- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04730518
Yoga-based Group Therapy for In-patients With Schizophrenia Spectrum Disorders (YING)
Yoga-based Group Therapy for In-Patients With Schizophrenia Spectrum Disorder - Feasibility, Acceptability, and Preliminary Outcomes of a Rater-Blinded Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kerem Böge, Dr.
- Phone Number: 0049 30 450 517 789
- Email: Kerem.boege@charite.de
Study Contact Backup
- Name: Eric Hahn, Dr.
- Phone Number: 0049 30 450 517 547
- Email: Eric.hahn@charite.de
Study Locations
-
-
Berlin
-
Berlin-Steglitz, Berlin, Germany, 1220
- Recruiting
- Charité Universitätsmedizin Berlin, Campus Benjamin Franklin
-
Contact:
- Kerem Böge, Dr.
- Phone Number: 4930450517789
- Email: kerem.boege@charite.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Yoga-based Group Therapy
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. |
see above
|
ACTIVE_COMPARATOR: Treatment as usual (TAU)
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.
|
see above
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of pp receiving threshold dose (Acceptability)
Time Frame: 18 months
|
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 YBGT (Operational Feasibility)
Time Frame: 18 months
|
The number of eligible participants that are willing to participate in YBGT (recruitment)
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SMQ Mindfulness
Time Frame: 18 months
|
Southampton mindfulness questionnaire (SMQ), 16 items on a scale from 1 (applies fully) to 7 (does not apply at all)
|
18 months
|
BMQ Body Mindfulness
Time Frame: 18 months
|
Body Mindfulness Questionnaire (BMQ), 14 items on a scale from 1 (not at all) to (5) every day
|
18 months
|
PANSS Symptomatology - Positive and Negative Symptoms
Time Frame: 18 months
|
Positive and Negative Syndrome Scale (PANSS) to assess symptoms on a scale from 1 (non-existent) to 7 (extremely severe, 14 questions)
|
18 months
|
DASS Symptoms - Depression and Anxiety
Time Frame: 18 months
|
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
|
PSP Personal and Social Performance
Time Frame: 18 months
|
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
|
CFQ Cognitive Fusion
Time Frame: 18 months
|
Cognitive Fusion Questionnaire (CFQ), 7 questions that can be answered on a scale from 1(not applicable) to 7 (applies always)
|
18 months
|
WHO-QOL-Bref Quality of Life - domains assessed include physical and psychological health, social relationships and environment
Time Frame: 18 months
|
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
|
CANTAB Broad Cognitive Functioning
Time Frame: 18 months
|
CANTAB mobile App to assess cognitive functioning, validated version for schizophrenia
|
18 months
|
SSTICS Subjective Cognitive Functioning
Time Frame: 18 months
|
Subjective Scale to Investigate Cognition (SSTICS), 21 items from a scale from 1 to 5.
|
18 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YING2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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