Mindfulness for Alzheimer Caregivers

NCT ID: NCT03858283

Last Updated: 2022-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-02

Study Completion Date

2020-03-13

Brief Summary

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Mindfulness Based Health Care (MBHC) includes meditation techniques to help caregivers of Alzheimer patients to be made more aware of their experience in the present moment. Half of the caregivers will learn the practice of mindfulness meditation once a week through 8 classes, and the other half will not receive any therapy. The primary purpose of this study is to explore the effects of this mindfulness program for caregivers on the neuropsychiatric symptoms in Alzheimer patients, as well as on anxiety and depression symptoms in their caregivers. Secondarily, to examine the effect of this program on cognitive function, daily activity living and quality of life in Alzheimer patients, as well as on the burden of caregiving, quality of life, psychological well-being, occupational balance, executive function and self-compassion in their caregivers.

Detailed Description

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Alzheimer's disease is a progressive brain disorder that involves the loss of the ability to live independently, functional capacity and safety. Thus, patients often suffer neuropsychiatric disorders and need help from another person to live every day. Due to the burden of caregiving, the main caregivers can have anxiety and depression symptoms. With this scenario, we will conduct this randomized controlled trial aimed to evaluate the effect of mindfulness program for caregiver's vs control group on: 1) neuropsychiatric disorders, cognitive function, daily activity living and quality of life in Alzheimer patients; 2) anxiety and depression symptoms, burden of caregiving, quality of life, psychological well-being, occupational balance, executive function and self-compassion in their caregivers.

Conditions

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Alzheimer Disease Neurodegenerative Diseases Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Mindfulness Based Health Care Program

Group Type EXPERIMENTAL

Mindfulness Based Health Care (MBHC) Program

Intervention Type BEHAVIORAL

Mindfulness Based Health Care (MBHC) Program for Caregivers of Alzheimer's Disease Patients. The duration of this group was 8 weeks. The program included one session per week, with each session lasting 1 hour and 30 minutes

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness Based Health Care (MBHC) Program

Mindfulness Based Health Care (MBHC) Program for Caregivers of Alzheimer's Disease Patients. The duration of this group was 8 weeks. The program included one session per week, with each session lasting 1 hour and 30 minutes

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* be a caregiver of Alzheimer disease patient
* age over 18 years
* Score Mini Mental State Examination ≥26 points


* Score of Scale Global Deterioration from 3 to 7 points (inclusive)
* Alzheimer disease diagnostic
* Non-institutionalized

Exclusion Criteria

* Patient or caregivers with central nervous system disease with a neurological alteration (acquired brain damage, epilepsy, traumatic brain injury, multiple sclerosis and other movement disorders).
* Patient or caregivers with current or past history of alcohol or drug abuse
* Patient or caregivers with visual or hearing impairment
* Patient or caregivers with serious psychiatric illness (depression, psychosis, schizophrenia)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role lead

Responsible Party

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ALICIA SANCHEZ PEREZ

Principal Investigator. Director of the Master's Degree in Occupational Therapy in Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alicia Sánchez Pérez

Sant Joan d'Alacant, Alicante, Spain

Site Status

Countries

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Spain

Other Identifiers

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Mind01UMH

Identifier Type: -

Identifier Source: org_study_id

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