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

C

Centro Mente Aberta de Mindfulness

Status

Unknown

Conditions

Quality of Life

Treatments

Behavioral: Psychotherapy group
Behavioral: Mindfulness meditation

Study type

Interventional

Funder types

Other

Identifiers

NCT03756441
81973417.8.0000.5505

Details and patient eligibility

About

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.

Full 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.

Enrollment

154 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

154 participants in 2 patient groups

Experimental: Mindfulness group
Experimental group
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.
Treatment:
Behavioral: Mindfulness meditation
Psychotherapy group
Active Comparator group
Description:
This group will learn group problem solving techniques during eight weeks
Treatment:
Behavioral: Psychotherapy group

Trial contacts and locations

1

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Central trial contact

Leticia S Oliveira; Marcelo MP Demarzo, PhD

Data sourced from clinicaltrials.gov

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