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

NCT06658340 | Completed

• 1 other identifier: 241040
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-COVID-19 Syndrome

Keywords

mental well-being; positive psychological intervention; self-management; long COVID

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (9)

• 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)

Other Outcomes (1)

• Recommendations for the intervention exercises

  Between post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline)

Study Arms (1)

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.

Behavioral: Positivity in Post-COVID

Interventions

Positivity in Post-COVID BEHAVIORAL

A training to support well-being and self-management in patients with post-COVID-19 syndrome

Intervention: Positivity in Post-COVID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Recent (\<5 years) diagnosis of a mood disorder, anxiety disorder or other psychiatric condition

Sponsors & Collaborators

• University of Twente: lead

Study Sites (1)

University of Twente

Enschede, 7500 AE, Netherlands

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Psychological Well-Being

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 26, 2024
• Study Start: July 14, 2024
• Primary Completion: November 14, 2024
• Study Completion: January 31, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)