Post-COVID-19 SyndromeNCT06658340
Feasibility of a Well-being Promotion Self-management Intervention in Post-COVID-19 Patients
A study testing Positivity in Post-COVID in people with Post-COVID-19 Syndrome, run by University of Twente at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-COVID-19 Syndrome
- What is being tested?
- Positivity in Post-COVID
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Jul 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Recent (<5 years) diagnosis of a mood disorder, anxiety disorder or other psychiatric condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-COVID-19 Syndrome
- Being tested
- Positivity in Post-COVID
- Keywords
- mental well-being, positive psychological intervention, self-management, long COVID
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positivity in Post-COVIDBehavioural
A training to support well-being and self-management in patients with post-COVID-19 syndrome
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Positivity in Post-COVID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the intervention exercises
Feasibility is assessed using items asking how often exercises were executed (never, 1, 2 or 3 times).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Between post-intervention (2 weeks after baseline) and at follow-up (6 weeks after baseline).
Secondary outcomes (9)
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.
Measured: Baseline to post-intervention (2 weeks after baseline) and 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Between post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start14 Jul 2024
- Primary completion14 Nov 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Twente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerko Schaap, University of Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658340
- Sponsor's protocol ID
- 241040
- Status last verified
- Mar 2025
- First submitted
- 16 Oct 2024
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positivity in Post-COVID: Promoting Well-being in Patients with Post-COVID-19 Syndrome - a Feasibility and Acceptability Study
- ClinicalTrials.gov ID
- NCT06658340
- Acronym / sponsor ID
- 241040
- Conditions
- Post-COVID-19 Syndrome
- Keywords
- mental well-being, positive psychological intervention, self-management, long COVID
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of TwenteUniversity, hospital or other
- Study start
- 14 Jul 2024 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention: Positivity in Post-COVID | Experimental | Behavioral: Positivity in Post-COVIDParticipants will go through the training using a workbook for 12 consecutive days, once a day for 10-15 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Recent (<5 years) diagnosis of a mood disorder, anxiety disorder or other psychiatric condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positivity in Post-COVIDA training to support well-being and self-management in patients with post-COVID-19 syndrome | Behavioural | Intervention: Positivity in Post-COVID |
Primary outcome
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).
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.
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.
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.
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.
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.
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.
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
9 secondary outcomes
Change in affect
Time frame: Baseline to post-intervention (2 weeks after baseline) and follow-up (6 weeks after baseline)
Change in mental well-being
Time frame: 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)
Change in fatigue
Time frame: Baseline to post-intervention (2 weeks after baseline) and 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)
Change in depression
Time frame: 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)
Change in perceived illness control
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No. Upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positivity in Post-COVID in people with Post-COVID-19 Syndrome, run by University of Twente at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention exercises (time frame: At post-intervention (2 weeks after baseline)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.