Psychological StressVIVEmindNCT04058119
Mind-Body Therapies in Primary Health Care
A study testing Mind-body therapies in people with Psychological Stress, run by Unidade de Saude da Ilha de Sao Miguel at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Stress
- What is being tested?
- Mind-body therapies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePortugal
- Study dates
- Feb 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Users of Ponta Delgada Health Center with perceived distress (score higher than 20 for men and higher than 22 for women in PSS-10).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Centro de Saúde de Ponta Delgada (Unidade de Saúde da Ilha de São Miguel)
Ponta Delgada, Azores, 9500-354
About this study
Official title: VIVE Mind: Terapias Corpo-mente Nos Cuidados de saúde primários - Estudo Aleatorizado e Controlado
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.
Read the 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.
- Conditions
- Psychological Stress
- Being tested
- Mind-body therapies
- Keywords
- Mind-body therapies, Yoga, Qigong, Pilates, Primary health care
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-body therapiesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mind-body therapies | Experimental | Sessions of body-mind therapies (yoga, qigong and pilates) Receives: Behavioral: Mind-body therapies |
| Waiting list control group | No intervention | Participants will not participate in any specific intervention, but will receive the Functional Training Program after the experimental period (6 months). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Secondary outcomes (19)
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.
Measured: Up to 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).
Measured: Up to 6 months
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.
Measured: Up to 6 months
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).
Measured: T1, Post-intervention (at month 6)
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.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in body mass index (BMI)
Weight (kilograms) and height (meters) will be combined to report BMI in kg/m^2.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in waist circumference
Waist circumference in centimeters.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in body fat
Measured by bioelectrical impedance analysis.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in body lean mass
Measured by bioelectrical impedance analysis.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in systolic and diastolic blood pressure
Resting systolic blood pressure.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in fast blood glycemia
Fast blood glycemia (mg/dL).
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in HbA1c
HbA1c (%) reflects the average plasma glucose over the previous 8 to 12 weeks.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in blood lipid profile
Total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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'.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in analgesic and psychotropic medication dependence
Number of analgesic and psychotropic pills ingested per day.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
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.
Measured: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study startFeb 2020 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unidade de Saude da Ilha de Sao Miguel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara B. Ponte, Unidade de Saude da Ilha de Sao Miguel
- Investigators
- Sara B. Ponte, MD, Principal investigator, Unidade de Saúde da Ilha de São Miguel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058119
- Sponsor's protocol ID
- USISM_02_19
- Acronym
- VIVEmind
- Status last verified
- Oct 2019
- First submitted
- 8 Aug 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIVE Mind: Terapias Corpo-mente Nos Cuidados de saúde primários - Estudo Aleatorizado e Controlado
- ClinicalTrials.gov ID
- NCT04058119
- Acronym / sponsor ID
- VIVEmind / USISM_02_19
- Conditions
- Psychological Stress
- Keywords
- Mind-body therapies, Yoga, Qigong, Pilates, Primary health care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Unidade de Saude da Ilha de Sao MiguelUniversity, hospital or other
- Study start
- Feb 2020 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mind-body therapies | Experimental | Behavioral: Mind-body therapiesSessions of body-mind therapies (yoga, qigong and pilates) |
| Waiting list control group | No intervention | –Participants will not participate in any specific intervention, but will receive the Functional Training Program after the experimental period (6 months). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Users of Ponta Delgada Health Center with perceived distress (score higher than 20 for men and higher than 22 for women in PSS-10).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind-body therapiesSessions 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. | Behavioural | Mind-body therapies |
Primary outcome
Change in perceived stress
Time frame: 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.
19 secondary outcomes
Adherence to the mind-body sessions
Time frame: Up to 6 months
Perceived enjoyment
Time frame: Up to 6 months
Perceived exertion
Time frame: Up to 6 months
Participants' satisfaction
Time frame: T1, Post-intervention (at month 6)
Change in hand grip strength
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in body mass index (BMI)
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in waist circumference
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in body fat
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in body lean mass
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in systolic and diastolic blood pressure
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in fast blood glycemia
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in HbA1c
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in blood lipid profile
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in chronic pain
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in nicotine dependence
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in analgesic and psychotropic medication dependence
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in health-related quality of life
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in psychological distress
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Change in mental well-being
Time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara B. Ponte, MD principal investigator
Unidade de Saúde da Ilha de São Miguel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-body therapies in people with Psychological Stress, run by Unidade de Saude da Ilha de Sao Miguel at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara B. Ponte, MD (+351 296 960 286, Sara.CB.Ponte@azores.gov.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived stress (time frame: T0, baseline; T1, post-intervention (at month 6); and T2, 6-month follow-up (at month 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.