Post COVID-19
Conditions
Keywords
Post COVID-19, Mindfulness, Randomized Controlled Trial, Post Traumatic Stress Disorder
Brief 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, 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. 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.
Interventions
OTHERMindfulness
Mindfulness (e.g., body scan, gentle yoga, sitting, grounding, and walking meditation), relaxation techniques, and cognitive rehabilitation exercises.
Sponsors
Catholic University of the Sacred Heart
Fondazione Don Carlo Gnocchi Onlus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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)).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of Post-Traumatic Stress Disorder (PTSD) | Change from baseline at 3 weeks and at 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety 2006), at baseline, 3 weeks, 3 months after recruitment. | Change from baseline at 3 weeks and at 3 months | 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. |
| Depression | Change from baseline at 3 weeks and at 3 months | 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 |
| Psychological distress | Change from baseline at 3 weeks and at 3 months | 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. |
| Counterfactual thinking and peritraumatic emotions of guilt, shame, and fear in relation to the events stressful events | Change from baseline at 3 weeks and at 3 months | 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. |
| Well-being | Change from baseline at 3 weeks and at 3 months | 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. |
| Changes with respect to respiratory function | Change from baseline at 3 weeks and at 3 months | 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) |
| Changes in arterial blood gas analysis (ABG) | Change from baseline at 3 weeks and at 3 months | Changes in arterial blood gas analysis (ABG), which measures oxygen tension (PaO2) and that of carbon dioxide (PaCO2) |
| Changes in oxygen saturation (SpO2) | Change from baseline at 3 weeks and at 3 months | Changes in oxygen saturation (SpO2) |
| 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 from baseline at 3 weeks and at 3 months | 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. |
| CBC, basal cortisolemia ACTH, CPK | Change from baseline at 3 weeks and at 3 months | CBC, basal cortisolemia ACTH, CPK |
Countries
Italy
Contacts
Primary ContactPaolo Banfi, MD
Backup ContactEleonora Volpato, PhD
Outcome results
None listed