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临床试验/NCT05245305
NCT05245305Unknown不适用

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

Mersin University2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
56
试验地点
2
主要终点
Anxiety will be evaluated using the State-Trait Anxiety Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

56 caregiver family members who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental and control groups by simple randomization by an independent researcher who is not included in the study. After the assignments, the statistician will put the 56 family members in which group in sealed envelopes and hand them over to the researcher. The researcher and participants will not know the intervention and control groups until they open the envelope at this stage (single blinding).

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Anxiety will be evaluated using the State-Trait Anxiety Scale

时间窗: 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.

次要结局

  • Care burden will be assessed using the Caregiver Burden Scale.(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.(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.(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(Within 1 week postintervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Munevver Bogahan

Principal Investigator

Mersin University

研究点 (2)

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