VIVE Mind: Terapias Corpo-mente Nos Cuidados de saúde primários - Estudo Aleatorizado e Controlado
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in perceived stress
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Users of Ponta Delgada Health Center with perceived distress (score higher than 20 for men and higher than 22 for women in PSS-10).
排除标准
- •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.
研究组 & 干预措施
Mind-body therapies
Sessions of body-mind therapies (yoga, qigong and pilates)
干预措施: Mind-body therapies (Behavioral)
Waiting list control group
Participants will not participate in any specific intervention, but will receive the Functional Training Program after the experimental period (6 months).
结局指标
主要结局
Change in perceived stress
时间窗: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Perceived Stress Scale (PSS 10), validated for portuguese population, is a self-report scale with 10 items on daily hassles and the current feeling of being able to handle problems that need to be addressed. It is a five-point Likert scale ranging from 0 (never) to 4 (very often). This questionnaire is widely used to measure perceived stress and has adequate internal and test-retest reliability.
次要结局
- Adherence to the mind-body sessions(Up to 6 months)
- Change in waist circumference(T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12))
- Change in systolic and diastolic blood pressure(T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12))
- Perceived enjoyment(Up to 6 months)
- Perceived exertion(Up to 6 months)
- Participants' satisfaction(T1, Post-intervention (at month 6))
- Change in body lean mass(T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12))
- Change in fast blood glycemia(T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12))
- Change in HbA1c(T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12))
- Change in hand grip strength(T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12))
- Change in body fat(T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12))
- Change in body mass index (BMI)(T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12))
- Change in blood lipid profile(T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12))
- Change in nicotine dependence(T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12))
- Change in health-related quality of life(T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12))
- Change in psychological distress(T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12))
- Change in mental well-being(T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12))
- Change in chronic pain(T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12))
- Change in analgesic and psychotropic medication dependence(T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12))
研究者
Sara B. Ponte
MD, General Practitioner
Unidade de Saude da Ilha de Sao Miguel