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Post COVID-19NCT05175807

A Telemedicine Brief Mindfulness Intervention in Post-COVID-19

A study testing Mindfulness in people with Post COVID-19, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background: Several studies suggest that SARS survivors still presented with high levels of psychological distress overall at 1, 3, 12, and 18 months after hospital discharge. Nonetheless, there are no data available in the literature regarding the implementation of interventions that are psychological interventions… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post COVID-19
What is being tested?
Mindfulness
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteItaly
Study dates
19 Jun 2020to 31 Dec 2022
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

  • Previously positive for COVID-19 and now negative and undergoing treatment Pulmonary rehabilitation;
  • Compatibility to participate in the study as judged by the physician;
  • Able to provide Informed Consent.

Who cannot join

  • The physician's unfavorable opinion of inclusion in the study because he or she is unable to provide Informed Consent;
  • Patients with lung cancer;
  • Documented psychiatric disorders;
  • Immunodepression;
  • Patients with terminal or neurodegenerative diseases (e.g., other forms of cancer, Amyotrophic Lateral Sclerosis (ALS)).

Trial locations and contacts

1 site in 1 country.

Paolo Banfi, MD contact

0240308812 ext. 0039

pabanfi@dongnocchi.it

Eleonora Volpato, PhD contact

0240308812 ext. 0039

evolpato@dongnocchi.it

Italy1 site, 1 recruiting

  • IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi

    Milan, 20148

    Paolo Banfi, MD, 0240308812 ext. 0039, pabanfi@dongnocchi.it

    Eleonora Volpato, PhD, 0240308812 ext. 0039, evolpato@dongnocchi.it

    Recruiting

Other trials in Italy

About this study

Official title: Application of a Telemedicine Brief Mindfulness Intervention in Post-COVID-19: a Pilot Randomized and Controlled Trial

Background: Several studies suggest that SARS survivors still presented with high levels of psychological distress overall at 1, 3, 12, and 18 months after hospital discharge. Nonetheless, there are no data available in the literature regarding the implementation of interventions that are psychological interventions, let alone specific ones. In particular, the practice of mindfulness, formalized in the protocols such as Mindfulness Based Stress Reduction (MBSR) and Mindfulness Based Cognitive Therapy (MBCT). Based Cognitive Therapy (MBCT), have proved to be very effective in reducing stress related to chronic conditions and of depression. However, these protocols typically require a high level of engagement for participants, which is why, in the present exploratory study, the investigators opted to evaluate the implementation of a Mindfulness-based protocol that is short and less intense, but which has shown good results on health-related outcomes, even with a single session.

Objectives: In this perspective, it becomes important to detect the presence of psychological distress in those who have contracted COVID-19 and are now undertaking a rehabilitation program, from the perspective of promoting well-being and prevention of possible aggravation if not prolongation of mental suffering in the long term.

Read more

Study Design: Randomized and Controlled (RCT), two-arm pilot study with three data captures (baseline=T0, 3 weeks=T1, 3 months=T2).

Participants: People who have previously tested positive for COVID-19, now negative and hospitalized at the IRCCS Santa Maria Nascente of the Fondazione Don Carlo Gnocchi in Milan.

Conditions
Post COVID-19
Being tested
Mindfulness
Keywords
Post COVID-19, Mindfulness, Randomized Controlled Trial, Post Traumatic Stress Disorder
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MindfulnessOther

    Mindfulness (e.g., body scan, gentle yoga, sitting, grounding, and walking meditation), relaxation techniques, and cognitive rehabilitation exercises.

Study groups in NCT05175807
Study groupRoleWhat they receive
Mindfulness Group_1ExperimentalThe intervention will be characterized by be based on Mindfulness exercises (e.g. body scan, gentle yoga, sitting, grounding and walking meditation), relaxation techniques and cognitive rehabilitation exercises. walking), relaxation techniques and cognitive rehabilitation exercises. The objective is to provide specific practical skills to learn how to deal with difficult and/or stressful situations managing emotions and intercurrent thoughts. The intervention is proposed to last for a total of 5-6 sessions lasting 45 minutes each, two sessions per week, for a three-week commitment. In addition, between sessions, reflection materials, readings or exercises will be offered. The intervention will be conducted in telemedicine by a Psychologist, who has experience in conducting these interventions and who receives regular supervision. The sessions will be conducted through special platform and audio-recorded to ensure the reliability of the data collected, prior consent.
Receives: Other: Mindfulness
Waiting List Group_2No interventionIn both groups the "usual care" or usual treatment, will consist of the usual daily medical examinations of the department, respiratory and motor physiotherapy sessions. The Group 2, therefore, will not be submitted to other type of treatment outside of that previewed near O.U. for the course of the first three weeks, during which they will be placed on the waiting list. Once the Once the assessment is carried out after 3 weeks, we will proceed to implement the intervention proposed to the Group 1. If the participant has already been discharged from the structure, it will still be possible to proceed with the intervention, since it is online. If the participant has already been discharged from the structure, you can still proceed with the intervention, since this is in telemedicine, in order to promote the continuity hospital-territory.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptoms of Post-Traumatic Stress Disorder (PTSD)

    Symptoms of Post-Traumatic Stress Disorder (PTSD) as measured by the Impact of Event Scale (IES) (Horowitz, Wilner, \& Alvarez, 1979). The revised version of the Impact of Event Scale (IES-r) has seven additional questions and a scoring range of 0 to 88.

    On this test, scores that exceed 24 can be quite meaningful. High scores have the following associations.

    Measured: Change from baseline at 3 weeks and at 3 months

Secondary outcomes (10)

  1. Anxiety 2006), at baseline, 3 weeks, 3 months after recruitment.

    Anxiety, detected through the General Anxiety Disorder (GAD-7)(R L Spitzer, K Kroenke, Williams, \& Lowe, 2006). The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions.

    GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.

    When used as a screening tool, further evaluation is recommended when the score is 10 or greater.

    Measured: Change from baseline at 3 weeks and at 3 months

  2. Depression

    Depression, detected through the Patient Health Questionnaire (PHQ-9) (Löwe, Kroenke, Herzog, \& Gräfe, 2004). Each item is evaluated on a severity scale ranging from 0 to 3 where the respondent is asked to rate how often each symptom occurred over the last 2 weeks (0-not at all; 1-several days; 2-more than half of the days or 3-nearly every day), yielding a total score ranging from 0-27. The respondent is also asked how the identified problems have interfered with work, home and/or social life, however responses to this item are not scored or included in the total score.

    Score interpretation:

    1-4 minimal depression; 5-9 mild depression; 10-14 moderate depression; 15-19 moderately severe depression; and 20-27 severe depression

    Measured: Change from baseline at 3 weeks and at 3 months

  3. Psychological distress

    Psychological distress, measured by the Perceived Stress Scale (PSS)(Cohen, S., Kamarck, T., \& Mermelstein, 1994). PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. A short 4 item scale can be made from questions 2, 4, 5 and 10 of the PSS 10 item scale.

    Measured: Change from baseline at 3 weeks and at 3 months

  4. Counterfactual thinking and peritraumatic emotions of guilt, shame, and fear in relation to the events stressful events

    Counterfactual thinking and peritraumatic emotions of guilt, shame, and fear in relation to stressful events stressful events as measured by the State Shame and Guilt Scale-8 (Cavalera, Pepe, Zurloni, Diana, \& Realdon, 2017) and the Peritraumatic Perceptions of Fear and life threat (Breiding et al., 2015;Tran \& Beck, 2019). Scoring Each scale consists of 5 items: Shame - Items 1, 3, 5, 7, 9 Guilt - Items 2, 4, 6, 8, 10 All items are scored in a positive direction.

    Measured: Change from baseline at 3 weeks and at 3 months

  5. Well-being

    Well-being, as measured by the Psychological General Well-being Index (PGWBI)(Chassany, Dimenas, Dubois, Wu, \& Dupoy, 2004; Grossi \& Compare, 2014). The PGWBI global score represents the sum of all items and ranges from 0 to 110. Higher scores indicate greater psychological well-being.

    Measured: Change from baseline at 3 weeks and at 3 months

  6. Changes with respect to respiratory function

    Changes with respect to respiratory function, as measured by Forced Vital Capacity (CVF), Forced Expiratory Forced Expiratory Volume in 1 Second (VEF1) and Tiffenau's Index (VEF1/CVF)

    Measured: Change from baseline at 3 weeks and at 3 months

  7. Changes in arterial blood gas analysis (ABG)

    Changes in arterial blood gas analysis (ABG), which measures oxygen tension (PaO2) and that of carbon dioxide (PaCO2)

    Measured: Change from baseline at 3 weeks and at 3 months

  8. Changes in oxygen saturation (SpO2)

    Changes in oxygen saturation (SpO2)

    Measured: Change from baseline at 3 weeks and at 3 months

  9. Change in CBC, ferritin, fibrinogen, creatinine, electrolytes, transaminases, d-dimer values, immunoelectrophoresis, baseline cortisolemia ACTH, CPK, COVID-19-related serological values of IgG and IgM.

    Change in CBC, ferritin, fibrinogen, creatinine, electrolytes, transaminases, d-dimer values, immunoelectrophoresis, baseline cortisolemia ACTH, CPK, COVID-19-related serological values of IgG and IgM.

    Measured: Change from baseline at 3 weeks and at 3 months

  10. CBC, basal cortisolemia ACTH, CPK

    CBC, basal cortisolemia ACTH, CPK

    Measured: Change from baseline at 3 weeks and at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2022
  2. Study start19 Jun 2020
  3. Primary completion30 Jul 2021
  4. Study completion31 Dec 2022 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05175807
Sponsor's protocol ID
FDG_MNF-COVID19
Status last verified
Dec 2021
First submitted
22 Apr 2021
Last updated
4 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Cavalera, C., Pepe, A., Zurloni, V., Diana, B., & Realdon, O. (2017). A short version of the state shame and guilt scale (SSGS-8). TPM - Testing, Psychometrics, Methodology in Applied Psychology, 24(1), 99-106. https://doi.org/10.4473/TPM24.1.6

  • Cohen, S., Kamarck, T., & Mermelstein, R. (1994). Perceived Stress Scale. In Measuring stress: A guide for health and social scientists (p. 10).

  • Grossi, E., & Compare, A. (2014). Psychological General Well-Being Index (PGWB). In Encyclopedia of Quality of Life and Well-Being Research. https://doi.org/10.1007/978-94-007-0753-5_2309

  • Horowitz M, Wilner N, Alvarez W. Impact of Event Scale: a measure of subjective stress. Psychosom Med. 1979 May;41(3):209-18. doi: 10.1097/00006842-197905000-00004.

    PubMed 472086

  • Lowe B, Kroenke K, Herzog W, Grafe K. Measuring depression outcome with a brief self-report instrument: sensitivity to change of the Patient Health Questionnaire (PHQ-9). J Affect Disord. 2004 Jul;81(1):61-6. doi: 10.1016/S0165-0327(03)00198-8.

    PubMed 15183601

  • Tran, H. N., & Beck, J. G. (2019). Are Peritraumatic Perceptions of Fear/Life Threat and Posttraumatic Negative Self-Conscious Appraisals/Emotions Differentially Associated with PTSD Symptoms? Cognitive Therapy and Research, 43(1), 272-283.

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness in people with Post COVID-19, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 4 Jan 2022. 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 Italy. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Paolo Banfi, MD (0240308812 ext. 0039, pabanfi@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptoms of Post-Traumatic Stress Disorder (PTSD) (time frame: Change from baseline at 3 weeks and at 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05175807, which also lists 6 linked publications.

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 4 Jan 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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