Alzheimer DiseaseNCT03858283
Mindfulness for Alzheimer Caregivers
A study testing Mindfulness Based Health Care (MBHC) Program in people with Alzheimer Disease and Neurodegenerative Diseases, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Neurodegenerative Diseases, Dementia
- What is being tested?
- Mindfulness Based Health Care (MBHC) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 2 Feb 2019to 13 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Alzheimer Disease, Neurodegenerative Diseases, Dementia
- Being tested
- Mindfulness Based Health Care (MBHC) Program
- Keywords
- Mindfulness, Anxiety and depression symptoms, Caregivers, Alzheimer, neuropsychiatric disorders
- Medical subject headings
- Alzheimer Disease, Neurodegenerative Diseases, Dementia, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Health Care (MBHC) ProgramBehavioural
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 group | Role | What they receive |
|---|---|---|
| Mindfulness Based Health Care Program | Experimental | Not described Receives: Behavioral: Mindfulness Based Health Care (MBHC) Program |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: baseline, 8 weeks, 3 months after the 8 weeks
Secondary outcomes (10)
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.
Measured: baseline, 8 weeks, 3 months after the 8 weeks
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
Measured: baseline, 8 weeks, 3 months after the 8 weeks
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)
Measured: 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
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.
Measured: baseline, 8 weeks, 3 months after the 8 weeks
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.
Measured: baseline, 8 weeks, 3 months after the 8 weeks
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.
Measured: baseline, 8 weeks, 3 months after the 8 weeks
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
Measured: 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
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
Measured: baseline, 8 weeks, 3 months after the 8 weeks
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.
Measured: 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
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.
Measured: baseline, 8 weeks, 3 months after the 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start2 Feb 2019
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALICIA SANCHEZ PEREZ, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858283
- Sponsor's protocol ID
- Mind01UMH
- Status last verified
- Apr 2022
- First submitted
- 26 Feb 2019
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Based Health Care (MBHC) Program for Caregivers in the Neuropsychiatric Disorders in Alzheimer Patients and Anxiety and Depression in Caregivers
- ClinicalTrials.gov ID
- NCT03858283
- Acronym / sponsor ID
- Mind01UMH
- Conditions
- Alzheimer Disease, Neurodegenerative Diseases, Dementia
- Keywords
- Mindfulness, Anxiety and depression symptoms, Caregivers, Alzheimer, neuropsychiatric disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 28 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Health Care Program | Experimental | Behavioral: Mindfulness Based Health Care (MBHC) Program |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Health Care (MBHC) ProgramMindfulness 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 | Behavioural | Mindfulness Based Health Care Program |
Primary outcome
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)
10 secondary outcomes
Changes in Cognitive Function of Alzheimer patients with Mini Mental State Examination
Time frame: 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
Changes in Functional Capacity of Alzheimer patients with Disability Assessment for Dementia
Time frame: 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
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
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
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
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
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
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
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Health Care (MBHC) Program in people with Alzheimer Disease and Neurodegenerative Diseases, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Neuropsychiatric disorders of Alzheimer patients measured with Neuropsychiatric inventory (time frame: baseline, 8 weeks, 3 months after the 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.