search
Back to results

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

Primary Purpose

Psychotic Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Yoga-based group therapy
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité Universitätsmedizin Berlin, Campus Benjamin FranklinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Yoga-based Group Therapy

Treatment as usual (TAU)

Arm Description

The yoga-based group therapy (YBGT) 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 experienced in yoga-based therapy. 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.

Treatment as usual (TAU) at the ward consists of a variety of daily activity groups the patients can choose from. 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 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, psychotherapists, social workers and the respective patient, foster the exchange success and possible improvements of the treatment.

Outcomes

Primary Outcome Measures

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)
Nr. of pp willing to participate in YBGT (Operational Feasibility)
The number of eligible participants that are willing to participate in YBGT (recruitment)

Secondary Outcome Measures

SMQ Mindfulness
Southampton mindfulness questionnaire (SMQ), 16 items on a scale from 1 (applies fully) to 7 (does not apply at all)
BMQ Body Mindfulness
Body Mindfulness Questionnaire (BMQ), 14 items on a scale from 1 (not at all) to (5) every day
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)
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)
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.
CFQ Cognitive Fusion
Cognitive Fusion Questionnaire (CFQ), 7 questions that can be answered on a scale from 1(not applicable) to 7 (applies always)
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.
CANTAB Broad Cognitive Functioning
CANTAB mobile App to assess cognitive functioning, validated version for schizophrenia
SSTICS Subjective Cognitive Functioning
Subjective Scale to Investigate Cognition (SSTICS), 21 items from a scale from 1 to 5.

Full Information

First Posted
January 26, 2021
Last Updated
February 7, 2023
Sponsor
Charite University, Berlin, Germany
search

1. Study Identification

Unique Protocol Identification Number
NCT04730518
Brief Title
Yoga-based Group Therapy for In-patients With Schizophrenia Spectrum Disorders
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 28, 2021 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A rater-blinded randomized controlled trial with a parallel group design is used. The participants in the conditional group receive the usual treatment (TAU), while the experimental group receives yoga-based group therapy (YBGT) in addition to TAU.
Masking
Outcomes Assessor
Masking Description
A blinded psychologist 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).
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yoga-based Group Therapy
Arm Type
Experimental
Arm Description
The yoga-based group therapy (YBGT) 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 experienced in yoga-based therapy. 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.
Arm Title
Treatment as usual (TAU)
Arm Type
Active Comparator
Arm Description
Treatment as usual (TAU) at the ward consists of a variety of daily activity groups the patients can choose from. 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 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, psychotherapists, social workers and the respective patient, foster the exchange success and possible improvements of the treatment.
Intervention Type
Behavioral
Intervention Name(s)
Yoga-based group therapy
Intervention Description
see above
Primary Outcome Measure Information:
Title
Proportion of pp receiving threshold dose (Acceptability)
Description
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)
Time Frame
18 months
Title
Nr. of pp willing to participate in YBGT (Operational Feasibility)
Description
The number of eligible participants that are willing to participate in YBGT (recruitment)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
SMQ Mindfulness
Description
Southampton mindfulness questionnaire (SMQ), 16 items on a scale from 1 (applies fully) to 7 (does not apply at all)
Time Frame
18 months
Title
BMQ Body Mindfulness
Description
Body Mindfulness Questionnaire (BMQ), 14 items on a scale from 1 (not at all) to (5) every day
Time Frame
18 months
Title
PANSS Symptomatology - Positive and Negative Symptoms
Description
Positive and Negative Syndrome Scale (PANSS) to assess symptoms on a scale from 1 (non-existent) to 7 (extremely severe, 14 questions)
Time Frame
18 months
Title
DASS Symptoms - Depression and Anxiety
Description
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)
Time Frame
18 months
Title
PSP Personal and Social Performance
Description
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.
Time Frame
18 months
Title
CFQ Cognitive Fusion
Description
Cognitive Fusion Questionnaire (CFQ), 7 questions that can be answered on a scale from 1(not applicable) to 7 (applies always)
Time Frame
18 months
Title
WHO-QOL-Bref Quality of Life - domains assessed include physical and psychological health, social relationships and environment
Description
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.
Time Frame
18 months
Title
CANTAB Broad Cognitive Functioning
Description
CANTAB mobile App to assess cognitive functioning, validated version for schizophrenia
Time Frame
18 months
Title
SSTICS Subjective Cognitive Functioning
Description
Subjective Scale to Investigate Cognition (SSTICS), 21 items from a scale from 1 to 5.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kerem Böge, Dr.
Phone
0049 30 450 517 789
Email
Kerem.boege@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Hahn, Dr.
Phone
0049 30 450 517 547
Email
Eric.hahn@charite.de
Facility Information:
Facility Name
Charité Universitätsmedizin Berlin, Campus Benjamin Franklin
City
Berlin-Steglitz
State/Province
Berlin
ZIP/Postal Code
1220
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerem Böge, Dr.
Phone
4930450517789
Email
kerem.boege@charite.de

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs