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Mindfulness to improve the Quality of Life of individuals with Chronic Diseases accompanied by the SUS in the State of São Paulo- Brazil

Mindfulness to improve the Quality of Life of individuals with Chronic Conditions Primary Health Care in the State of São Paulo- Brazil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-107wh2sv
Enrollment
Unknown
Registered
2023-12-12
Start date
2019-08-01
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

Hypertension

Interventions

Controlled and randomized study.Users will be divided into two groups: Active Control Group - Health Education Group (GES): users who will receive guidance on food and nutrition education and consciou
Intervention group - Mindfulness group (GM): users who will receive the Mindfulness intervention + conventional treatment guidelines (diet and incentive to practice physical exercises) (n=25). Grupo e
F02.463.551

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Universidade Federal de Pernambuco- Acadêmico de Vitória
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Volunteers diagnosed with cardiovascular disease - systemic arterial hypertension; Diabetes Mellitus; chronic respiratory diseases; chronic kidney disease; chronic liver diseases; bone and joint diseases; psychiatric illnesses, adults and elderly people, of both sexes, with a minimum age of 18 and a maximum of 70 years

Exclusion criteria

Exclusion criteria: Volunteers who are unable to read and/or write and/or understand the assessment questionnaires; moderate to severe cognitive impairment; individuals with decompensation or exacerbation of other Chronic Non-Communicable Diseases; pregnant women; individuals who have some serious psychopathology (for example, psychotic disorder, deep depression or substance use disorder) and/or who practice meditation at the time of the study

Design outcomes

Primary

MeasureTime frame
Expected outcome 1-Evaluate the effects of the intervention on the participants' quality of life - using the WHOQOL-bref (WHO, 1998), with 26 questions, two of which are about quality of life in general (general QOL) and the others represent each of the 24 facets that make up the original instrument and are divided into four domains. ;Outcome found 1- All groups showed an improvement in quality of life over time, in all domains evaluated (p=0.001), although the psychological and environmental domains showed a significant difference depending on the type of intervention.

Secondary

MeasureTime frame
Outcome found 7- all groups showed an increase in scores over time (p=0.0038) in the level of mindfulness, regardless of the type of intervention. However, the highest averages were found in the post-intervention online groups, although no statistical differences were found between the groups. There were also no reported adverse effects on mindfulness practitioners.; Expected outcome 2- Compare the effect of the intervention in face-to-face and online format.;Expected outcome 3- Assess the effects of the intervention on signs and symptoms of anxiety and depression through the Anxiety and Depression Scale (HADS).;Expected outcome 4 Analyze nutritional profile and eating behavior through the Ministry of Health’s “How is your food” (BRASIL, 2018), based on the Food Guide for the Brazilian Population and Three Factor Eating Questionnaire.;Expected outcome 5- Evaluate the Physical exercise self-efficacy scale through the A Physical Exercise Self-Efficacy Scale.;Expected outcome 6- Assess the level of physical activity International Physical Activity Questionnaire (IPAQ), in its short version, validated in Brazil by Matsudo et al (2001).;Expected outcome 7- Evaluate adherence to practices, level of mindfulness and its adverse effects, through the Mindful Attention Awareness Scale (MAAS) and assessment of the effects by self-declaration.;Outcome found 2- All two formats showed positive effects on quality of life and other parameters, depending on the groups analyzed and evaluation time.;Outcome found 3- A decrease in anxiety was noticed in the groups depending on the type of format and intervention, with greater effects in those who received the mindfulness intervention, regardless of the format (p<0.001).;Outcome found 4- There was no change in eating practices either between groups or between assessment times. Regarding nutritional status, there was only a difference in the face-to-face groups between pre-intervention and follow-up (weight loss).;Outcome found 5- There

Countries

Brazil

Contacts

Public ContactLuciana Orange

Universidade Federal de Pernambuco- Acadêmico de Vitória

luciana_orange@hotmail.com+55 (81) 98736-4378

Outcome results

None listed

Source: REBEC (via WHO ICTRP)