A Telemedicine Brief Mindfulness Intervention in Post-COVID-19

NCT ID: NCT05175807

Last Updated: 2022-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-19
• Study Completion Date: 2022-12-31

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.

Conditions

Post COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Mindfulness Group_1

The 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.

Group Type: EXPERIMENTAL

Mindfulness

Intervention Type: OTHER

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

Waiting List Group_2

In 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness

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

Intervention Type: OTHER

Eligibility Criteria

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)).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Paolo Banfi

MD, Chief of the Cardio-Respiratory Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Paolo Banfi, MD

Role: CONTACT

pabanfi@dongnocchi.it

0240308812 ext. 0039

Eleonora Volpato, PhD

Role: CONTACT

evolpato@dongnocchi.it

0240308812 ext. 0039

Facility Contacts

Paolo Banfi, MD

Role: primary

pabanfi@dongnocchi.it

0240308812 ext. 0039

Eleonora Volpato, PhD

Role: backup

evolpato@dongnocchi.it

0240308812 ext. 0039

References

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 472086 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15183601 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

FDG_MNF-COVID19

Identifier Type: -

Identifier Source: org_study_id