Positivity in Post-COVID: Promoting Well-being in Patients with Post-COVID-19 Syndrome - a Feasibility and Acceptability Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Twente
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Feasibility of the intervention exercises
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Recent (<5 years) diagnosis of a mood disorder, anxiety disorder or other psychiatric condition
Outcomes
Primary Outcomes
Feasibility of the intervention exercises
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- 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))
Investigators
Gerko Schaap
Principal investigator
University of Twente