Effect of a Mindfulness-Based Stress Reduction Program on Caregivers

NCT07322081 | Completed DMC

• 2 other identifiers: MBSR-Caregivers-2025PhD-Thesis-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychosocial Burden in Psychiatric Caregivers; Chronic Mental Illness Caregiving; Cognitive and Emotional Outcomes in Caregivers; Mental Illness Caregiver Support; Caregiver Stress in Chronic Mental Illness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Psychological Well-Being Scale (PWBS)

  Baseline, immediately post-intervention, and 3-month follow-up

Other Outcomes (1)

• Self-Compassion Scale - Short Form (SCS-SF)

  Baseline, immediately post-intervention, and 3-month follow-up

Study Arms (2)

Mindfulness-Based Stress Reduction Program

EXPERIMENTAL

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.; Other: Usual Care Group

Control Group (Usual Care)

NO INTERVENTION

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.

Interventions

Usual Care Group OTHER

Usual care consists of standard support and services routinely provided by the community mental health center.

Also known as: Standard Care

Mindfulness-Based Stress Reduction Program

The Mindfulness-Based Stress Reduction program consists of structured mindfulness practices, psychoeducation, and experiential exercises delivered to caregivers. BEHAVIORAL

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.

Mindfulness-Based Stress Reduction Program

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Söke Fehime Faik Kocagöz State Hospital Community Mental Health Center

Aydin, Söke, 09200, Turkey (Türkiye)

Location

Related Links

• No external links are available at this time.

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the behavioral intervention, masking of participants and care providers is not feasible.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student in Psychiatric Nursing

Model Details: This study is designed as a randomized controlled trial with a parallel assignment model. Eligible participants are planned to be randomly assigned to either an intervention group receiving the Mindfulness-Based Stress Reduction program or a control group receiving usual care throughout the study period.

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: January 7, 2026
• Study Start: January 15, 2023
• Primary Completion: November 11, 2024
• Study Completion: November 15, 2024
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

TU (1)