Clinical trial NCT04058119: Mind-Body Therapies in Primary Health Care
Official title: VIVE Mind: Terapias Corpo-mente Nos Cuidados de saúde primários - Estudo Aleatorizado e Controlado
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychological Stress
Keywords: Mind-body therapies
Yoga
Qigong
Pilates
Primary health care
Lead sponsor: Unidade de Saude da Ilha de Sao Miguel
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 should encourage the implementation of complementary interventions for prevention of this type of disorders. New approaches, such as mind-body therapies, have been studied and recommended for prevention and treatment of numerous chronic diseases, particularly mental disorders.

This study aims to evaluate the feasibility and effectiveness of a 6-months mind-body therapies (yoga, qigong and pilates), in users of Ponta Delgada Health Center (PDHC) with perceived distress, compared to a waiting list control.

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 experimental and waiting list control group, in a 1:1 ratio. The recruitment of participants will be held in PDHC by health professional (e.g., family medicine doctors, nurses, nutritionists, psychologists, etc). After signed informed consent and baseline measures, experimental group will participate in body-mind sessions (yoga, qigong or pilates), oriented by certified instructors, during 6-months. Each participant should attend only one of the therapies, in order to guarantee a differentiated evaluation. In every session, it will be evaluated the participants' adherence and theirs perceived enjoyment and exertion. The other outcomes (primary and secondary) will be analyzed through a face-to-face contact, in three different moments: baseline (T0), post-intervention (at month 6, T1) and 6-month follow-up (at month 12, T2). The control group will not participate in any specific intervention, but will receive the body-mind intervention after the experimental period. An intention-to-treat and per protocol analysis will be performed to analyze intervention effectiveness and efficacy.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change in perceived stress
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Secondary outcomes:
measure: Adherence to the mind-body sessions
timeFrame: Up to 6 months
measure: Perceived enjoyment
timeFrame: Up to 6 months
measure: Perceived exertion
timeFrame: Up to 6 months
measure: Participants' satisfaction
timeFrame: T1, Post-intervention (at month 6)
measure: Change in hand grip strength
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in body mass index (BMI)
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in waist circumference
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in body fat
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in body lean mass
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in systolic and diastolic blood pressure
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in fast blood glycemia
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in HbA1c
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in blood lipid profile
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in chronic pain
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in nicotine dependence
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in analgesic and psychotropic medication dependence
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in health-related quality of life
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in psychological distress
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
measure: Change in mental well-being
timeFrame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Other outcomes:
Locations:
city: Ponta Delgada
country: Portugal
facility: Centro de Saúde de Ponta Delgada (Unidade de Saúde da Ilha de São Miguel)
state: Azores
Study officials:
affiliation: Unidade de Saúde da Ilha de São Miguel
name: Sara B. Ponte, MD
role: PRINCIPAL_INVESTIGATOR
References: