NCT03756441

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
154

participants targeted

Target at P75+ for not_applicable quality-of-life

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

28 days

First QC Date

November 14, 2018

Last Update Submit

April 2, 2020

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Informal Caregiver Overload Assessment Questionnaire (QASCI)

    24 months

  • World Health Organization Disability Assessment Scale (WHODAS)

    24 months

Study Arms (2)

Experimental: Mindfulness group

EXPERIMENTAL

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.

Behavioral: Mindfulness meditation

Psychotherapy group

ACTIVE COMPARATOR

This group will learn group problem solving techniques during eight weeks

Behavioral: Psychotherapy group

Interventions

Mindfulness meditationBEHAVIORAL

This intervention is a meditative practice which the individuals will practive in their daily life following the MBHP protocol

Experimental: Mindfulness group
Psychotherapy groupBEHAVIORAL

Caregivers will learn the technique of group problem solving

Psychotherapy group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIn Brazil the number of female caregivers is higher than the male sex
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Above 18 years
  • Being a mother with SASE DI
  • Be in accordance with the Informed Consent Form

You may not qualify if:

  • Under 18 years
  • Acute psychiatric problem
  • Regular practice of mindfulness or meditation in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Mente Aberta de Mindfulness e Promoção de Saúde

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Interventions

MindfulnessPsychotherapy, Group

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesSocioenvironmental Therapy

Study Officials

  • Marcelo MP Demarzo, PhD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcelo MP Demarzo, PhD

CONTACT

+5511533854350marcelodemarzo@gmail.com

Leticia S Oliveira

CONTACT

+5511996482687leticiasouza.psi@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 28, 2018

Study Start

February 1, 2019

Primary Completion

March 1, 2019

Study Completion

February 1, 2022

Last Updated

April 6, 2020

Record last verified: 2020-04

Locations

BR(1)