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Mindfulness for Alzheimer Caregivers

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ClinicalTrials.gov Identifier: NCT03858283
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
ALICIA SANCHEZ PEREZ, Universidad Miguel Hernandez de Elche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Neurodegenerative Diseases Dementia Behavioral: Mindfulness Based Health Care (MBHC) Program Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness Based Health Care (MBHC) Program for Caregivers in the Neuropsychiatric Disorders in Alzheimer Patients and Anxiety and Depression in Caregivers
Actual Study Start Date : February 2, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Mindfulness Based Health Care Program Behavioral: 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
No Intervention: Control


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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)

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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 is scale of 26 items measures self-compassion as a system-level balance between compassionate self-responding (kindness,common humanity, and mindfulness) and reduced uncompassionate self-responding (reducedself-judgment, isolation, andover-identification)

  10. 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 consisting of 39 items to be rated on a scale of 1 to 6, 1 indicating strong disagreement and 6 indicating strong agreement. In its original version, this scale includes six dimensions: self-acceptance, purpose in life, positive relations with others, autonomy, environmental mastery, and personal growth.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858283


Contacts
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Contact: Alicia Sánchez Pérez, Occupational therapist and Ph +34 96.591.9579 alicia.sanchez@umh.es

Locations
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Spain
Alicia Sánchez Pérez Recruiting
San Juan De Alicante, Alicante, Spain, 03550
Contact: Alicia Sánchez Pérez, Occupational therapist, PhD    +34 96.591.9579      
Contact       alicia.sanchez@umh.es   
Sponsors and Collaborators
Universidad Miguel Hernandez de Elche
More Information
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Responsible Party: ALICIA SANCHEZ PEREZ, Principal Investigator, Universidad Miguel Hernandez de Elche
ClinicalTrials.gov Identifier: NCT03858283    
Other Study ID Numbers: Mind01UMH
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ALICIA SANCHEZ PEREZ, Universidad Miguel Hernandez de Elche:
Mindfulness
Anxiety and depression symptoms
Caregivers
Alzheimer
neuropsychiatric disorders
Additional relevant MeSH terms:
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Alzheimer Disease
Neurodegenerative Diseases
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurocognitive Disorders
Mental Disorders