Trials / Completed

CompletedNCT07322081

Effect of a Mindfulness-Based Stress Reduction Program on Caregivers

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

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 60 (actual)

Sponsor: Aydin Adnan Menderes University · Academic / Other
Sex: All
Age: 18 Years – 60 Years
Healthy volunteers: Accepted

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.

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.

Conditions

Interventions

Type	Name	Description
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.

Timeline

Start date: 2023-01-15
Primary completion: 2024-11-11
Completion: 2024-11-15
First posted: 2026-01-07
Last updated: 2026-01-23

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07322081. Inclusion in this directory is not an endorsement.