The Effect of Mindfulness-Based Stress Reduction Program

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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MBSR, Caregiver

Intervention / Treatment
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* Other: Mindfulness Based Stress Reduction Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, parallel, two-arm randomized controlled clinical trial Masking: Single (Participant)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBSR Intervention<br>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<br>* 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.<br>* Other names: MBSR;|
| No Intervention: Control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety will be evaluated using the State-Trait Anxiety Scale | 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. | 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. | 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. | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MBSR, Anxiety, Hopelessness, Care burden, Nursing