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Meditation to Reduce Caregiver Stress (Meditation)

Primary Purpose

Depression NOS, Major Depressive Disorder, Anxiety NOS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kirtan Kriya meditation
Relaxation
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression NOS focused on measuring Caregiver, meditation, relaxation, stress

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Caregivers of relatives with dementia who present to the Alzheimer s Disease Center 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, 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). This criteria will ensure that the caregivers had been affected by substantial chronic stress, and they will also meet criteria specified below.
  2. Adequate written and oral fluency in English to understand and complete study forms and converse with study personnel.
  3. Caregivers enrolled in the trial could meet the DSM-IVR criteria for minor depression or depression not otherwise specified (NOS), but not for other diagnosis of unipolar or bipolar major depression.
  4. Score between 6 and 15 on the Hamilton Depression Rating Scale-24 item (HAM-D).
  5. Score of 26 or higher on the Folstein Mini-Mental State Examination (MMSE).

Exclusion Criteria:

  1. Current diagnosis of unipolar major depression, schizophrenia, bipolar, psychotic disorders including psychotic depression or dementia, attention deficit or hyperactivity disorder, anxiety, and alcohol or drug dependence. Those with lifetime history of psychiatric conditions other than unipolar major depression will be also excluded.
  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; recent head trauma with loss of consciousness; recent stroke with residual neurological symptoms; recent cancer with ongoing treatment, or any other medical conditions requiring weekly visits to PCP or pending surgery).
  3. Level of suicidal risk precludes safe treatment on an outpatient basis with Hamilton Depression rating scale item number 3 rated as = 3.
  4. Subjects reporting daily use of alcohol will be excluded.
  5. Diagnosis of amnestic MCI by the analyses of delayed verbal recall on the California Verbal Learning Scale that will be 1.5 SD below the age/education adjusted norms for the general population.

Sites / Locations

  • UCLA Semel Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Meditation Intervention

Relaxation Intervention

Arm Description

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale (HDRS)

Secondary Outcome Measures

Caregiver Burden Scale
Connor-Davidson Resilience scale (CD-RISC)

Full Information

First Posted
February 10, 2012
Last Updated
November 23, 2016
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT01537679
Brief Title
Meditation to Reduce Caregiver Stress
Acronym
Meditation
Official Title
Meditation or Relaxation Used to Reduce Stress Response and Improve Cognitive Functioning in Older Family Dementia Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether meditation will reduce stress and depressive of adult caregivers of a person with dementia.
Detailed Description
This is an 8-week study to determine if meditation or listening to a relaxation CD will be effective in reducing depressive symptoms and stress, and in improving memory and cognition of caregivers who perform a daily meditation for 12 minutes a day for 8 weeks compared to caregivers listening to a relaxation CD for 12 minutes a day for 8 weeks. A second purpose of this study is to examine the role of genetic and inflammatory markers in response to listening to a relaxation CD and meditation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression NOS, Major Depressive Disorder, Anxiety NOS
Keywords
Caregiver, meditation, relaxation, stress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meditation Intervention
Arm Type
Other
Arm Title
Relaxation Intervention
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Kirtan Kriya meditation
Other Intervention Name(s)
Kundalini yoga meditation
Intervention Description
Meditation will be taught to 20 caregivers and supervised by Helen Lavretsky, M.D during their first visit. Meditation Kirtan Kriya will be performed for 12 minutes every day at the same time of the day for 8 weeks. Compliance will be monitored during visits and by daily diaries that will be reviewed at each visit.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation
Other Intervention Name(s)
Relaxation techniques
Intervention Description
Participants in the relaxation group will be asked to relax in a quiet place with eyes closed while listening to the music on the relaxation CD for 12 minutes every day at the same time for 8 weeks.
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HDRS)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Caregiver Burden Scale
Time Frame
Week 1 and 8
Title
Connor-Davidson Resilience scale (CD-RISC)
Time Frame
Week 1 and 8

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 Alzheimer s Disease Center 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, 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). This criteria will ensure that the caregivers had been affected by substantial chronic stress, and they will also meet criteria specified below. Adequate written and oral fluency in English to understand and complete study forms and converse with study personnel. Caregivers enrolled in the trial could meet the DSM-IVR criteria for minor depression or depression not otherwise specified (NOS), but not for other diagnosis of unipolar or bipolar major depression. Score between 6 and 15 on the Hamilton Depression Rating Scale-24 item (HAM-D). Score of 26 or higher on the Folstein Mini-Mental State Examination (MMSE). Exclusion Criteria: Current diagnosis of unipolar major depression, schizophrenia, bipolar, psychotic disorders including psychotic depression or dementia, attention deficit or hyperactivity disorder, anxiety, and alcohol or drug dependence. Those with lifetime history of psychiatric conditions other than unipolar major depression will be also excluded. 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; recent head trauma with loss of consciousness; recent stroke with residual neurological symptoms; recent cancer with ongoing treatment, or any other medical conditions requiring weekly visits to PCP or pending surgery). Level of suicidal risk precludes safe treatment on an outpatient basis with Hamilton Depression rating scale item number 3 rated as = 3. Subjects reporting daily use of alcohol will be excluded. Diagnosis of amnestic MCI by the analyses of delayed verbal recall on the California Verbal Learning Scale that will be 1.5 SD below the age/education adjusted norms for the general population.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Lavretsky, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Semel Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.semel.ucla.edu/latelife
Description
Meditation to Reduce Caregiver Stress

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