Clinical trial NCT05175807: A Telemedicine Brief Mindfulness Intervention in Post-COVID-19
Official title: Application of a Telemedicine Brief Mindfulness Intervention in Post-COVID-19: a Pilot Randomized and Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post COVID-19
Keywords: Post COVID-19
Mindfulness
Randomized Controlled Trial
Post Traumatic Stress Disorder
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Catholic University of the Sacred Heart
First posted: 2022-01-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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)).

Primary outcomes:
measure: Symptoms of Post-Traumatic Stress Disorder (PTSD)
timeFrame: Change from baseline at 3 weeks and at 3 months
Secondary outcomes:
measure: Anxiety 2006), at baseline, 3 weeks, 3 months after recruitment.
timeFrame: Change from baseline at 3 weeks and at 3 months
measure: Depression
timeFrame: Change from baseline at 3 weeks and at 3 months
measure: Psychological distress
timeFrame: Change from baseline at 3 weeks and at 3 months
measure: Counterfactual thinking and peritraumatic emotions of guilt, shame, and fear in relation to the events stressful events
timeFrame: Change from baseline at 3 weeks and at 3 months
measure: Well-being
timeFrame: Change from baseline at 3 weeks and at 3 months
measure: Changes with respect to respiratory function
timeFrame: Change from baseline at 3 weeks and at 3 months
measure: Changes in arterial blood gas analysis (ABG)
timeFrame: Change from baseline at 3 weeks and at 3 months
measure: Changes in oxygen saturation (SpO2)
timeFrame: Change from baseline at 3 weeks and at 3 months
measure: 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.
timeFrame: Change from baseline at 3 weeks and at 3 months
measure: CBC, basal cortisolemia ACTH, CPK
timeFrame: Change from baseline at 3 weeks and at 3 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi
Study officials:
References:
citation: 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
citation: Cohen, S., Kamarck, T., & Mermelstein, R. (1994). Perceived Stress Scale. In Measuring stress: A guide for health and social scientists (p. 10).
citation: 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
citation: 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.
citation: 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.
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.