Back to resultsMeditation for Dementia Caregivers Major Depressive Disorder in Family Dementia Caregivers
Primary Purpose
Mentalizing Imagery Therapy, Relaxation Recording
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mentalizing Imagery Therapy
Relaxation cd
Sponsored by
About this trial
This is an interventional treatment trial for Mentalizing Imagery Therapy focused on measuring Meditation, Mindfulness, Caregiver, Dementia, Depression
Eligibility Criteria
Inclusion Criteria:
- Caregivers of relatives with dementia who present to the UCLA Alzheimer and Dementia Care Program, or other UCLA geriatric or memory clinics for evaluation of dementia, cognitive impairment and/or co-existing behavioral disturbances.
- Caregivers will be identified by the family member with dementia or the physician as the primary source of assistance and/or support
- 45 years of age or older
- Patient Health Questionnaire Score > 9
- In contact with the individual with dementia at least three times/week for no less than one year, and a relative of the care-recipient (i.e., spouse or adult child).
- Adequate written and oral fluency in English to understand and complete study forms and converse with study personnel.
Exclusion Criteria:
Current diagnosis of schizophrenia or any psychotic disorder including psychotic depression, mania, alcohol or drug dependence, mental retardation, any pervasive developmental disorder or cognitive disorder (according to DSM-IV) criteria.
2. Medically unstable, delirious, or terminally ill (e.g. medical illness requiring hospitalization or intense outpatient management, such as heart disease; heart attack in the past 6 months; congestive heart failure; severe heart arrythmias; unstable hypertension; poorly controlled diabetes; or pending surgery).
3. Past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke/ aneurysm; Parkinson's or Huntington's disease; or Multiple Sclerosis.
4. Participants regularly practicing (≥ 2 times per week) any of the techniques utilized in the study to reduce stress: meditation, guided imagery, yoga.
5. Active suicidal plan, or suicide attempt within the past month. 6. Excessive use of alcohol, i.e., men whose alcohol consumption exceeds 14 standard drinks per week or 4 drinks per day, and women whose alcohol consumption exceeds 7 standard drinks per week or 3 drinks per day.
7. Needing to adjust or change anti-depressant treatment, including medications, psychotherapy, repetitive Transcranial Magnetic Stimulation (rTMS), Electroconvulsive Therapy (ECT), or Vagus Nerve Stimulation (VNS).
8. Ideas of harm toward the care recipient, current violence, or an APS report on file.
Sites / Locations
- University of California, Los Angeles
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mentalizing Imagery Therapy
Relaxation cd
Arm Description
Meditation and mindfulness 4 week program
Listening to a relaxation cd
Outcomes
Primary Outcome Measures
Hamilton Depression Rating Scale
17 item rating scale, range of scores 0-52, higher scores indicate worse outcome
Secondary Outcome Measures
Quick Inventory of Depression Symptoms - Self Report
16 item rating scale, range of scores 0-27, higher scores indicate worse outcome
Full Information
NCT ID
NCT02122068
First Posted
April 16, 2014
Last Updated
January 19, 2021
Sponsor
University of California, San Francisco
Collaborators
Friends of Semel Institute, Morris A. Hazan Memorial Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02122068
Brief Title
Meditation for Dementia Caregivers Major Depressive Disorder in Family Dementia Caregivers
Official Title
Mentalizing Imagery Therapy for Major Depressive Disorder in Family Dementia Caregivers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Friends of Semel Institute, Morris A. Hazan Memorial Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Family dementia caregivers provide a needed service to relatives with dementia and to society, but are often at risk for consequences to their own health such as depression, reduced immune system function, and burnout. Mentalizing Imagery Therapy (MIT, previously known as Central Meditation and Imagery Therapy) is a novel group mindfulness and guided imagery intervention designed to help caregivers reduce depressive symptoms and cope with the stress of caregiving. We will conduct a pilot feasibility of MIT versus home relaxation practice with 24 dementia caregivers. Half of the caregivers will be randomly assigned to receive a relaxation recording, while the other half will receive MIT.
To measure the effects of MIT, we will obtain depression symptom ratings and questionnaires about psychological symptoms before and after MIT. We will also study the biological effects of MIT. We will do so by measuring brain activity, recording the pulse in order to determine variation in beat to beat intervals of the heart, and studying patterns of gene expression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mentalizing Imagery Therapy, Relaxation Recording
Keywords
Meditation, Mindfulness, Caregiver, Dementia, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mentalizing Imagery Therapy
Arm Type
Experimental
Arm Description
Meditation and mindfulness 4 week program
Arm Title
Relaxation cd
Arm Type
Active Comparator
Arm Description
Listening to a relaxation cd
Intervention Type
Behavioral
Intervention Name(s)
Mentalizing Imagery Therapy
Intervention Description
4 week long meditation and mindfulness intervention
Intervention Type
Behavioral
Intervention Name(s)
Relaxation cd
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale
Description
17 item rating scale, range of scores 0-52, higher scores indicate worse outcome
Time Frame
1 week post intervention (5 weeks)
Secondary Outcome Measure Information:
Title
Quick Inventory of Depression Symptoms - Self Report
Description
16 item rating scale, range of scores 0-27, higher scores indicate worse outcome
Time Frame
1 week post intervention (5 weeks)
Other Pre-specified Outcome Measures:
Title
State Trait Anxiety Inventory
Description
20 item rating scale, scores range from 20 to 80, higher scores indicate worse outcome
Time Frame
1 week post intervention (5 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Caregivers of relatives with dementia who present to the UCLA Alzheimer and Dementia Care Program, or other UCLA geriatric or memory clinics for evaluation of dementia, cognitive impairment and/or co-existing behavioral disturbances.
Caregivers will be identified by the family member with dementia or the physician as the primary source of assistance and/or support
45 years of age or older
Patient Health Questionnaire Score > 9
In contact with the individual with dementia at least three times/week for no less than one year, and a relative of the care-recipient (i.e., spouse or adult child).
Adequate written and oral fluency in English to understand and complete study forms and converse with study personnel.
Exclusion Criteria:
Current diagnosis of schizophrenia or any psychotic disorder including psychotic depression, mania, alcohol or drug dependence, mental retardation, any pervasive developmental disorder or cognitive disorder (according to DSM-IV) criteria.
2. Medically unstable, delirious, or terminally ill (e.g. medical illness requiring hospitalization or intense outpatient management, such as heart disease; heart attack in the past 6 months; congestive heart failure; severe heart arrythmias; unstable hypertension; poorly controlled diabetes; or pending surgery).
3. Past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke/ aneurysm; Parkinson's or Huntington's disease; or Multiple Sclerosis.
4. Participants regularly practicing (≥ 2 times per week) any of the techniques utilized in the study to reduce stress: meditation, guided imagery, yoga.
5. Active suicidal plan, or suicide attempt within the past month. 6. Excessive use of alcohol, i.e., men whose alcohol consumption exceeds 14 standard drinks per week or 4 drinks per day, and women whose alcohol consumption exceeds 7 standard drinks per week or 3 drinks per day.
7. Needing to adjust or change anti-depressant treatment, including medications, psychotherapy, repetitive Transcranial Magnetic Stimulation (rTMS), Electroconvulsive Therapy (ECT), or Vagus Nerve Stimulation (VNS).
8. Ideas of harm toward the care recipient, current violence, or an APS report on file.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe A Jain, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24477920
Citation
Jain FA, Nazarian N, Lavretsky H. Feasibility of central meditation and imagery therapy for dementia caregivers. Int J Geriatr Psychiatry. 2014 Aug;29(8):870-6. doi: 10.1002/gps.4076. Epub 2014 Jan 29.
Results Reference
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Meditation for Dementia Caregivers Major Depressive Disorder in Family Dementia Caregivers
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