Clinical trial NCT03756441: Effects of the MBHP on the Quality of Life of Family Members of People With Intellectual Disability
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
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Lead sponsor: Centro Mente Aberta de Mindfulness
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 154
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: World Health Organization Quality of Life (WHOQOL-Bref)
timeFrame: 24 months
Secondary outcomes:
measure: Informal Caregiver Overload Assessment Questionnaire (QASCI)
timeFrame: 24 months
measure: World Health Organization Disability Assessment Scale (WHODAS)
timeFrame: 24 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Centro Mente Aberta de Mindfulness e Promoção de Saúde
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Marcelo MP Demarzo, PhD
role: PRINCIPAL_INVESTIGATOR
References: