- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07497516
Mindfulness-Based Yoga in Schizophrenia (MBY-SCZ)
The Effect of Mindfulness-Based Yoga on Psychological Well-Being and Happiness in Individuals With Schizophrenia: A Randomized Controlled Trial
This randomized controlled trial aimed to evaluate the effect of mindfulness-based yoga on psychological well-being and happiness in individuals diagnosed with schizophrenia. Participants were recruited from community mental health centers and randomly assigned to either an intervention group or a control group.
The intervention group participated in a structured mindfulness-based yoga program consisting of 12 sessions over six weeks, including mindfulness practices, breathing exercises, meditation, and yoga postures. The control group received routine care without additional intervention.
Primary outcomes included psychological well-being and happiness, measured using validated scales at baseline and post-intervention. The findings of the study are expected to contribute to the development of psychosocial interventions that support mental health and well-being in individuals with schizophrenia.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tarsus
-
Mersin, Tarsus, Turkey (Türkiye), 33400
- Tarsus University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with schizophrenia according to DSM-5 criteria
Aged between 18 and 65 years
- Willing to participate in the study
- Able to provide informed consent
Exclusion Criteria:
- Being in an acute exacerbation phase of schizophrenia
- Participation in mindfulness or yoga training within the last 6 months
- Presence of comorbid neurological or cognitive disorders (e.g., dementia, delirium, intellectual disability, or history of head trauma)
- Current substance use
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mindfulness-Based Yoga
Participants receive a structured mindfulness-based yoga program consisting of 12 sessions over 6 weeks.
|
A structured mindfulness-based yoga program consisting of 12 sessions delivered over 6 weeks.
The program includes mindfulness practices, breathing exercises, meditation, and yoga postures conducted in group sessions.
|
|
No Intervention: Routine Care
Participants receive routine care without additional intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological Well-Being
Time Frame: Baseline and 6 weeks (post-intervention)
|
Psychological well-being will be assessed using the Psychological Well-Being Scale (PWB), a validated self-report instrument consisting of 8 items rated on a 7-point Likert scale.
Higher scores indicate greater psychological well-being.
|
Baseline and 6 weeks (post-intervention)
|
|
Happiness
Time Frame: Baseline and 6 weeks (post-intervention)
|
Happiness will be assessed using the Oxford Happiness Questionnaire Short Form (OHQ-SF), a validated self-report scale.
Higher scores indicate greater levels of happiness.
|
Baseline and 6 weeks (post-intervention)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- MBY-SCZ-RCT-2024
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.
Clinical Trials on SCHIZOPHRENIA 1 (Disorder)
-
New York State Psychiatric InstituteBristol-Myers SquibbNot yet recruitingSchizoaffecitve Disorder | SCHIZOPHRENIA 1 (Disorder)United States
-
University of California, San DiegoNot yet recruitingSchizoaffecitve Disorder | SCHIZOPHRENIA 1 (Disorder)
-
Shanghai Mental Health CenterRecruiting
-
Jiangsu Hansoh Pharmaceutical Co., Ltd.CompletedSCHIZOPHRENIA 1 (Disorder)China
-
The Hashemite UniversityNot yet recruitingSCHIZOPHRENIA 1 (Disorder) | Hospitalized Adult Patients
-
Azienda Sanitaria Locale Napoli 3 Sud, UOCSM Torre...Active, not recruitingSchizoaffective Disorder | SCHIZOPHRENIA 1 (Disorder)Italy
-
Vanderbilt University Medical CenterBeth Israel Deaconess Medical CenterCompletedSCHIZOPHRENIA 1 (Disorder) | Nicotine UseUnited States
-
University of Alabama at BirminghamNot yet recruitingPsychosis | Schizophrenia Prodromal | SCHIZOPHRENIA 1 (Disorder)United States
-
Nathan Kline Institute for Psychiatric ResearchNational Institute of Mental Health (NIMH); Columbia University; Research Foundation...RecruitingSchizo Affective Disorder | SCHIZOPHRENIA 1 (Disorder)United States
-
Nikolai AlbertRecruitingSchizotypal Disorder | SCHIZOPHRENIA 1 (Disorder) | Post Traumatic Stress SymptomsDenmark
Clinical Trials on Mindfulness-Based Yoga
-
Ebru DurusoyActive, not recruiting
-
Elizabethtown CollegeNot yet recruitingImpulsive Behavior | Prosocial Behavior | Self RegulationUnited States
-
Jeanmarie R. Burke, PhDCompleted
-
Holland Bloorview Kids Rehabilitation HospitalCanadian Institutes of Health Research (CIHR)CompletedBrain Concussion | Mild Traumatic Brain InjuryCanada
-
University of Wisconsin, MadisonThe Dana FoundationTerminated
-
The Hong Kong Polytechnic UniversityRecruiting
-
Georgia State UniversityNew York University; Kaiser Foundation Research Institute; UConn HealthCompleted
-
Trakya UniversityActive, not recruitingPrenatal Yoga | Mindfulness-Based Childbirth | Parenting CounselingTurkey (Türkiye)
-
Universität Duisburg-EssenEden StiftungCompleted
-
Kutahya Health Sciences UniversityKoç UniversityCompleted