NCT05175807

A Telemedicine Brief Mindfulness Intervention in Post-COVID-19

Status unknown NA Last updated 4 January 2022

What this trial tests

NA trial testing Mindfulness in Post COVID-19 in 40 participants. Status unknown.

Timeline

19 June 2020

Primary endpoint
30 July 2021

31 December 2022

Quick facts

Lead sponsor	Fondazione Don Carlo Gnocchi Onlus
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	40
Start date	19 June 2020
Primary completion	30 July 2021
Estimated completion	31 December 2022
Sites	1 location across Italy

Drugs / interventions tested

• Mindfulness

Conditions studied

• Post COVID-19 — all drugs for Post COVID-19 →

Sponsor

Fondazione Don Carlo Gnocchi Onlus — full company profile →

Who can join

18 and older, any sex, with Post COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.