Efficacy of an Smartphone App Intervention Based on Self-Compassion for Mental Health Among University Students During and After Covid-19: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 主要终点
- Change in Anxiety
研究概览
简要总结
Since the beginning of Covid-19, there has been an increase in the incidence of mental disorders and psychopathological symptoms, such as depression, anxiety and stress, among university students. Even with the end of social distancing, many students still have losses in emotional well-being, so psychotherapeutic interventions are important for the recovery and promotion of the mental health of this public. Interventions based on self-compassion have been associated with improving the mental health of different audiences, either by reducing psychopathological symptoms (such as anxiety) or improving positive constructs associated with mental health, such as hope and optimism. One way to administer interventions based on self-compassion is through mHealth technologies, which have been consolidating since the pandemic. Some studies sought to assess the benefits of self-compassion-based interventions administered in the mHealth format among university students suggest that they have acceptability and are effective regarding indicators of emotional well-being. However, in Brazil, there is still no digital intervention for the cultivation of self-compassion among university students, which could help to mitigate the deleterious effects of the pandemic on mental health. Considering this gap, an intervention based on self-compassion administered via a smartphone app called "Eu + Compassivo" was developed. The present study seeks to evaluate its efficacy in mental health indicators, both psychopathological symptoms and Positive Psychology constructs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be enrolled in a course that originally works in the face-to-face format
- •Having basic knowledge of the use of smartphones
- •Owning a smartphone with internet access and the Android or IOS system
- •At least mild depressive, anxiety or stress symptoms
排除标准
- •Diagnosed with any serious and persistent mental disorder
研究组 & 干预措施
Control
This group will be made up of a waiting list.
Intervention
This is group wil use "Eu + Compassivo" app.
干预措施: mHealth Intervention Based on Self-Compassion (Behavioral)
结局指标
主要结局
Change in Anxiety
时间窗: T1 (pre), T2 (6-week)
Depression, Anxiety and Stress Scale (DASS-21) - The measure has 21 items arranged in 3 dimensions (depression, anxiety and stress) through a Likert scale ranging from "did not apply to me at all" (0) to "applied to me very much, or most of the time" (3). The sum of the items provides a score between 0 and 21 regarding anxiety. The higher the score, the greater the anxiety.
Change in Stress
时间窗: T1 (pre), T2 (6-week)
Depression, Anxiety and Stress Scale (DASS-21) - The measure has 21 items arranged in 3 dimensions (depression, anxiety and stress) through a Likert scale ranging from "did not apply to me at all" (0) to "applied to me very much, or most of the time" (3). The sum of the items provides a score between 0 and 21 regarding stress. The higher the score, the greater the stress.
Change in Depression
时间窗: T1 (pre) to T2 (6-week)
Depression, Anxiety and Stress Scale (DASS-21) - The measure has 21 items arranged in 3 dimensions (depression, anxiety and stress) through a Likert scale ranging from "did not apply to me at all" (0) to "applied to me very much, or most of the time" (3). The sum of the items provides a score between 0 and 21 regarding depression. The higher the score, the greater the depression.
Change in Self-Compassion
时间窗: T1 (pre), T2 (6-week)
Self-Compassion Scale - The measure has 26 items scored on a Likert scale, ranging from "almost never" (1) to "almost always" (5). The higher the score, the greater the sel-compassion.
Change in Compassion
时间窗: T1 (pre), T2 (6-week)
Santa Clara Brief Compassion Scale - The measure has 5 items arranged on a Likert scale, ranging from "not at all true for me" (1) to "very true for me" (7). The higher the score, the greater the compassion.
Change in Emotional Well-Being
时间窗: T1 (pre), T2 (6-week)
Well-being Index (WHO-5) - It is a generic measure that assesses emotional well-being. It has 5 items, ranging from "at no time" (0) to "all the time" (5) on a Likert scale, providing a score that varies between 0 and 25. The higher the score, the greater the emotional well-being.
次要结局
- Change in Optimism(T1 (pre), T2 (6-week))
- Change in Life Satisfaction(T1 (pre), T2 (6-week))
- Change in Hope(T1 (pre), T2 (6-week))
- Change in Emotional Self-Regulation(T1 (pre), T2 (6-week))
- Change in Positive Affect(T1 (pre), T2 (6-week))
- Change in Negative Affect(T1 (pre), T2 (6-week))
研究者
Bruno Luis Schaab
Principal Investigator
Federal University of Health Science of Porto Alegre