- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03858283
Mindfulness for Alzheimer Caregivers
April 8, 2022 updated by: ALICIA SANCHEZ PEREZ, Universidad Miguel Hernandez de Elche
Mindfulness Based Health Care (MBHC) Program for Caregivers in the Neuropsychiatric Disorders in Alzheimer Patients and Anxiety and Depression in Caregivers
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alicante
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San Juan De Alicante, Alicante, Spain, 03550
- Alicia Sánchez Pérez
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Experimental: Mindfulness Based Health Care 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Neuropsychiatric disorders of Alzheimer patients measured with Neuropsychiatric inventory
Time Frame: baseline, 8 weeks, 3 months after the 8 weeks
|
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
Time Frame: baseline, 8 weeks, 3 months after the 8 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Cognitive Function of Alzheimer patients with Mini Mental State Examination
Time Frame: baseline, 8 weeks, 3 months after the 8 weeks
|
The Mini Mental State Examination is composed of 13 items to assess with scores (0,1,2,3,4,5) according answer.
the main objective is to briefly assess the mental state and allow observe the degree of progression of cognitive status through the following areas: orientation, fixation, concentration and calculation, memory, language and construction.
|
baseline, 8 weeks, 3 months after the 8 weeks
|
Changes in Executive Function of Alzheimer patients with Frontal Assessment Battery
Time Frame: baseline, 8 weeks, 3 months after the 8 weeks
|
The FAB consists of 6 subtests that explore each of the processes controlled by the frontal lobes: 1) similarities (abstract reasoning/conceptualization); 2) lexical fluency (mental flexibility [i.e.
self-organization, strategy and change]); 3) motor series (programming and motor planning); 4) conflicting instructions (sensitivity to interference); 5) Go-no-go test (inhibitory control and impulsiveness); and 6) prehension behavior (ability to inhibit a response to sensorial stimulation [i.e.
environmental autonomy]).
Higher scores of the test imply a better performance, and the total maximum score that can be obtained in the FAB is 18.
The scoring is calculated by adding up the points for each test, which ranges from 0 to 3
|
baseline, 8 weeks, 3 months after the 8 weeks
|
Changes in Functional Capacity of Alzheimer patients with Disability Assessment for Dementia
Time Frame: baseline, 8 weeks, 3 months after the 8 weeks
|
The Disability Assessment for Dementia is composed by 40 items that assess 4 basic ADLs (BADL: hygiene, dressing, continence, and eating; 17 items), and 6 instrumental activities (preparing of meals, use of telephone, finance and correspondence, medication, and leisure and domestic activities; 23 items).
The items also reflect cognitive dimensions of functional capacity in terms of executive functioning: Initiative (13 items), planning and organization (10 items), and execution (17 items)
|
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
Time Frame: baseline, 8 weeks, 3 months after the 8 weeks
|
The Quality of Life in Alzheimer's Disease scale uses 13 items a scale of 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the patient's physical health, mood, relationships, activities, and ability to complete tasks.
Total score range 13-52; higher scores indicate better Quality of life.
|
baseline, 8 weeks, 3 months after the 8 weeks
|
Change in Caregiver Burden of Caregivers of Alzheimer patients measured with Zarit Burden Interview
Time Frame: baseline, 8 weeks, 3 months after the 8 weeks
|
Zarit Burden Interview consists of 22 items scored in 5-point Likert scale from 0 (never) to 4 (nearly always), except for the final item on global burden, rated from 0 (not at all) to 4 (extremely).
The total score ranges from 0 to 88 with higher scores indicating higher burden.
|
baseline, 8 weeks, 3 months after the 8 weeks
|
Change in Occupational Balance of Caregivers of Alzheimer patients measured with Occupational Balance Questionnaire.
Time Frame: baseline, 8 weeks, 3 months after the 8 weeks
|
Occupational Balance Questionnaire consists of 13 items scored in 6-point Likert scale from 0 (completely disagree) to 5 (completely agree).
The total score ranges from 0 to 65 with higher scores higher occupational balance.
|
baseline, 8 weeks, 3 months after the 8 weeks
|
Change in Executive Function of Caregivers of Alzheimer patients measured with Frontal Assessment Battery
Time Frame: baseline, 8 weeks, 3 months after the 8 weeks
|
The FAB consists of 6 subtests that explore each of the processes controlled by the frontal lobes: 1) similarities (abstract reasoning/conceptualization); 2) lexical fluency (mental flexibility [i.e.
self-organization, strategy and change]); 3) motor series (programming and motor planning); 4) conflicting instructions (sensitivity to interference); 5) Go-no-go test (inhibitory control and impulsiveness); and 6) prehension behavior (ability to inhibit a response to sensorial stimulation [i.e.
environmental autonomy]).
Higher scores of the test imply a better performance, and the total maximum score that can be obtained in the FAB is 18.
The scoring is calculated by adding up the points for each test, which ranges from 0 to 3
|
baseline, 8 weeks, 3 months after the 8 weeks
|
Change in Quality of Life of Caregivers of Alzheimer patients measured with Study Questionnaire Short Form 36 Health Survey
Time Frame: baseline, 8 weeks, 3 months after the 8 weeks
|
The Study Questionnaire Short Form 36 Health Survey has eight scaled scores; the scoresare weighted sums of the questions in eachsection.
Scores range from 0 -100 where lower scores =more disability and higher scores= less disability.
This questionnaire include the follow subdimension: Vitality; Physical functioning; Bodily pain; General health perceptions; Physical role functioning; Emotional role functioning; Social role functioning; Mental health
|
baseline, 8 weeks, 3 months after the 8 weeks
|
Change in self-compassion of Caregivers of Alzheimer patients measured with Self-Compassion Scale
Time Frame: baseline, 8 weeks, 3 months after the 8 weeks
|
Self-Compassion Scale measures the three components of self-compassion: shared humanity (SCSCH), mindfulness (SCS-M) and self-kindness (SCS-SK).
It consists of 26 items evaluated with a Likert-type scale from 1 to 5 (1=almost never; 5=almost always).
The total score is obtained with the sum of all items and ranges from 26 to 130 points.
|
baseline, 8 weeks, 3 months after the 8 weeks
|
Change in well-being of Caregivers of Alzheimer patients measured with Ryff's Well-being Scale
Time Frame: baseline, 8 weeks, 3 months after the 8 weeks
|
Ryff's Well-being Scale measures psychological well-being.
It is composed of 39 items that assess 6 dimensions: self-acceptance, autonomy, positive relationships with other people, personal growth, mastery of the environment, and purpose in life.
The response format is a Likert-type scale from 1 (strongly disagree) to 6 (strongly agree).
The range of the total score is 39 to 234 points.
|
baseline, 8 weeks, 3 months after the 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 2, 2019
Primary Completion (Actual)
March 13, 2020
Study Completion (Actual)
March 13, 2020
Study Registration Dates
First Submitted
February 26, 2019
First Submitted That Met QC Criteria
February 27, 2019
First Posted (Actual)
February 28, 2019
Study Record Updates
Last Update Posted (Actual)
April 15, 2022
Last Update Submitted That Met QC Criteria
April 8, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mind01UMH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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