<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03756441</url>
  </required_header>
  <id_info>
    <org_study_id>81973417.8.0000.5505</org_study_id>
    <nct_id>NCT03756441</nct_id>
  </id_info>
  <brief_title>Effects of the MBHP on the Quality of Life of Family Members of People With Intellectual Disability</brief_title>
  <acronym>caregivers</acronym>
  <official_title>Effects of the Mindfulness-Based Health Promotion Program (MBHP) on the Quality of Life of Family Members of People With Intellectual Disability</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro Mente Aberta de Mindfulness</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centro Mente Aberta de Mindfulness</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The research aims to verify the effects of the Mindfulness Based Health Promotion (PSBM)&#xD;
      program on the quality of life of mothers of person with intellectual disability. Method: A&#xD;
      randomized, controlled study with pre-post intervention measures and a follow-up measurement&#xD;
      will be performed after six months of the end of the intervention. Sample: It will be&#xD;
      composed of mothers of the 209 attended with moderate intellectual disability, adolescents&#xD;
      and adults of the Service of Socioeducation of the Association of Parents and Friends of the&#xD;
      Exceptional (APAE) of São Paulo, excluding those who have any psychiatric problem in the&#xD;
      acute phase and minors, or who have regular practice of mindfulness or meditation in the last&#xD;
      6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Outcomes and Instruments to be used: As primary endpoint the quality of life of the family&#xD;
      caregiver will be observed and as a secondary outcome the caregiver's overload will be&#xD;
      observed. As explanatory variables will be considered anxiety, depression, functionality and&#xD;
      level of attention to the present moment (mindfulness). The investigators will use focal&#xD;
      group, Sociodemographic questionnaire, World Health Organization Disability Assessment Scale,&#xD;
      Hospital Anxiety and Depression Scale, Brief Autocompaction Scale, World Health Organization&#xD;
      Quality of Life Scale Brief Version, Mindful Attention Awareness Scale, Qualitative Analysis&#xD;
      Questionnaire - Semi-Structured, Informal Caregiver Burden Assessment Questionnaire, Number&#xD;
      of Practices and Adverse Effects. Procedure: The mothers of people with intellectual&#xD;
      disability (ID) will be invited to participate in the research protocol. Having knowledge of&#xD;
      the subject, agreeing to participate and signing the consent form, will respond to the&#xD;
      questionnaires identified above, with a total duration of approximately 1 hour and 30&#xD;
      minutes. Subsequently the participants will be randomized into two groups, in which one will&#xD;
      receive the mindfulness intervention and the other, active control, will participate in a&#xD;
      Problem Solving Training. The protocols of questionnaires and focal group will be performed&#xD;
      before, immediately after the accomplishment of the groups and in the follow-up of six&#xD;
      months. The intervention group will last 8 weeks, according to the Mindfulness Based Health&#xD;
      Promotion Program (PSBM) and during this same period the active control group will occur.&#xD;
      Hypotheses and expected results: Mindfulness is expected to contribute to the improvement of&#xD;
      the quality of life of this population, and so the investigators can contribute to the&#xD;
      scientific increase in the theme.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">February 1, 2022</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>World Health Organization Quality of Life (WHOQOL-Bref)</measure>
    <time_frame>24 months</time_frame>
    <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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Informal Caregiver Overload Assessment Questionnaire (QASCI)</measure>
    <time_frame>24 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>World Health Organization Disability Assessment Scale (WHODAS)</measure>
    <time_frame>24 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">154</enrollment>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Experimental: Mindfulness group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Psychotherapy group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will learn group problem solving techniques during eight weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness meditation</intervention_name>
    <description>This intervention is a meditative practice which the individuals will practive in their daily life following the MBHP protocol</description>
    <arm_group_label>Experimental: Mindfulness group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychotherapy group</intervention_name>
    <description>Caregivers will learn the technique of group problem solving</description>
    <arm_group_label>Psychotherapy group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Above 18 years&#xD;
&#xD;
          -  Being a mother with SASE DI&#xD;
&#xD;
          -  Be in accordance with the Informed Consent Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years&#xD;
&#xD;
          -  Acute psychiatric problem&#xD;
&#xD;
          -  Regular practice of mindfulness or meditation in the last 6 months&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>In Brazil the number of female caregivers is higher than the male sex</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcelo MP Demarzo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of São Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marcelo MP Demarzo, PhD</last_name>
    <phone>+5511533854350</phone>
    <email>marcelodemarzo@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Leticia S Oliveira</last_name>
    <phone>+5511996482687</phone>
    <email>leticiasouza.psi@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centro Mente Aberta de Mindfulness e Promoção de Saúde</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>April 2, 2020</last_update_submitted>
  <last_update_submitted_qc>April 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centro Mente Aberta de Mindfulness</investigator_affiliation>
    <investigator_full_name>Marcelo Demarzo, MD, PhD</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intellectual Disability</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03756441
org study id: 81973417.8.0000.5505
nct id: NCT03756441
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: World Health Organization Quality of Life (WHOQOL-Bref)
time frame: 24 months
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)
measure: Informal Caregiver Overload Assessment Questionnaire (QASCI)
time frame: 24 months
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.
measure: World Health Organization Disability Assessment Scale (WHODAS)
time frame: 24 months
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.
arm group label: Experimental: Mindfulness group
arm group type: Experimental
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 group label: Psychotherapy group
arm group type: Active Comparator
description: This group will learn group problem solving techniques during eight weeks
intervention type: Behavioral
intervention name: Mindfulness meditation
description: This intervention is a meditative practice which the individuals will practive in their daily life following the MBHP protocol
arm group label: Experimental: Mindfulness group
intervention type: Behavioral
intervention name: Psychotherapy group
description: Caregivers will learn the technique of group problem solving
arm group label: Psychotherapy group
criteria: 
gender: Female
gender based: Yes
gender description: In Brazil the number of female caregivers is higher than the male sex
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marcelo MP Demarzo, PhD
role: Principal Investigator
affiliation: Federal University of São Paulo
last name: Marcelo MP Demarzo, PhD
phone: +5511533854350
email: marcelodemarzo@gmail.com
last name: Leticia S Oliveira
phone: +5511996482687
email: leticiasouza.psi@gmail.com
facility: 
status: Recruiting
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Centro Mente Aberta de Mindfulness
investigator full name: Marcelo Demarzo, MD, PhD
investigator title: PhD
mesh term: Intellectual Disability