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

March 24, 2025 updated by: Gerko Schaap, University of Twente

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of the intervention exercises
Time Frame: At post-intervention (2 weeks after baseline)
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
At post-intervention (2 weeks after baseline)
Acceptability of the intervention exercises - experienced discomfort
Time Frame: 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.
At post-intervention (2 weeks after baseline)
Acceptability of the intervention exercises - willingness to recommend
Time Frame: 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.
At post-intervention (2 weeks after baseline)
Acceptability of the intervention exercises - interviews
Time Frame: 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
Between post-intervention (2 weeks after baseline) and at follow-up (6 weeks after baseline).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in mental well-being
Time Frame: 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.
Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline)
Change in post-COVID symptom severity and functionality
Time Frame: 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).
Baseline to follow-up (6 weeks after baseline)
Change in anxiety
Time Frame: 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.
Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline)
Change in depression
Time Frame: 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.
Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline)
Change in ability to adapt
Time Frame: 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.
Baseline to follow-up (6 weeks after baseline)
Change in perceived illness control
Time Frame: 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.
Baseline to follow-up (6 weeks after baseline)
Perceived overall impact
Time Frame: 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).
Between post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline)
Change in affect
Time Frame: 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.
Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline)
Change in fatigue
Time Frame: 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.
Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recommendations for the intervention exercises
Time Frame: Between post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Twente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 14, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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