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临床试验/NCT07076940
NCT07076940已完成不适用

The Effect of Mindfulness-Based Education on Stress Perception and Well-Being in Caregivers of Individuals Diagnosis With Schizophrenia

Halic University1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2022年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
1
主要终点
Perceived Stress Scale

研究概览

简要总结

The research is carried out by PhD student Azize Gözde Atakoğlu under the supervision of Associate Professor Gülcan Kendirkıran.

This study was conducted with a randomized control group, experimental research design in order to determine the effects of mindfulness-based training on stress perception and well-being in caregivers of individuals diagnosed with schizophrenia. The research data were collected at the Community Mental Health Center affiliated with a Training and Research Hospital in Istanbul between 15 September 2022 and 1 February 2023. Before commencing the study, an ethical approval decision was obtained from the Haliç University Non-Interventional Clinical Research Ethics Committee (May 25, 2022-90). Subsequently, an institutional permit for the study (June 28, 2022-637) was obtained from the Istanbul Provincial Health Directorate Bakırköy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital, along with the ethics committee approval. The sample of the study consisted of caregivers of individuals diagnosed with schizophrenia, 15 in the intervention group, 15 in the psychoeducation group, and 30 in the control group (n=60). The study data were collected using the Personal Information Form, Perceived Stress Scale (PSS), Psychological Well-Being Scale (PWS), Participant Experience Form (PEF), Post-Experience Stress Assessment Questionnaire (PSSQ), and Home Application Note Form. Frequency tables and descriptive statistics were used in the interpretation of the findings. For measurement values suitable for normal distribution, "ANOVA" test (F-table value), "Repeated Measures" test (F-table value), for measurement values not suitable for normal distribution, Kruskal-Wallis H" test (χ2-table value), "Friedman" test (χ2-table value) method was used. "Pearson-χ2" was used to examine the relationships between two qualitative variables, and "Spearman" correlation coefficient was used to examine the relationships between two quantitative variables not having normal distribution. As a result of this study, it was found that mindfulness-based intervention reduced stress in caregivers and contributed to psychological well-being (p<0.05). In addition, it was observed that the effect continued even though it decreased in follow-up tests. In this direction, it is recommended that follow-up tests be kept longer and intermediate interventions be added in other studies to be conducted. It is also recommended that qualitative studies be conducted on this subject in order to obtain detailed feedback on the processes related to the initiatives.

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

Participants were assigned to different groups. Intervention plans were made for each group on different days to minimize contact between groups.

入排标准

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

入选标准

  • •Being over 18 years of age
  • •The patient they are caring for must have been diagnosed with schizophrenia according to the DSM-V (Diagnostic and Statistical Manual of Mental Disorders) classification at least one year ago
  • •Living together in the same house for at least one year
  • •Being directly responsible for the patient's treatment arrangements and care
  • •Being open to communication and collaboration.

排除标准

  • •Having any condition that may prevent them from receiving education.
  • •Having a vision, hearing, or comprehension problem.

研究组 & 干预措施

Mindfulness Group

Experimental

The mindfulness-based training program was completed in a total of five sessions (one day per week, 60 minutes, for a total of five consecutive weeks).

干预措施: Mindfulness-based Training Program (Other)

Psychoeducation Group

Other

The "Psychoeducational Program," themed around stress, well-being, and mindfulness, was completed in two sessions (two sessions over five weeks, each lasting 60 minutes).

干预措施: Psychoeducational Program (Other)

Control Group

No Intervention

No intervention was administered.

结局指标

主要结局

Perceived Stress Scale

时间窗: Before the intervention, immediately after the intervention, and 1 month after the last measurement

The scale consists of 14 items in a 5-point Likert type. 7 items with positive expressions (4, 5, 6, 7, 9, 10, 13) are reverse coded and high scores indicate a high level of perceived stress. The scale has 2 sub-dimensions as "perception of inadequacy" and "perception of stress/discomfort." The score to be obtained from PSS-14 varies between 0 and 56. The Cronbach's Alpha coefficient of the Turkish scale was determined as 0.84 and its reliability as 0.87. Cronbach's Alpha values obtained in this study are as follows in the whole sample; inadequate self-efficacy perception is 0.89, stress discomfort perception is 0.79, PSS total is 0.89.

Psychological Well-Being Scale

时间窗: Before the intervention, immediately after the intervention, and 1 month after the last measurement

The items of PWB are answered on a scale of 1-7, from strongly disagree (1) to strongly agree (7). All items are expressed positively. Scores range from 8 (if strongly disagree is answered to all items) to 56 (if strongly agree is answered to all items). A high score indicates that the person has many psychological resources and strengths. Although the scale does not provide separate measurements of aspects of well-being, it provides an overview of positive functions in different areas that are believed to be important. The Cronbach's alpha internal consistency coefficient obtained in the reliability study of the scale was calculated as .80 (Telef, 2013). Cronbach's Alpha values obtained in this study; is 0.91 in the entire sample.

次要结局

  • Personal Information Form(Before the intervention)
  • Participant Experience Form(Immediately after the intervention)

研究者

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

Azize Gözde Atakoğlu

Principal Investigator, PhD Student

Halic University

研究点 (1)

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