Effects of the MBHP on the Quality of Life of Family Members of People With Intellectual Disability (caregivers)

April 2, 2020 updated by: Marcelo Demarzo, MD, PhD, Centro Mente Aberta de Mindfulness

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
154

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil
        • Recruiting
        • Centro Mente Aberta de Mindfulness e Promoção de Saúde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Above 18 years
  • Being a mother with SASE DI
  • Be in accordance with the Informed Consent Form

Exclusion Criteria:

  • Under 18 years
  • Acute psychiatric problem
  • Regular practice of mindfulness or meditation in the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: Mindfulness group
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.
Behavioral: Mindfulness meditation
This intervention is a meditative practice which the individuals will practive in their daily life following the MBHP protocol
Active Comparator: Psychotherapy group
This group will learn group problem solving techniques during eight weeks
Behavioral: Psychotherapy group
Caregivers will learn the technique of group problem solving

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Informal Caregiver Overload Assessment Questionnaire (QASCI)
Time Frame: 24 months
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.
24 months
World Health Organization Disability Assessment Scale (WHODAS)
Time Frame: 24 months
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centro Mente Aberta de Mindfulness

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 81973417.8.0000.5505

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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