Mindfulness for Alzheimer Caregivers

NCT03858283 | Terminated

• 1 other identifier: Mind01UMH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Neurodegenerative Diseases; Dementia

Keywords

Mindfulness; Anxiety and depression symptoms; Caregivers; Alzheimer; neuropsychiatric disorders

Outcome Measures

Primary Outcomes (2)

• Changes in Neuropsychiatric disorders of Alzheimer patients measured with Neuropsychiatric inventory

  Neuropsychiatric inventory includes 12 neuropsychiatric symptom domains: delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, nighttime behavioral disturbances, and appetite/eating disturbances. Neuropsychiatric manifestations within a domain are collectively rated by the caregiver in terms of both frequency (1 to 4) and severity (1 to 3), yielding a composite symptom domain score (frequency×severity). Frequency and severity rating scales have defined anchor points to enhance the reliability of caregiver responses. Caregiver distress is rated for each positive neuropsychiatric symptom domain on a scale anchored by scores of 0 (not distressing at all) and 5 (extremely distressing).

  baseline, 8 weeks, 3 months after the 8 weeks

• Changes in Anxiety and depression symptoms in Caregivers of Alzheimer patients measured with Hospital Anxiety and Depression scale

  The Hospital Anxiety and Depression includes 14 items assessing anxiety (7-item) and depression (7-item), which are rated on a 4-point Likert-type (from 0 to 3). The scores in each subscale are computed by summing the corresponding items, with maximum scores of 21 for each subscale. A score of 0-7 is considered as normal, 8-10 as a borderline case, and 11-21 as a case (anxiety or depression)

  baseline, 8 weeks, 3 months after the 8 weeks

Secondary Outcomes (10)

• Changes in Cognitive Function of Alzheimer patients with Mini Mental State Examination

  baseline, 8 weeks, 3 months after the 8 weeks

• Changes in Executive Function of Alzheimer patients with Frontal Assessment Battery

  baseline, 8 weeks, 3 months after the 8 weeks

• Changes in Functional Capacity of Alzheimer patients with Disability Assessment for Dementia

  baseline, 8 weeks, 3 months after the 8 weeks

• Changes in Quality of Life of Alzheimer patients with Quality of Life in Alzheimer's Disease scale

  baseline, 8 weeks, 3 months after the 8 weeks

• Change in Caregiver Burden of Caregivers of Alzheimer patients measured with Zarit Burden Interview

  baseline, 8 weeks, 3 months after the 8 weeks

Study Arms (2)

Mindfulness Based Health Care Program

EXPERIMENTAL

Behavioral: Mindfulness Based Health Care (MBHC) Program

Control

NO INTERVENTION

Interventions

Mindfulness Based Health Care (MBHC) Program 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

Mindfulness Based Health Care Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead

Study Sites (1)

Alicia Sánchez Pérez

Sant Joan d'Alacant, Alicante, 03550, Spain

Location

MeSH Terms

Conditions

Alzheimer Disease; Neurodegenerative Diseases; Dementia; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. Director of the Master's Degree in Occupational Therapy in Neurology

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: February 28, 2019
• Study Start: February 2, 2019
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

ES (1)