The Effect of Mindfulness-Based Stress Reduction Program (Mindfulness)

February 8, 2022 updated by: Munevver Bogahan, Mersin University

The Effect of Mindfulness-Based Stress Reduction Program on Mental Status and Care Burden of Psychotic Patients' Families

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Mersin, Turkey, 33343
        • Mersin University
        • Contact:
        • Principal Investigator:
          • Serpil Türkleş, Associate professor
        • Principal Investigator:
          • Mualla Yılmaz, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Other Names:
  • MBSR
No Intervention: Control
No intervention was applied to the control group. Data will be collected from the control group simultaneously with the study group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety will be evaluated using the State-Trait Anxiety Scale
Time Frame: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
The total score obtained from both scales varies between 20 and 80. It states that 0-19 points mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help.
Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Care burden will be assessed using the Caregiver Burden Scale.
Time Frame: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
A score between 22 and 110 is taken from the scale. Obtained points; It is evaluated by grading as "light load" between 22-46, "medium load" between 47-55, "severe load" between 56-110.
Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
Hopelessness will be measured using the Beck Hopelessness Scale.
Time Frame: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
The score range of the scale is 0-20. When the scores obtained are high, hopelessness in the individual is considered high
Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
Self-compassion will be assessed using the Self-Compassion Scale.
Time Frame: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.

To calculate the total self-compassion score, the "self-judgmental", "social isolation" and "over-identification" subscale items are reverse coded.

Then, the self-compassion level is calculated by taking the average of all the items.

The higher the score for each sub-dimension, the higher the level of self-compassion.
Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
Focus Group Interview Questionnaire I
Time Frame: Within 1 week postintervention
Focus Group Interview Questionnaire I was created by the researcher in order to evaluate the experiences of the individuals in the study group regarding the MBSR program. There are five questions in the form.
Within 1 week postintervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mersin University

Investigators

  • Principal Investigator: Münevver Boğahan, Assistant, Mersin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

May 15, 2022

Study Completion (Anticipated)

February 28, 2023

Study Registration Dates

First Submitted

January 24, 2022

First Submitted That Met QC Criteria

February 8, 2022

First Posted (Actual)

February 17, 2022

Study Record Updates

Last Update Posted (Actual)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 8, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • munevverbghn
  • Münevver Boğahan (Registry Identifier: Münevver Boğahan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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