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

Primary Purpose

Quality of Life

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Mindfulness meditation
Psychotherapy group
Sponsored by
Centro Mente Aberta de Mindfulness
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Centro Mente Aberta de Mindfulness e Promoção de SaúdeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: Mindfulness group

Psychotherapy group

Arm Description

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.

This group will learn group problem solving techniques during eight weeks

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 14, 2018
Last Updated
April 2, 2020
Sponsor
Centro Mente Aberta de Mindfulness
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1. Study Identification

Unique Protocol Identification Number
NCT03756441
Brief Title
Effects of the MBHP on the Quality of Life of Family Members of People With Intellectual Disability
Acronym
caregivers
Official Title
Effects of the Mindfulness-Based Health Promotion Program (MBHP) on the Quality of Life of Family Members of People With Intellectual Disability
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
February 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Mente Aberta de Mindfulness

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Mindfulness group
Arm Type
Experimental
Arm Description
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.
Arm Title
Psychotherapy group
Arm Type
Active Comparator
Arm Description
This group will learn group problem solving techniques during eight weeks
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness meditation
Intervention Description
This intervention is a meditative practice which the individuals will practive in their daily life following the MBHP protocol
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy group
Intervention Description
Caregivers will learn the technique of group problem solving
Primary Outcome Measure Information:
Title
World Health Organization Quality of Life (WHOQOL-Bref)
Description
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)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Informal Caregiver Overload Assessment Questionnaire (QASCI)
Description
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.
Time Frame
24 months
Title
World Health Organization Disability Assessment Scale (WHODAS)
Description
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.
Time Frame
24 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
In Brazil the number of female caregivers is higher than the male sex
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcelo MP Demarzo, PhD
Phone
+5511533854350
Email
marcelodemarzo@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Leticia S Oliveira
Phone
+5511996482687
Email
leticiasouza.psi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo MP Demarzo, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Mente Aberta de Mindfulness e Promoção de Saúde
City
São Paulo
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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