Feasibility of a Well-being Promotion Self-management Intervention in Post-COVID-19 Patients
- Conditions
- Post-COVID-19 Syndrome
- Registration Number
- NCT06658340
- Lead Sponsor
- University of Twente
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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
- Recent (<5 years) diagnosis of a mood disorder, anxiety disorder or other psychiatric condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Feasibility of the intervention exercises 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 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 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 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 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 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 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 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 Outcome Measures
Name Time Method Change in affect Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline) Measured with the 20-item Positive and Negative Affect Schedule (PANAS). Positive affect (10 items) and negative affect (10 items) are assessed on a scale from 1 (not at all) to 5 (extremely) and calculated as sum scores. Higher scores indicate larger levels of positive and negative affect.
Change in mental well-being Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline) Measured with the 14-item Mental Health Continuum short form (MHC-SF), which assesses three subscales (emotional well-being via 3 items; psychological well-being via six items; and social well-being via five items) and a total mental well-being scale. Mean scores range between 0 - 5, with higher scores indicating more well-being.
Change in post-COVID symptom severity and functionality Baseline to follow-up (6 weeks after baseline) Measured with the modified COVID-19 Yorkshire Rehabilitation Scale (C19YRSm) resulting in four subscales: symptom severity (0 - 30; higher scores indicating higher severity); functional ability (0 - 15; higher scores indicating higher dysfunction); presence of other symptoms (0 - 25; higher scores indicating more symptoms); and self-reported general health (0 - 10; higher scores indicating better health).
Change in fatigue Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline) Measured with the 4-item Short Fatigue Questionnaire (SFQ), resulting in one sum score of 4 - 28. Higher scores indicate more severe fatigue with scores ≥18 signalling clinically severe fatigue.
Change in anxiety Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline) Measured with the 14-item Hospital Anxiety and Depression Scale (HADS), with one subscale (7 items) on anxiety and one subscale (7 items) on depression. Sum scores range between 0 - 21 with higher scores (\>7) indicating higher severity.
Change in depression Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline) Measured with the 14-item Hospital Anxiety and Depression Scale (HADS), with one subscale (7 items) on anxiety and one subscale (7 items) on depression. Sum scores range between 0 - 21 with higher scores (\>7) indicating higher severity.
Change in ability to adapt Baseline to follow-up (6 weeks after baseline) Ability to adapt is measured with the 10-item Generic Sense of Ability of Adapt Scale (GSAAS), resulting in a mean score between 0 - 4; higher scores indicating better sense of adaptability.
Change in perceived illness control Baseline to follow-up (6 weeks after baseline) Illness perceptions, including perceived illness control and perceived treatment control, are measured with the brief Illness Perception Questionnaire (IPQ-K). Items are scored on range from 0 - 10, for control items higher scores indicating better perceived control.
Perceived overall impact Between post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline) Perceived impact of the intervention will be explored via in-depth interviews (optional in addition to the post- and follow-up questionnaires).
Trial Locations
- Locations (1)
University of Twente
🇳🇱Enschede, Netherlands