Clinical trial NCT06658340: Feasibility of a Well-being Promotion Self-management Intervention in Post-COVID-19 Patients
Official title: Positivity in Post-COVID: Promoting Well-being in Patients with Post-COVID-19 Syndrome - a Feasibility and Acceptability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-COVID-19 Syndrome
Keywords: mental well-being
positive psychological intervention
self-management
long COVID
Lead sponsor: University of Twente
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the intervention exercises
timeFrame: At post-intervention (2 weeks after baseline)
measure: Acceptability of the intervention exercises - willingness to do again
timeFrame: 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: Acceptability of the intervention exercises - satisfaction
timeFrame: 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: Acceptability of the intervention exercises - perceived utility
timeFrame: 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: Acceptability of the intervention exercises - experienced ease-of-use
timeFrame: At post-intervention (2 weeks after baseline)
measure: Acceptability of the intervention exercises - experienced discomfort
timeFrame: At post-intervention (2 weeks after baseline)
measure: Acceptability of the intervention exercises - willingness to recommend
timeFrame: At post-intervention (2 weeks after baseline)
measure: Acceptability of the intervention exercises - interviews
timeFrame: Between post-intervention (2 weeks after baseline) and at follow-up (6 weeks after baseline).
Secondary outcomes:
measure: Change in affect
timeFrame: Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline)
measure: Change in mental well-being
timeFrame: Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline)
measure: Change in post-COVID symptom severity and functionality
timeFrame: Baseline to follow-up (6 weeks after baseline)
measure: Change in fatigue
timeFrame: Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline)
measure: Change in anxiety
timeFrame: Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline)
measure: Change in depression
timeFrame: Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline)
measure: Change in ability to adapt
timeFrame: Baseline to follow-up (6 weeks after baseline)
measure: Change in perceived illness control
timeFrame: Baseline to follow-up (6 weeks after baseline)
measure: Perceived overall impact
timeFrame: Between post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline)
Other outcomes:
measure: Recommendations for the intervention exercises
timeFrame: Between post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline)
Locations:
city: Enschede
country: Netherlands
facility: University of Twente
Study officials:
References: