A Telemedicine Brief Mindfulness Intervention in Post-COVID-19

NCT05175807 | Unknown DMC

• 1 other identifier: FDG_MNF-COVID19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Post COVID-19; Mindfulness; Randomized Controlled Trial; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Anxiety 2006), at baseline, 3 weeks, 3 months after recruitment.

  Change from baseline at 3 weeks and at 3 months

• Depression

  Change from baseline at 3 weeks and at 3 months

• Psychological distress

  Change from baseline at 3 weeks and at 3 months

• 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

• Well-being

  Change from baseline at 3 weeks and at 3 months

Study Arms (2)

Mindfulness Group_1

EXPERIMENTAL

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.

Other: Mindfulness

Waiting List Group_2

NO INTERVENTION

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.

Interventions

Mindfulness OTHER

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

Mindfulness Group_1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with lung cancer;
• Documented psychiatric disorders;
• Immunodepression;
• Patients with terminal or neurodegenerative diseases (e.g., other forms of cancer, Amyotrophic Lateral Sclerosis (ALS)).

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Catholic University of the Sacred Heart: collaborator

Study Sites (1)

IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi

Milan, 20148, Italy

RECRUITING

Related 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

  BACKGROUND

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

  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

  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.

  PMID: 472086 BACKGROUND

• 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.

  PMID: 15183601 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Paolo Banfi, MD

CONTACT

0240308812; pabanfi@dongnocchi.it

Eleonora Volpato, PhD

CONTACT

0240308812; evolpato@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Chief of the Cardio-Respiratory Rehabilitation

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: January 4, 2022
• Study Start: June 19, 2020
• Primary Completion: July 30, 2021
• Study Completion: December 31, 2022
• Last Updated: January 4, 2022

Record last verified: 2021-12

Locations

IT (1)