A Telemedicine Brief Mindfulness Intervention in Post-COVID-19

Don Carlo Gnocchi Onlus Foundation

Status: Unknown

Conditions: Post COVID-19

Treatments: Other: Mindfulness

Study type: Interventional

Funder types: Other

Identifiers

NCT05175807

FDG_MNF-COVID19

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Mindfulness Group_1

Experimental group

Description:

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.

Treatment:

Other: Mindfulness

Waiting List Group_2

No Intervention group

Description:

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.