A Telemedicine Brief Mindfulness Intervention in Post-COVID-19
- Conditions
- Post COVID-19
- Interventions
- Other: Mindfulness
- Registration Number
- NCT05175807
- Lead Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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)).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mindfulness Group_1 Mindfulness 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.
- Primary Outcome Measures
Name Time Method Symptoms of Post-Traumatic Stress Disorder (PTSD) Change from baseline at 3 weeks and at 3 months 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.
- Secondary Outcome Measures
Name Time Method Depression Change from baseline at 3 weeks and at 3 months Depression, detected through the Patient Health Questionnaire (PHQ-9) (Löwe, Kroenke, Herzog, \& Gräfe, 2004). Each item is evaluated on a severity scale ranging from 0 to 3 where the respondent is asked to rate how often each symptom occurred over the last 2 weeks (0-not at all; 1-several days; 2-more than half of the days or 3-nearly every day), yielding a total score ranging from 0-27. The respondent is also asked how the identified problems have interfered with work, home and/or social life, however responses to this item are not scored or included in the total score.
Score interpretation:
1-4 minimal depression; 5-9 mild depression; 10-14 moderate depression; 15-19 moderately severe depression; and 20-27 severe depressionChanges with respect to respiratory function Change from baseline at 3 weeks and at 3 months Changes with respect to respiratory function, as measured by Forced Vital Capacity (CVF), Forced Expiratory Forced Expiratory Volume in 1 Second (VEF1) and Tiffenau's Index (VEF1/CVF)
Changes in arterial blood gas analysis (ABG) Change from baseline at 3 weeks and at 3 months Changes in arterial blood gas analysis (ABG), which measures oxygen tension (PaO2) and that of carbon dioxide (PaCO2)
CBC, basal cortisolemia ACTH, CPK Change from baseline at 3 weeks and at 3 months CBC, basal cortisolemia ACTH, CPK
Anxiety 2006), at baseline, 3 weeks, 3 months after recruitment. Change from baseline at 3 weeks and at 3 months Anxiety, detected through the General Anxiety Disorder (GAD-7)(R L Spitzer, K Kroenke, Williams, \& Lowe, 2006). The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions.
GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.
When used as a screening tool, further evaluation is recommended when the score is 10 or greater.Psychological distress Change from baseline at 3 weeks and at 3 months Psychological distress, measured by the Perceived Stress Scale (PSS)(Cohen, S., Kamarck, T., \& Mermelstein, 1994). PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. A short 4 item scale can be made from questions 2, 4, 5 and 10 of the PSS 10 item scale.
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 Counterfactual thinking and peritraumatic emotions of guilt, shame, and fear in relation to stressful events stressful events as measured by the State Shame and Guilt Scale-8 (Cavalera, Pepe, Zurloni, Diana, \& Realdon, 2017) and the Peritraumatic Perceptions of Fear and life threat (Breiding et al., 2015;Tran \& Beck, 2019). Scoring Each scale consists of 5 items: Shame - Items 1, 3, 5, 7, 9 Guilt - Items 2, 4, 6, 8, 10 All items are scored in a positive direction.
Changes in oxygen saturation (SpO2) Change from baseline at 3 weeks and at 3 months Changes in oxygen saturation (SpO2)
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. Change from baseline at 3 weeks and at 3 months 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.
Well-being Change from baseline at 3 weeks and at 3 months Well-being, as measured by the Psychological General Well-being Index (PGWBI)(Chassany, Dimenas, Dubois, Wu, \& Dupoy, 2004; Grossi \& Compare, 2014). The PGWBI global score represents the sum of all items and ranges from 0 to 110. Higher scores indicate greater psychological well-being.
Trial Locations
- Locations (1)
IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi
🇮🇹Milan, Italy