Effect of a Mindfulness-Based Stress Reduction Program on Caregivers (MBSR-CG)

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

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.

Study Overview

• Status: Completed
• Conditions: Caregiver Stress in Chronic Mental Illness; Psychosocial Burden in Psychiatric Caregivers; Chronic Mental Illness Caregiving; Cognitive and Emotional Outcomes in Caregivers; Mental Illness Caregiver Support
• Intervention / Treatment: Behavioral: The Mindfulness-Based Stress Reduction program consists of structured mindfulness practices, psychoeducation, and experiential exercises delivered to caregivers.; Other: Usual Care Group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Söke
    • Aydin, Söke, Turkey (Türkiye), 09200
      • Söke Fehime Faik Kocagöz State Hospital Community Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: The Mindfulness-Based Stress Reduction program consists of structured mindfulness practices, psychoeducation, and experiential exercises delivered to caregivers.; The Mindfulness-Based Stress Reduction (MBSR) program is a structured behavioral intervention designed for primary caregivers of individuals with chronic mental illnesses. The program includes mindfulness practices, psychoeducation, and experiential exercises aimed at increasing present-moment awareness and adaptive coping skills. Sessions are delivered in a group format according to a standardized program structure.; Other: Usual Care Group; Usual care consists of standard support and services routinely provided by the community mental health center.; Other Names: Standard Care
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Control and Flexibility Questionnaire (CCFQ)	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.	Baseline, immediately post-intervention, and 3-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological Well-Being Scale (PWBS)	Psychological well-being is assessed using the Psychological Well-Being Scale (PWB Scale), a self-report instrument that measures multiple dimensions of well-being, including autonomy, personal growth, purpose in life, self-acceptance, environmental mastery, and positive relations with others. The scale consists of 42 items rated on a 6-point Likert scale, yielding a total score ranging from 42 to 252, with higher scores indicating greater psychological well-being.	Baseline, immediately post-intervention, and 3-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Compassion Scale - Short Form (SCS-SF)	Self-compassion is assessed using the Self-Compassion Scale-Short Form (SCS-SF), a self-report instrument designed to measure individuals' self-kindness, common humanity, and mindfulness in response to personal difficulties. The scale consists of 12 items rated on a 5-point Likert scale, yielding a total score ranging from 12 to 60, with higher scores indicating greater levels of self-compassion.	Baseline, immediately post-intervention, and 3-month follow-up

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University

Publications and helpful links

Helpful Links

• No external links are available at this time.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Actual): November 11, 2024
• Study Completion (Actual): November 15, 2024

Study Registration Dates

• First Submitted: July 4, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: MBSR-Caregivers-2025; PhD-Thesis-2025 (Other Identifier: Aydın Adnan Menderes University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The anonymized individual participant data (IPD) that underlie the results reported in this study, including demographic characteristics, outcome measures, and group assignment, will be shared with qualified researchers upon reasonable request. Personal identifiers will be removed to ensure confidentiality and compliance with ethical standards.
• IPD Sharing Time Frame: IPD and supporting documents will be available beginning 6 months after publication of the study results and will remain accessible for a period of 5 years. Researchers interested in accessing the data must submit a formal request and sign a data use agreement.
• IPD Sharing Access Criteria: Access to the anonymized IPD and supporting documents will be granted to academic researchers or institutions conducting non-commercial scientific studies. Requests should be made in writing to the corresponding author and must include a research proposal. Approved users will be required to sign a data-sharing agreement ensuring confidentiality and appropriate data use.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Study Data/Documents

1. Study Protocol
   Information comments: No external links to the study data are publicly available at this time. Data requests can be made by contacting the corresponding author or the Community Mental Health Center at Aydın Adnan Menderes University.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No