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Open, randomized clinical trial: the efficacy of mindfulness intervention on the mental well-being of patients had COVID-19

Open, randomized clinical trial: the efficacy of mindfulness intervention on the mental well-being of post-COVID 19 patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10ths4s7
Enrollment
Unknown
Registered
2024-08-13
Start date
2023-05-27
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anxiety, Emotional stress, depression e fatige

Interventions

Intervention: The intervention group will receive an 8-week program lasting up to 3 (three) hours per week of daily practices from 15 to 34 minutes. On the first day of the week, the group meets (virt
F02.463.551

Sponsors

Instituto Nacional de Infectologia Evandro Chagas - INI / FIOCRUZ
Lead Sponsor
Instituto Nacional de Infectologia Evandro Chagas - INI / FIOCRUZ
Collaborator

Eligibility

Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Over 18 years old and of both sexes; Provide signed free and informed consent for yourself if legally capable, or by your legal representatives for those who do not have legal capacity; Agree to participate in all study visits, procedures and contacts; Post-COVID-19 symptoms (14 days to 12 months from the date of onset of symptoms, with positive antigen PCR or RT-PCR naso/oropharyngeal swab) directly related to Mental Health

Exclusion criteria

Exclusion criteria: Patients with hearing restrictions, with technological restrictions and without post-COVID-19 sequelae

Design outcomes

Primary

MeasureTime frame
Mental well-being: Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). The scale is scored by summing responses to each item answered on a 1 to 5 Likert scale. The minimum scale score is 14 and the maximum is 70. A significant improvement of between 20 and 25% is expected after the study practices for the intervention group—

Secondary

MeasureTime frame
Quality of life: WHO Abbreviated Quality of Life Assessment Instrument (WHOqol bref); Lifestyle: Schedule for Meaning in Life (SMILE-C); Post-COVID-19: Post-COVID-19 Functional Status Scale (PCFS); Fatigue: Fatigue Rating Scale (EAF-10); Stress: (Stress Perception Scale) EPS-10; Generalized Anxiety: Generalized Anxiety Assessment Test (GAD-7); Depression: Patient Health Assessment Test – Depression (PHQ-9); Alcohol abuse: (AUDIT-C); Mindfulness: Mindfulness and Mindfulness Scale (MASS). A significant improvement of between 20 and 25% is expected after the study practices for the intervention group—

Countries

Brazil

Contacts

Public ContactAndre de Siqueira

Instituto Nacional de Infectologia Evandro Chagas - INI / FIOCRUZ

amsiqueira@gmail.com+55-21-96722-2701

Outcome results

None listed

Source: REBEC (via WHO ICTRP)