Back to resultsMindfulness for Alzheimer Caregivers
Primary Purpose
Alzheimer Disease, Neurodegenerative Diseases, Dementia
Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mindfulness Based Health Care (MBHC) Program
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Mindfulness, Anxiety and depression symptoms, Caregivers, Alzheimer, neuropsychiatric disorders
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)
Sites / Locations
- Alicia Sánchez Pérez
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindfulness Based Health Care Program
Control
Arm Description
Outcomes
Primary Outcome Measures
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).
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)
Secondary Outcome Measures
Changes in Cognitive Function of Alzheimer patients with Mini Mental State Examination
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.
Changes in Executive Function of Alzheimer patients with Frontal Assessment Battery
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
Changes in Functional Capacity of Alzheimer patients with Disability Assessment for Dementia
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)
Changes in Quality of Life of Alzheimer patients with Quality of Life in Alzheimer's Disease scale
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.
Change in Caregiver Burden of Caregivers of Alzheimer patients measured with Zarit Burden Interview
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.
Change in Occupational Balance of Caregivers of Alzheimer patients measured with Occupational Balance Questionnaire.
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.
Change in Executive Function of Caregivers of Alzheimer patients measured with Frontal Assessment Battery
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
Change in Quality of Life of Caregivers of Alzheimer patients measured with Study Questionnaire Short Form 36 Health Survey
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
Change in self-compassion of Caregivers of Alzheimer patients measured with Self-Compassion Scale
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.
Change in well-being of Caregivers of Alzheimer patients measured with Ryff's Well-being Scale
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.
Full Information
NCT ID
NCT03858283
First Posted
February 26, 2019
Last Updated
April 8, 2022
Sponsor
Universidad Miguel Hernandez de Elche
1. Study Identification
Unique Protocol Identification Number
NCT03858283
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to the COVID pandemic, the lockdown in Spain began on 14 March 2020 and after two years we continue with contagion prevention measures that have not made it possible to implement face-to-face mindfulness courses or to evaluate participants.
Study Start Date
February 2, 2019 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
March 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Miguel Hernandez de Elche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Neurodegenerative Diseases, Dementia
Keywords
Mindfulness, Anxiety and depression symptoms, Caregivers, Alzheimer, neuropsychiatric disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Based Health Care Program
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Health Care (MBHC) Program
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in Neuropsychiatric disorders of Alzheimer patients measured with Neuropsychiatric inventory
Description
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).
Time Frame
baseline, 8 weeks, 3 months after the 8 weeks
Title
Changes in Anxiety and depression symptoms in Caregivers of Alzheimer patients measured with Hospital Anxiety and Depression scale
Description
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)
Time Frame
baseline, 8 weeks, 3 months after the 8 weeks
Secondary Outcome Measure Information:
Title
Changes in Cognitive Function of Alzheimer patients with Mini Mental State Examination
Description
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.
Time Frame
baseline, 8 weeks, 3 months after the 8 weeks
Title
Changes in Executive Function of Alzheimer patients with Frontal Assessment Battery
Description
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
Time Frame
baseline, 8 weeks, 3 months after the 8 weeks
Title
Changes in Functional Capacity of Alzheimer patients with Disability Assessment for Dementia
Description
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)
Time Frame
baseline, 8 weeks, 3 months after the 8 weeks
Title
Changes in Quality of Life of Alzheimer patients with Quality of Life in Alzheimer's Disease scale
Description
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.
Time Frame
baseline, 8 weeks, 3 months after the 8 weeks
Title
Change in Caregiver Burden of Caregivers of Alzheimer patients measured with Zarit Burden Interview
Description
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.
Time Frame
baseline, 8 weeks, 3 months after the 8 weeks
Title
Change in Occupational Balance of Caregivers of Alzheimer patients measured with Occupational Balance Questionnaire.
Description
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.
Time Frame
baseline, 8 weeks, 3 months after the 8 weeks
Title
Change in Executive Function of Caregivers of Alzheimer patients measured with Frontal Assessment Battery
Description
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
Time Frame
baseline, 8 weeks, 3 months after the 8 weeks
Title
Change in Quality of Life of Caregivers of Alzheimer patients measured with Study Questionnaire Short Form 36 Health Survey
Description
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
Time Frame
baseline, 8 weeks, 3 months after the 8 weeks
Title
Change in self-compassion of Caregivers of Alzheimer patients measured with Self-Compassion Scale
Description
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.
Time Frame
baseline, 8 weeks, 3 months after the 8 weeks
Title
Change in well-being of Caregivers of Alzheimer patients measured with Ryff's Well-being Scale
Description
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.
Time Frame
baseline, 8 weeks, 3 months after the 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
Alicia Sánchez Pérez
City
San Juan De Alicante
State/Province
Alicante
ZIP/Postal Code
03550
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Mindfulness for Alzheimer Caregivers
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