Clinical trial NCT03858283: Mindfulness for Alzheimer Caregivers
Official title: Mindfulness Based Health Care (MBHC) Program for Caregivers in the Neuropsychiatric Disorders in Alzheimer Patients and Anxiety and Depression in Caregivers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimer Disease
Neurodegenerative Diseases
Dementia
Keywords: Mindfulness
Anxiety and depression symptoms
Caregivers
Alzheimer
neuropsychiatric disorders
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria of Caregivers:

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

Inclusion Criteria of Patients:

* 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)

Primary outcomes:
measure: Changes in Neuropsychiatric disorders of Alzheimer patients measured with Neuropsychiatric inventory
timeFrame: baseline, 8 weeks, 3 months after the 8 weeks
measure: Changes in Anxiety and depression symptoms in Caregivers of Alzheimer patients measured with Hospital Anxiety and Depression scale
timeFrame: baseline, 8 weeks, 3 months after the 8 weeks
Secondary outcomes:
measure: Changes in Cognitive Function of Alzheimer patients with Mini Mental State Examination
timeFrame: baseline, 8 weeks, 3 months after the 8 weeks
measure: Changes in Executive Function of Alzheimer patients with Frontal Assessment Battery
timeFrame: baseline, 8 weeks, 3 months after the 8 weeks
measure: Changes in Functional Capacity of Alzheimer patients with Disability Assessment for Dementia
timeFrame: baseline, 8 weeks, 3 months after the 8 weeks
measure: Changes in Quality of Life of Alzheimer patients with Quality of Life in Alzheimer's Disease scale
timeFrame: baseline, 8 weeks, 3 months after the 8 weeks
measure: Change in Caregiver Burden of Caregivers of Alzheimer patients measured with Zarit Burden Interview
timeFrame: baseline, 8 weeks, 3 months after the 8 weeks
measure: Change in Occupational Balance of Caregivers of Alzheimer patients measured with Occupational Balance Questionnaire.
timeFrame: baseline, 8 weeks, 3 months after the 8 weeks
measure: Change in Executive Function of Caregivers of Alzheimer patients measured with Frontal Assessment Battery
timeFrame: baseline, 8 weeks, 3 months after the 8 weeks
measure: Change in Quality of Life of Caregivers of Alzheimer patients measured with Study Questionnaire Short Form 36 Health Survey
timeFrame: baseline, 8 weeks, 3 months after the 8 weeks
measure: Change in self-compassion of Caregivers of Alzheimer patients measured with Self-Compassion Scale
timeFrame: baseline, 8 weeks, 3 months after the 8 weeks
measure: Change in well-being of Caregivers of Alzheimer patients measured with Ryff's Well-being Scale
timeFrame: baseline, 8 weeks, 3 months after the 8 weeks
Other outcomes:
Locations:
city: San Juan De Alicante
country: Spain
facility: Alicia Sánchez Pérez
state: Alicante
Study officials:
References: