domains assessed include physical and psychological health, social relationships and environment	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.	18 months
Secondary	CANTAB Broad Cognitive Functioning	CANTAB mobile App to assess cognitive functioning, validated version for schizophrenia	18 months
Secondary	SSTICS Subjective Cognitive Functioning	Subjective Scale to Investigate Cognition (SSTICS), 21 items from a scale from 1 to 5.	18 months