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

Quality of Life Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03756441
• Other study ID #: 81973417.8.0000.5505
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: February 1, 2022

Study information

• Verified date: April 2020
• Source: Centro Mente Aberta de Mindfulness
• Contact: Marcelo MP Demarzo, PhD
• Phone: +5511533854350
• Email: marcelodemarzo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: February 1, 2022
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intellectual Disability
• Quality of Life

Intervention

Behavioral:
• Mindfulness meditation
This intervention is a meditative practice which the individuals will practive in their daily life following the MBHP protocol
• Psychotherapy group
Caregivers will learn the technique of group problem solving

Locations

Country	Name	City	State
Brazil	Centro Mente Aberta de Mindfulness e Promoção de Saúde	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Centro Mente Aberta de Mindfulness

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	24 months
Secondary	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.	24 months
Secondary	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.	24 months