Status:

UNKNOWN

Mind-Body Therapies in Primary Health Care

Lead Sponsor:

Unidade de Saude da Ilha de Sao Miguel

Conditions:

Psychological Stress

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Mental disorders are among the most common causes of disability globally. Given the high prevalence of mental disorders (57.0%) in Azores islands (Portugal), local primary health care (PHC) services s...

Detailed Description

VIVE mind will be a pragmatic, single-center, randomized controlled trial. Users of PDHC with perceived distress (PSS-10), aged 18 years or over, will be recruited and randomly assigned into experime...

Eligibility Criteria

Inclusion

  • Users of Ponta Delgada Health Center with perceived distress (score higher than 20 for men and higher than 22 for women in PSS-10).

Exclusion

  • Users with recent practice (less than 3 months) of any mind-body therapies;
  • Users with medical contraindications to moderate-to-vigorous intensity physical activities, such as: unstable angina; deep vein thrombosis; recent thromboembolism or embolism; acute systemic infection or fever; atrioventricular block of 2nd grade or higher (without pacemaker); negative deflection of the ST segment deflection of the ST segment \> 2 mm; severe neuro-musculoskeletal dysfunction; severe mitral or aortic insufficiency or stenosis without adequate treatment; decompensated heart failure; resting heart rate above 100 bpm; other decompensated metabolic disorders; pericarditis or acute myocarditis; uncontrolled arrhythmia; uncontrolled resting hypertension (SBP ≥ 180 or DBP ≥ 110); orthostatic hypotension with a fall in SBP\> 20 mmHg or uncontrolled diabetes;
  • Users with physical and/or mental disabilities;
  • Users with severe psychiatric diagnosis or/and active psychosis or
  • Pregnant women.

Key Trial Info

Start Date :

February 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2021

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT04058119

Start Date

February 1 2020

End Date

December 1 2021

Last Update

October 29 2019

Active Locations (1)

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1

Centro de Saúde de Ponta Delgada (Unidade de Saúde da Ilha de São Miguel)

Ponta Delgada, Azores, Portugal, 9500-354