Effectivity of an Occupational-self-analysis Intervention Through a Mobile Application (OcupApp) in People With Anxiety or Depression: A Randomised Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 134
- 主要终点
- The World Health Organization Quality of Life (WHOQOL-BREF)
研究概览
简要总结
The goal of this clinical trial is to test the effectiveness of the use of mobile application ("OcupApp") to generate a personal self-analysis about meaningful activities in which adults between the ages of 50 and 70 with anxiety and subclinical depression participant.
A randomized study will be carried out comparing the effects of the use of the application "OcupApp" with a control intervention on the quality of life related to health, mental health, frequency of participation on meaningful activities, and perceived occupational balance.
详细描述
OcupApp is a mobile application developed within the research team, which aims to promote occupational self-analysis in adults with depression and/or anxiety. The mobile application allows to offer feedback to participants about the meaning of the activities they carry out daily and their perception of occupational balance, which generates a subjective self-reflection that can lead to the implementation of some personal changes in their weekly routine. For this, the person must register the activities they carry out throughout a week and mark each one of them with a punctuation related to the meaning of the following dimensions: identity, pleasure, competence, importance and value of the activity by other people. The punctuation give will be on a Likert-type scale from 1 to 5. The application also allows to collect other information such as where the activity takes place, its duration, and the people with whom it is carried out. Also, at the end of the week, the application will ask users about their perceived occupational balance. All the information registered in the mobile application will be returned to the person in a dynamic and understandable way. Based on this, the person can establish two goals to accomplish. In this sense, OcupApp will offer personalized recommendations based on the objectives to be achieved related to the dimensions of meaning.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Masking will be single blind since the researchers will know the assigned arm. Participants will know the group they belong, but not the hypotheses of the study or the superiority that is sought of one intervention over the other. However, data evaluators will remain blind to the allocation of patients to group.
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a smarthphone and know how to use mobile apps to exchange information.
- •Have a low or moderate depression (DEP 5 <= 4) or low or moderate anxiety (ANX5 <= 3) or DEP5 or ANX5 =3).
排除标准
- •Have a serious mental illness or psychosis.
- •Have a diagnosis of dementia
- •Have language problems or cognitive alterations that doesn't allow comprehension of assessment tools.
结局指标
主要结局
The World Health Organization Quality of Life (WHOQOL-BREF)
时间窗: 15 minutes
The WHOQOL is a generic, multidimensional profile for assessing quality of life with 26 questions; 2 related to their general quality of life and their satisfaction with their health status and 24 item-version assessing 4 domains of quality of life (physical health, psychological health, social relations and environment).
次要结局
- The General Health Questionnaire (GHQ).(10 minutes)
研究者
María Rodríguez Bailón
"OcupApp": Development and effectiveness of a mobile application for the involvement in meaningful activities in the elderly population.
University of Malaga