Effect of a Mindfulness-Based Stress Reduction Program on Caregivers (NCT07322081) | Clinical Trial Compass
CompletedNot Applicable
Effect of a Mindfulness-Based Stress Reduction Program on Caregivers
Turkey (Türkiye)60 participantsStarted 2023-01-15
Plain-language summary
This study is designed to investigate the effects of a Mindfulness-Based Stress Reduction (MBSR) program on cognitive control and flexibility, psychological well-being, and self-compassion among primary caregivers of individuals with chronic mental illnesses. Caregivers of individuals with chronic mental health conditions are exposed to prolonged psychological, emotional, and cognitive demands, which may negatively affect their mental well-being and coping capacities.
The study adopts a mixed-methods approach using an exploratory sequential design in order to obtain a comprehensive understanding of caregivers' needs and experiences and to evaluate the potential impact of the intervention. Qualitative findings are intended to inform the development and structuring of the MBSR program, while the quantitative phase is designed to examine changes in key psychological outcomes following the intervention. The study aims to contribute to the growing body of evidence supporting mindfulness-based interventions for caregiver populations and to inform future mental health service practices.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Being the primary caregiver of an individual with a chronic mental illness who is registered at the Community Mental Health Center (CMHC) of Söke Fehime Faik Kocagöz State Hospital
* Residing in the Söke district of Aydın province
* Being literate
* Having been the primary caregiver of the patient for at least six months
Exclusion Criteria:
* Having been diagnosed with any psychiatric disorder
* Having an intellectual disability
* Data from caregivers who submitted incomplete data collection forms were excluded from the study
* Caregivers who chose to withdraw from the study during the research process were excluded, and any data obtained from them were not used in the analysis
* Individuals who missed more than two sessions of the Mindfulness-Based Stress Reduction Program were excluded, and their data were not included in the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cognitive Control and Flexibility Questionnaire (CCFQ)
Timeframe: Baseline, immediately post-intervention, and 3-month follow-up