The Effect of Mindfulness-Based Stress Reduction Program

NCT ID: NCT05245305

Last Updated: 2022-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-02-28

Brief Summary

This randomized controlled study evaluate the effect of the Mindfulness-Based Stress Reduction Program on the state-trait anxiety, hopelessness, self-compassion and care burden of the families of psychotic patients. The hypothesis of this study is that the Mindfulness-Based Stress Reduction Program improves the state-trait anxiety, hopelessness, self-compassion and care burden of the families of psychotic patients.

Detailed Description

Introduction: One of the chronic mental diseases, psychosis causes social and economic losses by negatively affecting the patient's feelings, thoughts and behaviors, interpersonal relations, work and social harmony, and the patient and family may experience different difficulties. With the transition to the community-based model in the provision of mental health services, the relatives of the patients have become the primary caregivers in the care of the patient and their responsibilities have increased even more.When the family is considered as a system, there is a constant interaction between the parts of the system and the change in the patient in case of illness can affect the whole family.When the disease occurs, one of the family members has to take care of the sick individual and caregivers experience emotional (decreased self-esteem, restlessness, depression, insomnia, social isolation, etc.), social (restriction of entertaining, relaxing and leisure time activities, reduction in the role of self-care, etc.). ) and economically (expenses not covered by social security creating an additional burden, reducing working hours, etc.). It is emphasized that psychosocial interventions for families increase the perception of social support, self-efficacy and satisfaction with treatment among caregivers, and reduce the perceived burden and recurrence of the disease.However, the high level of emotional expression and perceived stress of the families may trigger the recurrence of the disease. For this reason, family is naturally emphasized as an important factor in the recovery of the individual with a psychotic illness. Therefore, rehabilitation processes should be aimed not only at patients, but also towards caregivers. One of the interventions used for this purpose today is the Mindfulness-Based Stress Reduction (MBSR) program, which is an evidence-based intervention that teaches skills to reduce stress and manage challenging emotions in a group setting. Although the MBSR intervention is usually aimed at people with chronic physical and mental illnesses, the purpose of the intervention is not to replace medical treatment, but can be used as a supplement, supportive, preventive, complementary or simply a stand-alone method to heal patients. In this respect, it is thought that it is important for psychiatric nurses to use the MBSR program, which is a complementary, supportive, preventive and protective program, in the protection and strengthening of mental health in family members who care for psychosis patients. When the literature is examined, it is emphasized that the MBSR program has positive effects on caregiver family members. In this context, this study is planned to determine the effect of the Mindfulness-Based Stress Reduction Program on the state-trait anxiety, hopelessness, self-compassion and care burden of the families of psychotic patients.

Methods: In the study, 60 family members caring for an individual with psychotic illness were randomly assigned to the study and control groups. 11-week MBSR program will be apply to study group (n = 28). No intervention will be made to the control group (n = 28). The primary outcome of the study is the effect of MBSR on the state-trait anxiety, hopelessness, and self-compassion levels of caregiver family members. The secondary outcome of the study is the effect of MBSR on the caregiving burden of family members. Data will be collected pre-intervention, post-intervention, 3 and 6 months after the intervention.

Conditions

MBSR; Caregiver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

MBSR Intervention

The intervention group will take part in mindfulness-based stress reduction (MBSR) program led by a certified MBSR instructor via Zoom. The MBSR program was structured as 11 weeks, taking into account the characteristics of the participants.

Group Type: EXPERIMENTAL

Mindfulness Based Stress Reduction Program

Intervention Type: OTHER

The intervention was structured as 11 weeks, taking into account the group. The program takes 2-2.5 hours per week. The program includes raisin exercise, body scanning meditation, breath awareness meditation, sitting meditation, mindfull movement, walking meditation, vision meditation, compassion meditation,mindfulness communication and day of silence.

Control

No intervention was applied to the control group. Data will be collected from the control group simultaneously with the study group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness Based Stress Reduction Program

The intervention was structured as 11 weeks, taking into account the group. The program takes 2-2.5 hours per week. The program includes raisin exercise, body scanning meditation, breath awareness meditation, sitting meditation, mindfull movement, walking meditation, vision meditation, compassion meditation,mindfulness communication and day of silence.

Intervention Type: OTHER

Other Intervention Names

MBSR

Eligibility Criteria

Inclusion Criteria

• Above 18 years old
• Able to read and understand Turkish
• Taking care of the sick individual at home
• Living in the same house with the sick individual
• No psychiatric illness
• No problems with movement, sight, hearing or understanding
• Volunteer to participate in the study
• Able to access the internet with their phone or computer
• Those who did not receive any other psychological therapy during their working dates
• No previous meditation experience
• Having no practice in daily mind-body practices

Exclusion Criteria

• Under 18 years old
• Can't read and understand Turkish
• Any psychiatric illness receiving another psychological therapy on working dates
• Meditation experience before the study; having practice in daily mind-body practices
• Having problems with movement, vision, hearing, understanding
• Not willing to participate in the study
• Participants who participated in more than 50% of a mindfulness-based intervention prior to the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mersin University

OTHER

Sponsor Role: lead

Responsible Party

Munevver Bogahan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Münevver Boğahan, Assistant

Role: PRINCIPAL_INVESTIGATOR

Mersin University

Locations

Mersin University

Mersin, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Münevver Boğahan, Assistant

Role: CONTACT

munevverbghn@hotmail.com

+90 324 361 00 01 / 14238

Münevver Münevver, Assistant

Role: CONTACT

munevverbghn@hotmail.com

+90 324 361 00 01 / 14238

Facility Contacts

Münevver Boğahan, Research assistant

Role: primary

munevverbghn@hotmail.com

+90 324 361 00 01 / 14238

References

Caqueo-Urizar A, Miranda-Castillo C, Lemos Giraldez S, Lee Maturana SL, Ramirez Perez M, Mascayano Tapia F. An updated review on burden on caregivers of schizophrenia patients. Psicothema. 2014 May;26(2):235-43. doi: 10.7334/psicothema2013.86.

Reference Type: BACKGROUND

PMID: 24755026 (View on PubMed)

Liu Z, Chen QL, Sun YY. Mindfulness training for psychological stress in family caregivers of persons with dementia: a systematic review and meta-analysis of randomized controlled trials. Clin Interv Aging. 2017 Sep 22;12:1521-1529. doi: 10.2147/CIA.S146213. eCollection 2017.

Reference Type: BACKGROUND

PMID: 29026290 (View on PubMed)

Smith JM, Bright KS, Mader J, Smith J, Afzal AR, Patterson C, Dimitropolous G, Crowder R. A pilot of a mindfulness based stress reduction intervention for female caregivers of youth who are experiencing substance use disorders. Addict Behav. 2020 Apr;103:106223. doi: 10.1016/j.addbeh.2019.106223. Epub 2019 Nov 30.

Reference Type: BACKGROUND

PMID: 31838440 (View on PubMed)

Stjernsward S, Hansson L. Outcome of a web-based mindfulness intervention for families living with mental illness - A feasibility study. Inform Health Soc Care. 2017 Jan;42(1):97-108. doi: 10.1080/17538157.2016.1177533. Epub 2016 May 31.

Reference Type: BACKGROUND

PMID: 27245198 (View on PubMed)

Williams H, Simmons LA, Tanabe P. Mindfulness-Based Stress Reduction in Advanced Nursing Practice: A Nonpharmacologic Approach to Health Promotion, Chronic Disease Management, and Symptom Control. J Holist Nurs. 2015 Sep;33(3):247-59. doi: 10.1177/0898010115569349. Epub 2015 Feb 11.

Reference Type: BACKGROUND

PMID: 25673578 (View on PubMed)

Whitebird RR, Kreitzer M, Crain AL, Lewis BA, Hanson LR, Enstad CJ. Mindfulness-based stress reduction for family caregivers: a randomized controlled trial. Gerontologist. 2013 Aug;53(4):676-86. doi: 10.1093/geront/gns126. Epub 2012 Oct 15.

Reference Type: BACKGROUND

PMID: 23070934 (View on PubMed)

Bogahan M, Yilmaz S, Yilmaz M. Effects of Mindfulness-Based Stress Reduction Program on the Mental Health and Care Burden in Family Caregivers of Individuals with Psychosis. Community Ment Health J. 2025 Oct 17. doi: 10.1007/s10597-025-01527-z. Online ahead of print.

Reference Type: DERIVED

PMID: 41105316 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/24755026/

An updated review on burden on caregivers of schizophrenia patients

https://pubmed.ncbi.nlm.nih.gov/29026290/

Mindfulness training for psychological stress in family caregivers of persons with dementia: a systematic review and meta-analysis of randomized controlled trials

https://pubmed.ncbi.nlm.nih.gov/31838440/

A pilot of a mindfulness based stress reduction intervention for female caregivers of youth who are experiencing substance use disorders

https://pubmed.ncbi.nlm.nih.gov/27245198/

Outcome of a web-based mindfulness intervention for families living with mental illness - A feasibility study

https://pubmed.ncbi.nlm.nih.gov/25673578/

Mindfulness-Based Stress Reduction in Advanced Nursing Practice: A Nonpharmacologic Approach to Health Promotion, Chronic Disease Management, and Symptom Control

https://pubmed.ncbi.nlm.nih.gov/23070934/

Mindfulness-based stress reduction for family caregivers: a randomized controlled trial

Other Identifiers

Münevver Boğahan

Identifier Type: REGISTRY

Identifier Source: secondary_id

munevverbghn

Identifier Type: -

Identifier Source: org_study_id