NCT07497516

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 23, 2026

Last Update Submit

March 23, 2026

Conditions

Keywords

Schizophrenia Mindfulness Yoga Mindfulness-Based Yoga Psychological Well-Being Happiness Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

  • Psychological Well-Being

    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

    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)

Study Arms (2)

Mindfulness-Based Yoga

EXPERIMENTAL

Participants receive a structured mindfulness-based yoga program consisting of 12 sessions over 6 weeks.

Behavioral: Mindfulness-Based Yoga

Routine Care

NO INTERVENTION

Participants receive routine care without additional intervention.

Interventions

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.

Mindfulness-Based Yoga

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarsus University

Mersin, Tarsus, 33400, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tarsus university

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 27, 2026

Study Start

February 1, 2024

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations