Effect of a Mindfulness-Based Stress Reduction Program for Caregivers of Individuals With Chronic Mental Illness on Cognitive Control and Flexibility , Psychological Well-Being and Self-Compassion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cognitive Control and Flexibility Questionnaire (CCFQ)
研究概览
简要总结
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.
详细描述
The primary objective of this study is to evaluate the effects of a Mindfulness-Based Stress Reduction (MBSR) program on cognitive control and flexibility, psychological well-being, and self-compassion in primary caregivers of individuals with chronic mental illnesses receiving services from a community mental health center. Caregiving for individuals with chronic mental health conditions often involves sustained emotional, cognitive, and social demands, which may increase vulnerability to psychological distress and reduce adaptive coping capacities.
The study is designed as a mixed-methods research utilizing an exploratory sequential design, integrating qualitative and quantitative research components. In the initial qualitative phase, in-depth, face-to-face interviews are planned to explore caregivers' experiences, perceived challenges, coping strategies, and expectations related to caregiving and psychological support. The qualitative findings are intended to guide the development, adaptation, and content refinement of the MBSR intervention in accordance with the specific needs of the caregiver population.
Following the qualitative phase, the quantitative component of the study is designed as a randomized controlled experimental trial. Eligible caregivers are planned to be randomly assigned to either an intervention group receiving the MBSR program or a control group receiving routine services. The MBSR program is structured to include mindfulness practices, psychoeducation, and experiential exercises aimed at enhancing present-moment awareness, emotional regulation, cognitive flexibility, and self-compassion.
Standardized self-report instruments are planned to be used to assess cognitive control and flexibility, psychological well-being, and self-compassion at predefined assessment points. The quantitative findings are intended to complement the qualitative results and to provide a systematic evaluation of the potential effects of the MBSR program.
The integration of qualitative and quantitative findings is expected to provide a comprehensive understanding of the intervention process and outcomes, supporting the development of evidence-based psychosocial interventions for caregivers of individuals with chronic mental illnesses within community mental health service settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Due to the nature of the behavioral intervention, masking of participants and care providers is not feasible.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Mindfulness-Based Stress Reduction Program
Participants assigned to this arm receive the Mindfulness-Based Stress Reduction (MBSR) program designed for primary caregivers of individuals with chronic mental illnesses, in addition to routine services provided by the community mental health center.
干预措施: The Mindfulness-Based Stress Reduction program consists of structured mindfulness practices, psychoeducation, and experiential exercises delivered to caregivers. (Behavioral)
Mindfulness-Based Stress Reduction Program
Participants assigned to this arm receive the Mindfulness-Based Stress Reduction (MBSR) program designed for primary caregivers of individuals with chronic mental illnesses, in addition to routine services provided by the community mental health center.
干预措施: Usual Care Group (Other)
Control Group (Usual Care)
Participants assigned to this arm receive routine care and standard support services provided by the community mental health center and do not receive the Mindfulness-Based Stress Reduction program.
结局指标
主要结局
Cognitive Control and Flexibility Questionnaire (CCFQ)
时间窗: Baseline, immediately post-intervention, and 3-month follow-up
Cognitive Control and Flexibility (Cognitive Control and Flexibility Questionnaire) Outcome Measure Description: Cognitive control and flexibility are assessed using the Cognitive Control and Flexibility Questionnaire (CCFQ), a self-report scale designed to evaluate caregivers' perceived ability to regulate thoughts and behaviors and to adapt flexibly to changing environmental demands. The total score ranges from 18 to 126, with higher scores indicating greater cognitive control and flexibility.
次要结局
- Psychological Well-Being Scale (PWBS)(Baseline, immediately post-intervention, and 3-month follow-up)
研究者
Ömer USLU
PhD Student in Psychiatric Nursing
Aydin Adnan Menderes University