Back to resultsMind-Body Therapies in Primary Health Care (VIVEmind)
Primary Purpose
Psychological Stress
Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Mind-body therapies
Sponsored by
About this trial
This is an interventional prevention trial for Psychological Stress focused on measuring Mind-body therapies, Yoga, Qigong, Pilates, Primary health care
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.
Sites / Locations
- Centro de Saúde de Ponta Delgada (Unidade de Saúde da Ilha de São Miguel)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mind-body therapies
Waiting list control group
Arm Description
Sessions of body-mind therapies (yoga, qigong and pilates)
Participants will not participate in any specific intervention, but will receive the Functional Training Program after the experimental period (6 months).
Outcomes
Primary Outcome Measures
Change in perceived stress
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.
Secondary Outcome Measures
Adherence to the mind-body sessions
Proportion of adherence to the mind-body sessions will be calculated by the average of adherence of each participant. The adherence of each participant will be quantified by the relationship between the sessions attended and the total number of sessions scheduled over the 6 months.
Perceived enjoyment
Perceived enjoyment of the mind-body sessions will be measured biweekly by a scale rated from 1 (very unpleasant) to 5 (very enjoyable).
Perceived exertion
Perception exertion of mind-body sessions will be measured biweekly by the modified Borg scale. In this instrument, 11 items are evaluated, with a score of 0 to 10 points, where 0 equals the minimum effort and 10 the maximum that they can perform.
Participants' satisfaction
Participant's satisfaction levels will be measured by 10-items questionnaire, on a five point Likert scale from 1 (displeased) to 5 (very satisfied).
Change in hand grip strength
Hand grip strength will be evaluated while the participant is in a sitting position with shoulders adducted and neutrally rotated, elbow flexed at 90°, forearm in neutral and wrist between 0 and 30° of extension. The test will be repeated 3 times with the dominant hand, and maximum reading will be taken.
Change in body mass index (BMI)
Weight (kilograms) and height (meters) will be combined to report BMI in kg/m^2.
Change in waist circumference
Waist circumference in centimeters.
Change in body fat
Measured by bioelectrical impedance analysis.
Change in body lean mass
Measured by bioelectrical impedance analysis.
Change in systolic and diastolic blood pressure
Resting systolic blood pressure.
Change in fast blood glycemia
Fast blood glycemia (mg/dL).
Change in HbA1c
HbA1c (%) reflects the average plasma glucose over the previous 8 to 12 weeks.
Change in blood lipid profile
Total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides.
Change in chronic pain
Brief Pain Inventory (BPI) will assess the average pain at rest, using a numerical (0-10) rating scale on the BPI Short Form. A higher score indicates worse pain (10 is "worst pain imaginable") and zero indicates 'no pain at all'.
Change in nicotine dependence
Fagerström Test for Nicotine Dependence (FTND) will be applied only in smokers participants.
FTND is a 6-item self-report measure of nicotine dependence derived from the Fagerström Tolerance Questionnaire, which comprises yes/no options (scored from 0 to 1) and multiple-choice items (scored from 0 to 3). The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.
Change in analgesic and psychotropic medication dependence
Number of analgesic and psychotropic pills ingested per day.
Change in health-related quality of life
The health-related quality of life questionaire EQ-5D-5L is a standardised self-report measure of health status developed by the EuroQol Group. It consists of the descriptive system and the EQ Visual Analogue scale. The descriptive system comprises 5 dimensions, namely mobility, self care, usual activities, pain/discomfort, anxiety/depression.
Change in psychological distress
Depression, anxiety stress scale-21 (DASS-21) consists of three 7-item subscales: depression, anxiety, and stress. Participants indicate how much each of 21 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). This scale has good psychometric properties in both clinical and non-clinical samples. Also, this scale reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation) and depression (low mood/anhedonia), which are highly comorbid.
Change in mental well-being
Warwick-Edinburgh Mental Well-being Scale (WEMWBS) is a 14-item scale, validated and self-report instrument used to assess mental wellbeing in general population. Possible scores range from range from 14-70, with higher scores indicating higher mental well-being.
Full Information
NCT ID
NCT04058119
First Posted
August 8, 2019
Last Updated
October 25, 2019
Sponsor
Unidade de Saude da Ilha de Sao Miguel
1. Study Identification
Unique Protocol Identification Number
NCT04058119
Brief Title
Mind-Body Therapies in Primary Health Care
Acronym
VIVEmind
Official Title
VIVE Mind: Terapias Corpo-mente Nos Cuidados de saúde primários - Estudo Aleatorizado e Controlado
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2020 (Anticipated)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Unidade de Saude da Ilha de Sao Miguel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress
Keywords
Mind-body therapies, Yoga, Qigong, Pilates, Primary health care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mind-body therapies
Arm Type
Experimental
Arm Description
Sessions of body-mind therapies (yoga, qigong and pilates)
Arm Title
Waiting list control group
Arm Type
No Intervention
Arm Description
Participants will not participate in any specific intervention, but will receive the Functional Training Program after the experimental period (6 months).
Intervention Type
Behavioral
Intervention Name(s)
Mind-body therapies
Intervention Description
Sessions of body-mind therapies (yoga, qigong and pilates), oriented by certified instructors. Every sessions will be 60-minutes long, biweekly, with a total duration of 6 months.
Primary Outcome Measure Information:
Title
Change in perceived stress
Description
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.
Time Frame
T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Secondary Outcome Measure Information:
Title
Adherence to the mind-body sessions
Description
Proportion of adherence to the mind-body sessions will be calculated by the average of adherence of each participant. The adherence of each participant will be quantified by the relationship between the sessions attended and the total number of sessions scheduled over the 6 months.
Time Frame
Up to 6 months
Title
Perceived enjoyment
Description
Perceived enjoyment of the mind-body sessions will be measured biweekly by a scale rated from 1 (very unpleasant) to 5 (very enjoyable).
Time Frame
Up to 6 months
Title
Perceived exertion
Description
Perception exertion of mind-body sessions will be measured biweekly by the modified Borg scale. In this instrument, 11 items are evaluated, with a score of 0 to 10 points, where 0 equals the minimum effort and 10 the maximum that they can perform.
Time Frame
Up to 6 months
Title
Participants' satisfaction
Description
Participant's satisfaction levels will be measured by 10-items questionnaire, on a five point Likert scale from 1 (displeased) to 5 (very satisfied).
Time Frame
T1, Post-intervention (at month 6)
Title
Change in hand grip strength
Description
Hand grip strength will be evaluated while the participant is in a sitting position with shoulders adducted and neutrally rotated, elbow flexed at 90°, forearm in neutral and wrist between 0 and 30° of extension. The test will be repeated 3 times with the dominant hand, and maximum reading will be taken.
Time Frame
T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Title
Change in body mass index (BMI)
Description
Weight (kilograms) and height (meters) will be combined to report BMI in kg/m^2.
Time Frame
T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Title
Change in waist circumference
Description
Waist circumference in centimeters.
Time Frame
T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Title
Change in body fat
Description
Measured by bioelectrical impedance analysis.
Time Frame
T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Title
Change in body lean mass
Description
Measured by bioelectrical impedance analysis.
Time Frame
T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Title
Change in systolic and diastolic blood pressure
Description
Resting systolic blood pressure.
Time Frame
T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Title
Change in fast blood glycemia
Description
Fast blood glycemia (mg/dL).
Time Frame
T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Title
Change in HbA1c
Description
HbA1c (%) reflects the average plasma glucose over the previous 8 to 12 weeks.
Time Frame
T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Title
Change in blood lipid profile
Description
Total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides.
Time Frame
T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Title
Change in chronic pain
Description
Brief Pain Inventory (BPI) will assess the average pain at rest, using a numerical (0-10) rating scale on the BPI Short Form. A higher score indicates worse pain (10 is "worst pain imaginable") and zero indicates 'no pain at all'.
Time Frame
T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Title
Change in nicotine dependence
Description
Fagerström Test for Nicotine Dependence (FTND) will be applied only in smokers participants.
FTND is a 6-item self-report measure of nicotine dependence derived from the Fagerström Tolerance Questionnaire, which comprises yes/no options (scored from 0 to 1) and multiple-choice items (scored from 0 to 3). The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.
Time Frame
T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Title
Change in analgesic and psychotropic medication dependence
Description
Number of analgesic and psychotropic pills ingested per day.
Time Frame
T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Title
Change in health-related quality of life
Description
The health-related quality of life questionaire EQ-5D-5L is a standardised self-report measure of health status developed by the EuroQol Group. It consists of the descriptive system and the EQ Visual Analogue scale. The descriptive system comprises 5 dimensions, namely mobility, self care, usual activities, pain/discomfort, anxiety/depression.
Time Frame
T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Title
Change in psychological distress
Description
Depression, anxiety stress scale-21 (DASS-21) consists of three 7-item subscales: depression, anxiety, and stress. Participants indicate how much each of 21 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). This scale has good psychometric properties in both clinical and non-clinical samples. Also, this scale reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation) and depression (low mood/anhedonia), which are highly comorbid.
Time Frame
T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Title
Change in mental well-being
Description
Warwick-Edinburgh Mental Well-being Scale (WEMWBS) is a 14-item scale, validated and self-report instrument used to assess mental wellbeing in general population. Possible scores range from range from 14-70, with higher scores indicating higher mental well-being.
Time Frame
T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara B. Ponte, MD
Phone
+351 296 960 286
Email
Sara.CB.Ponte@azores.gov.pt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara B. Ponte, MD
Organizational Affiliation
Unidade de Saúde da Ilha de São Miguel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Saúde de Ponta Delgada (Unidade de Saúde da Ilha de São Miguel)
City
Ponta Delgada
State/Province
Azores
ZIP/Postal Code
9500-354
Country
Portugal
12. IPD Sharing Statement
Learn more about this trial
Mind-Body Therapies in Primary Health Care
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