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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: Positivity in Post-COVID | Experimental | Participants will go through the training using a workbook for 12 consecutive days, once a day for 10-15 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positivity in Post-COVID | Behavioral | A training to support well-being and self-management in patients with post-COVID-19 syndrome |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the intervention exercises | Feasibility is assessed using items asking how often exercises were executed (never, 1, 2 or 3 times). | At post-intervention (2 weeks after baseline) |
| Acceptability of the intervention exercises - willingness to do again | 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. | 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 of the intervention exercises - satisfaction | 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. | 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 of the intervention exercises - perceived utility | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in affect | 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. | Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Recommendations for the intervention exercises | Recommendations for future interventions or iterations, including strengths of the training and motivation to participate, will be explored via in-depth interviews (optional in addition to the post- and follow-up questionnaires). | Between post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Twente | Enschede | 7500 AE | Netherlands |
Upon reasonable request
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| Acceptability of the intervention exercises - experienced ease-of-use |
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. |
| At post-intervention (2 weeks after baseline) |
| Acceptability of the intervention exercises - experienced discomfort | 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. | At post-intervention (2 weeks after baseline) |
| Acceptability of the intervention exercises - willingness to recommend | 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. | At post-intervention (2 weeks after baseline) |
| Acceptability of the intervention exercises - interviews | Acceptability will be further explored via in-depth interviews (optional in addition to the post- and follow-up questionnaires) and assessed using thematic analysis | Between post-intervention (2 weeks after baseline) and at follow-up (6 weeks after baseline). |
| Change in mental well-being | 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. | Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline) |
| Change in post-COVID symptom severity and functionality | 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). | Baseline to follow-up (6 weeks after baseline) |
| Change in fatigue | 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. | Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline) |
| Change in anxiety | 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. | Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline) |
| Change in depression | 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. | Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline) |
| Change in ability to adapt | 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. | Baseline to follow-up (6 weeks after baseline) |
| Change in perceived illness control | 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. | Baseline to follow-up (6 weeks after baseline) |
| Perceived overall impact | Perceived impact of the intervention will be explored via in-depth interviews (optional in addition to the post- and follow-up questionnaires). | Between post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline) |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |