Quality of LifecaregiversNCT03756441
Effects of the MBHP on the Quality of Life of Family Members of People With Intellectual Disability
A study testing Mindfulness meditation and Psychotherapy group in people with Quality of Life, run by Centro Mente Aberta de Mindfulness at 1 site in Brazil.
Trial summary
The research aims to verify the effects of the Mindfulness Based Health Promotion (PSBM) program on the quality of life of mothers of person with intellectual disability. Method: A randomized, controlled study with pre-post intervention measures and a follow-up measurement will be performed after six months of the end… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- Mindfulness meditation and Psychotherapy group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2019to 1 Feb 2022
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above 18 years
- Being a mother with SASE DI
- Be in accordance with the Informed Consent Form
Who cannot join
- Under 18 years
- Acute psychiatric problem
- Regular practice of mindfulness or meditation in the last 6 months
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Centro Mente Aberta de Mindfulness e Promoção de Saúde
São Paulo, São Paulo
About this study
Official title: Effects of the Mindfulness-Based Health Promotion Program (MBHP) on the Quality of Life of Family Members of People With Intellectual Disability
The research aims to verify the effects of the Mindfulness Based Health Promotion (PSBM) program on the quality of life of mothers of person with intellectual disability. Method: A randomized, controlled study with pre-post intervention measures and a follow-up measurement will be performed after six months of the end of the intervention. Sample: It will be composed of mothers of the 209 attended with moderate intellectual disability, adolescents and adults of the Service of Socioeducation of the Association of Parents and Friends of the Exceptional (APAE) of São Paulo, excluding those who have any psychiatric problem in the acute phase and minors, or who have regular practice of mindfulness or meditation in the last 6 months.
Read the detailed description
Outcomes and Instruments to be used: As primary endpoint the quality of life of the family caregiver will be observed and as a secondary outcome the caregiver's overload will be observed. As explanatory variables will be considered anxiety, depression, functionality and level of attention to the present moment (mindfulness). The investigators will use focal group, Sociodemographic questionnaire, World Health Organization Disability Assessment Scale, Hospital Anxiety and Depression Scale, Brief Autocompaction Scale, World Health Organization Quality of Life Scale Brief Version, Mindful Attention Awareness Scale, Qualitative Analysis Questionnaire - Semi-Structured, Informal Caregiver Burden Assessment Questionnaire, Number of Practices and Adverse Effects. Procedure: The mothers of people with intellectual disability (ID) will be invited to participate in the research protocol. Having knowledge of the subject, agreeing to participate and signing the consent form, will respond to the questionnaires identified above, with a total duration of approximately 1 hour and 30 minutes. Subsequently the participants will be randomized into two groups, in which one will receive the mindfulness intervention and the other, active control, will participate in a Problem Solving Training. The protocols of questionnaires and focal group will be performed before, immediately after the accomplishment of the groups and in the follow-up of six months. The intervention group will last 8 weeks, according to the Mindfulness Based Health Promotion Program (PSBM) and during this same period the active control group will occur. Hypotheses and expected results: Mindfulness is expected to contribute to the improvement of the quality of life of this population, and so the investigators can contribute to the scientific increase in the theme.
- Conditions
- Quality of Life
- Being tested
- Mindfulness meditation, Psychotherapy group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditationBehavioural
This intervention is a meditative practice which the individuals will practive in their daily life following the MBHP protocol
Psychotherapy groupBehavioural
Caregivers will learn the technique of group problem solving
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Mindfulness group | Experimental | This group will be included in the eight-week mindfulness program following the Mindfulness-Based Health Promotion protocol. They will group with have eight meetings, one per week, during a half hour and will learn the techiques to practice everyday during the week. Receives: Behavioral: Mindfulness meditation |
| Psychotherapy group | Active comparator | This group will learn group problem solving techniques during eight weeks Receives: Behavioral: Psychotherapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization Quality of Life (WHOQOL-Bref)
Assess the impact of a Mindfulness-Based Health Promotion (MBHP) program on the quality of life by the WHOQOL-Bref of the family caregiver. Generic instrument of evaluation of the perception of the quality of life created by the World Health Organization (WHO). Abbreviated version, with 26 items grouped into 4 domains: physical, psychological, social and environmental health overall quality of life, and assessments by means of the average according to the quantity of issues in each domain. The results are presented according to the following score: 1-2,9 (good improvement), 3 -3,9 (regular), 4-4,9 (good), 5 (very good)
Measured: 24 months
Secondary outcomes (2)
Informal Caregiver Overload Assessment Questionnaire (QASCI)
Assess the Impact of a Mindfulness-Based Health Promotion Program on Overload of the caregiver. Questionnaire with 32 questions, developed in Portugal, adapted and validated for Brazil, was designed to measure the physical, emotional and social development of the informal caregiver with stroke, later used for informal caregivers of the elderly and dependent persons in at least one activity of daily living.
Measured: 24 months
World Health Organization Disability Assessment Scale (WHODAS)
Assess the Impact of a Mindfulness-Based Health Promotion Program on Functionality of the caregiver. Designed to assess the level of functionality in six life domains (cognition, mobility, self-care, social coexistence, life activities and participation society), this scale covers the fields of International Classification of Functionality (CIF). The short version of 12 items will be used, translated and adapted to the Portuguese. The 'interviewer-administered' version will be used.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start1 Feb 2019
- Primary completion1 Mar 2019
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Mente Aberta de Mindfulness
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo Demarzo, MD, PhD, Centro Mente Aberta de Mindfulness
- Investigators
- Marcelo MP Demarzo, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756441
- Sponsor's protocol ID
- 81973417.8.0000.5505
- Acronym
- caregivers
- Status last verified
- Apr 2020
- First submitted
- 14 Nov 2018
- Last updated
- 6 Apr 2020
- 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 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Mindfulness-Based Health Promotion Program (MBHP) on the Quality of Life of Family Members of People With Intellectual Disability
- ClinicalTrials.gov ID
- NCT03756441
- Acronym / sponsor ID
- caregivers / 81973417.8.0000.5505
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Centro Mente Aberta de MindfulnessUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 28 Nov 2018 (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.
The research aims to verify the effects of the Mindfulness Based Health Promotion (PSBM) program on the quality of life of mothers of person with intellectual disability. Method: A randomized, controlled study with pre-post intervention measures and a follow-up measurement will be performed after six months of the end of the intervention. Sample: It will be composed of mothers of the 209 attended with moderate intellectual disability, adolescents and adults of the Service of Socioeducation of the Association of Parents and Friends of the Exceptional (APAE) of São Paulo, excluding those who have any psychiatric problem in the acute phase and minors, or who have regular practice of mindfulness or meditation in the last 6 months.
Detailed description
Outcomes and Instruments to be used: As primary endpoint the quality of life of the family caregiver will be observed and as a secondary outcome the caregiver's overload will be observed. As explanatory variables will be considered anxiety, depression, functionality and level of attention to the present moment (mindfulness). The investigators will use focal group, Sociodemographic questionnaire, World Health Organization Disability Assessment Scale, Hospital Anxiety and Depression Scale, Brief Autocompaction Scale, World Health Organization Quality of Life Scale Brief Version, Mindful Attention Awareness Scale, Qualitative Analysis Questionnaire - Semi-Structured, Informal Caregiver Burden Assessment Questionnaire, Number of Practices and Adverse Effects. Procedure: The mothers of people with intellectual disability (ID) will be invited to participate in the research protocol. Having knowledge of the subject, agreeing to participate and signing the consent form, will respond to the questionnaires identified above, with a total duration of approximately 1 hour and 30 minutes. Subsequently the participants will be randomized into two groups, in which one will receive the mindfulness intervention and the other, active control, will participate in a Problem Solving Training. The protocols of questionnaires and focal group will be performed before, immediately after the accomplishment of the groups and in the follow-up of six months. The intervention group will last 8 weeks, according to the Mindfulness Based Health Promotion Program (PSBM) and during this same period the active control group will occur. Hypotheses and expected results: Mindfulness is expected to contribute to the improvement of the quality of life of this population, and so the investigators can contribute to the scientific increase in the theme.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Mindfulness group | Experimental | Behavioral: Mindfulness meditationThis group will be included in the eight-week mindfulness program following the Mindfulness-Based Health Promotion protocol. They will group with have eight meetings, one per week, during a half hour and will learn the techiques to practice everyday during the week. |
| Psychotherapy group | Active comparator | Behavioral: Psychotherapy groupThis group will learn group problem solving techniques during eight weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Above 18 years
- Being a mother with SASE DI
- Be in accordance with the Informed Consent Form
Key exclusion criteria (3 listed)
- Under 18 years
- Acute psychiatric problem
- Regular practice of mindfulness or meditation in the last 6 months
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 |
|---|---|---|
| Mindfulness meditationThis intervention is a meditative practice which the individuals will practive in their daily life following the MBHP protocol | Behavioural | Experimental: Mindfulness group |
| Psychotherapy groupCaregivers will learn the technique of group problem solving | Behavioural | Psychotherapy group |
Primary outcome
World Health Organization Quality of Life (WHOQOL-Bref)
Time frame: 24 months
Assess the impact of a Mindfulness-Based Health Promotion (MBHP) program on the quality of life by the WHOQOL-Bref of the family caregiver. Generic instrument of evaluation of the perception of the quality of life created by the World Health Organization (WHO). Abbreviated version, with 26 items grouped into 4 domains: physical, psychological, social and environmental health overall quality of life, and assessments by means of the average according to the quantity of issues in each domain. The results are presented according to the following score: 1-2,9 (good improvement), 3 -3,9 (regular), 4-4,9 (good), 5 (very good)
2 secondary outcomes
Informal Caregiver Overload Assessment Questionnaire (QASCI)
Time frame: 24 months
World Health Organization Disability Assessment Scale (WHODAS)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
Related trials for Quality of Life
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
Marcelo MP Demarzo, PhD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness meditation and Psychotherapy group in people with Quality of Life, run by Centro Mente Aberta de Mindfulness at 1 site in Brazil.
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 3 inclusion and 3 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 6 Apr 2020. 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 Brazil. 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 Marcelo MP Demarzo, PhD (+5511533854350, marcelodemarzo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organization Quality of Life (WHOQOL-Bref) (time frame: 24 months). 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 6 Apr 2020.