Positivity in Post-COVID: Promoting Well-being in Patients with Post-COVID-19 Syndrome - a Feasibility and Acceptability Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Feasibility of the intervention exercises
研究概览
简要总结
A training comprised of positive psychological interventions set out to improve mental well-being was developed for post-COVID-19 patients. This study aims to evaluate the feasibility and acceptability of this training.
详细描述
Research has shown that the quality of life and well-being of post-COVID-19 patients are often reduced, and that many patients struggle with self-management tasks, such as symptom management and emotion regulation. Training in self-management skills related to positive emotions, such as positive affect savouring, might help with these and can be provided prior to or in parallel with usual treatment. This study aims to investigate whether a training to improve the mental well-being is feasible and acceptable for people with post-COVID-19 syndrome. The training to be provided is based on previously evaluated sets of positive psychological interventions ('This is your life' and 'Training in Positivity') and adapted to a post-COVID-19 population. As a secondary aim, preliminary effectiveness will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Strongly suspected or clinically confirmed post-COVID-19 syndrome, i.e. confirmed symptoms persisting for at least 3 months after strongly suspected or confirmed SARS-CoV-2 infection
- •Ages ≥18 years
- •Dutch proficiency
- •Provided informed consent
排除标准
- •Recent (<5 years) diagnosis of a mood disorder, anxiety disorder or other psychiatric condition
结局指标
主要结局
Feasibility of the intervention exercises
时间窗: At post-intervention (2 weeks after baseline)
Feasibility is assessed using items asking how often exercises were executed (never, 1, 2 or 3 times).
Acceptability of the intervention exercises - willingness to do again
时间窗: At post-intervention (2 weeks after baseline) and at follow-up (6 weeks after baseline). Interviews are to be conducted soon after the post-questionnaire
Acceptability is assessed using items on willingness to do again, satisfaction, perceived utility, experienced ease-of-use, experienced discomfort, and willingness to recommend to a) other patients and b) friends. Each item is measured on 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), and assessed on an item level.
Acceptability of the intervention exercises - satisfaction
时间窗: At post-intervention (2 weeks after baseline) and at follow-up (6 weeks after baseline). Interviews are to be conducted soon after the post-questionnaire
Acceptability is assessed using items on willingness to do again, satisfaction, perceived utility, experienced ease-of-use, experienced discomfort, and willingness to recommend to a) other patients and b) friends. Each item is measured on 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), and assessed on an item level.
Acceptability of the intervention exercises - perceived utility
时间窗: At post-intervention (2 weeks after baseline) and at follow-up (6 weeks after baseline). Interviews are to be conducted soon after the post-questionnaire
Acceptability is assessed using items on willingness to do again, satisfaction, perceived utility, experienced ease-of-use, experienced discomfort, and willingness to recommend to a) other patients and b) friends. Each item is measured on 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), and assessed on an item level.
Acceptability of the intervention exercises - experienced ease-of-use
时间窗: At post-intervention (2 weeks after baseline)
Acceptability is assessed using items on willingness to do again, satisfaction, perceived utility, experienced ease-of-use, experienced discomfort, and willingness to recommend to a) other patients and b) friends. Each item is measured on 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), and assessed on an item level.
Acceptability of the intervention exercises - experienced discomfort
时间窗: At post-intervention (2 weeks after baseline)
Acceptability is assessed using items on willingness to do again, satisfaction, perceived utility, experienced ease-of-use, experienced discomfort, and willingness to recommend to a) other patients and b) friends. Each item is measured on 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), and assessed on an item level.
Acceptability of the intervention exercises - willingness to recommend
时间窗: At post-intervention (2 weeks after baseline)
Acceptability is assessed using items on willingness to do again, satisfaction, perceived utility, experienced ease-of-use, experienced discomfort, and willingness to recommend to a) other patients and b) friends. Each item is measured on 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), and assessed on an item level.
Acceptability of the intervention exercises - interviews
时间窗: Between post-intervention (2 weeks after baseline) and at follow-up (6 weeks after baseline).
Acceptability will be further explored via in-depth interviews (optional in addition to the post- and follow-up questionnaires) and assessed using thematic analysis
次要结局
- Change in affect(Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline))
- Change in mental well-being(Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline))
- Change in post-COVID symptom severity and functionality(Baseline to follow-up (6 weeks after baseline))
- Change in fatigue(Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline))
- Change in anxiety(Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline))
- Change in depression(Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline))
- Change in ability to adapt(Baseline to follow-up (6 weeks after baseline))
- Change in perceived illness control(Baseline to follow-up (6 weeks after baseline))
- Perceived overall impact(Between post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline))
研究者
Gerko Schaap
Principal investigator
University of Twente