The Effects of Mindfulness and Web-Based Physical Activity Program on Mental and Cardiovascular Risk in Patients with Schizophrenia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mental Well-Being total mean score
研究概览
简要总结
This study was aimed to examine the effects of the Mindfulness and Web-Based Physical Activity Program - consisting of two weeks of mindfulness skills followed by 12 weeks of walking and exercise - delivered through videos uploaded to a YouTube channel on mental and cardiovascular risk in patients with schizophrenia. The main questions it aims to answer are:
After the Mindfulness and Web-Based Physical Activity Program, H1-1: There is a statistically significant difference in the mean total scores of mental well-being between the intervention and control groups.
H1-2: There is a statistically significant difference in the mean total scores of sleep quality between the intervention and control groups.
H1-3: There is a statistically significant difference in the mean total scores of the subscales of the Coping Style Scale (self-confident approach, optimistic approach, helpless approach, submissive approach, and seeking of social support) between the intervention and control groups.
H1-4: There is a statistically significant difference in terms of cardiovascular risk levels between the intervention and control groups.
Researchers were compared the Mindfulness and Web-Based Physical Activity Program to a control group (no intervention) to see if the Mindfulness and Web-Based Physical Activity Program works on mental and cardiovascular risk in patients with schizophrenia.
Participants were:
- followed in the first phase of the Mindfulness and Web-Based Physical Activity Program, the "Mindfulness Skill Development Program", which included activities for individuals to develop their mindfulness skills, five days a week for two weeks from October 23 to November 3, 2023 through videos uploaded on the YouTube channel.
- followed in the second phase of the Mindfulness and Web-Based Physical Activity Program, the 12-week "Mindful Physical Activity Program", which consisted of "Mindful Walking" and "Mindful Physical Activity Day" sessions held twice a week (Tuesday and Thursday) and three days a week for 50 minutes from November 2023 to January 2024 through videos uploaded on the YouTube channel.
详细描述
The study included 110 individuals aged 25-55 who were diagnosed with schizophrenia and applied to the S.U. Faculty of Medicine Mental Health and Diseases Polyclinic in the last year, and were examined according to the inclusion-exclusion criteria. A total of 50 individuals were included in the study. These individuals were randomly assigned to two groups: intervention and control. Pre-test data were collected using the "Personal Information Form", "Mental Well-Being Scale", "Pittsburgh Sleep Quality Index (PSQI)", "Coping Style Scale", and "QRISK3 Index" from the intervention and control groups by researchers between October 2023 and January 2024 in the Group Therapy Room of the Mental Health and Diseases Polyclinic, based on self-reporting. The "Mindfulness and Web-Based Physical Activity Program" was completed in a total of 14 weeks, consisting of a 2-week "Mindfulness Skill Development Program" and a 12-week "Mindful Physical Activity Program" to intervention group through videos uploaded on the YouTube channel opened via the web. Before starting the Mindful Physical Activity Program, all participants in the intervention group were provided with sports shoes, resistance bands, exercise mats, and pedometers to encourage regular participation in physical activity. Additionally, the researchers gave participants the Mindful Physical Activity Program Follow-up Form and the Mindful Walking Follow-up Form to track their daily involvement in the program. At the end of the Mindfulness and Web-Based Physical Activity Program, both the intervention and control groups were administered the "Mental Well-Being Scale", "Pittsburgh Sleep Quality Index-PSQI", "Coping Style Scale", and "QRISK3 Index". No intervention was applied to the control group throughout the 14-week program; the patients continued with their daily routine activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being registered at the Mental Health and Illnesses Outpatient Clinic of S.U. Faculty of Medicine Hospital,
- •Having been diagnosed with schizophrenia for at least 1 year
- •Being between the ages of 25 and 55,
- •Having scored mild to moderate on the Positive and Negative Syndrome Scale (PANSS)
- •Having access to technological devices such as smartphones, computers, and tablets to watch videos from a YouTube channel.
排除标准
- •Having physical, mental, visual, or hearing disabilities,
- •Being involved in a program similar to the intervention to be applied,
- •Having a condition that would prevent them from exercising,
- •Having a diagnosis of heart disease or stroke.
研究组 & 干预措施
Intervention
The intervention group was a group of 25 people consisting of patients with schizophrenia who followed the 14-week Mindfulness and Web-Based Physical Activity Program.
干预措施: the Mindfulness and Web-Based Physical Activity Program (Behavioral)
Control
No intervention was applied to the control group throughout the 14-week program; the patients continued with their daily routine activities.
结局指标
主要结局
Mental Well-Being total mean score
时间窗: From enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeks
The Mental Well-Being Scale scores range from 14 to 70 points. A higher score on the scale indicates a higher level of mental well-being.
Sleep Quality total mean score
时间窗: From enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeks
Pittsburgh sleep quality index (PSQI) scores range from 0 to 21 points. A total score greater than 5 indicates "poor sleep quality".
Self-Confident Approach, Optimistic Approach, Helpless Approach, Submissive Approach, and Seeking of Social Support total mean score
时间窗: From enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeks
The 30-item Coping style scale (CSS) consists of a total of five subscales: Self-Confident Approach, Optimistic Approach, Helpless Approach, Submissive Approach, and Seeking of Social Support. The scale is evaluated based on its subdimensions. The scale has no total score. The total scores to be obtained from the sub-dimensions are as follows: 21 for self-confident approach, 15 for optimistic approach, 24 for helpless approach, 18 for submissive approach, and for 12 for seeking of social support. In the evaluation of the scale, the increase in scores obtained from the factors of self-confident, optimistic, and seeking of social support indicates that coping with stress is effective; whereas the increase in scores obtained from the factors of helpless approach and submissive approach shows that ineffective methods are being used to cope with stress. A high score on the sub-dimensions indicates that the individual uses the respective approach more frequently.
次要结局
- Cardiovascular Risk(From enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeks)