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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

Tracking Information
First Submitted Date  ICMJE February 26, 2019
First Posted Date  ICMJE February 28, 2019
Last Update Posted Date March 1, 2019
Actual Study Start Date  ICMJE February 2, 2019
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
  • 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).
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2019)
  • 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.
  • 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
  • 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)
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
  • 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.
  • 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
  • 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)
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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)
  • Change in self-efficacy and well-being of Caregivers of Alzheimer patients measured with General Self-Efficacy Scale and Ryff's Well-being Scale [ Time Frame: baseline, 8 weeks, 3 months after the 8 weeks ]
    General Self-Efficacy Scale and 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness for Alzheimer Caregivers
Official Title  ICMJE Mindfulness Based Health Care (MBHC) Program for Caregivers in the Neuropsychiatric Disorders in Alzheimer Patients and Anxiety and Depression in Caregivers
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Alzheimer Disease
  • Neurodegenerative Diseases
  • Dementia
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Mindfulness Based Health Care Program
    Intervention: Behavioral: Mindfulness Based Health Care (MBHC) Program
  • No Intervention: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 27, 2019)
145
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2021
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Alicia Sánchez Pérez, Occupational therapist and Ph +34 96.591.9579 alicia.sanchez@umh.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03858283
Other Study ID Numbers  ICMJE Mind01UMH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party ALICIA SANCHEZ PEREZ, Universidad Miguel Hernandez de Elche
Study Sponsor  ICMJE Universidad Miguel Hernandez de Elche
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidad Miguel Hernandez de Elche
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP