A Telemedicine Brief Mindfulness Intervention in Post-COVID-19

Post COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05175807
• Other study ID #: FDG_MNF-COVID19
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2021
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Paolo Banfi, MD
• Phone: 0240308812
• Email: pabanfi[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)).

Related Conditions & MeSH terms

• COVID-19
• Post COVID-19

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus	Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View Citation

Löwe B, Kroenke K, Herzog W, Gräfe 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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline at 3 weeks and at 3 months
Secondary	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.	Change from baseline at 3 weeks and at 3 months
Secondary	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	Change from baseline at 3 weeks and at 3 months
Secondary	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.	Change from baseline at 3 weeks and at 3 months
Secondary	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.	Change from baseline at 3 weeks and at 3 months
Secondary	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.	Change from baseline at 3 weeks and at 3 months
Secondary	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)	Change from baseline at 3 weeks and at 3 months
Secondary	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)	Change from baseline at 3 weeks and at 3 months
Secondary	Changes in oxygen saturation (SpO2)	Changes in oxygen saturation (SpO2)	Change from baseline at 3 weeks and at 3 months
Secondary	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.	Change from baseline at 3 weeks and at 3 months
Secondary	CBC, basal cortisolemia ACTH, CPK	CBC, basal cortisolemia ACTH, CPK	Change from baseline at 3 weeks and at 3 months