Feasibility of a Well-being Promotion Self-management Intervention in Post-COVID-19 Patients

Positivity in Post-COVID: Promoting Well-being in Patients with Post-COVID-19 Syndrome - a Feasibility and Acceptability Study

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.

Study Overview

• Status: Completed
• Conditions: Post-COVID-19 Syndrome
• Intervention / Treatment: Behavioral: Positivity in Post-COVID

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Enschede, Netherlands, 7500 AE
    • University of Twente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention: Positivity in Post-COVID; Participants will go through the training using a workbook for 12 consecutive days, once a day for 10-15 minutes.	Behavioral: Positivity in Post-COVID; A training to support well-being and self-management in patients with post-COVID-19 syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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)
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)
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)

Other Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: University of Twente

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2024
• Primary Completion (Actual): November 14, 2024
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: self-management; mental well-being; long COVID; positive psychological intervention
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Disease; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Syndrome
• Other Study ID Numbers: 241040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No