Meditation to Reduce Caregiver Stress (Meditation)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01537679
Recruitment Status : Completed
First Posted : February 23, 2012
Last Update Posted : November 28, 2016
Information provided by (Responsible Party):
University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Depression NOS Major Depressive Disorder Anxiety NOS Behavioral: Kirtan Kriya meditation Behavioral: Relaxation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Meditation or Relaxation Used to Reduce Stress Response and Improve Cognitive Functioning in Older Family Dementia Caregivers
Study Start Date : March 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers
U.S. FDA Resources

Arm Intervention/treatment
Meditation Intervention Behavioral: Kirtan Kriya meditation
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.
Other Name: Kundalini yoga meditation
Relaxation Intervention Behavioral: Relaxation
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.
Other Name: Relaxation techniques

Primary Outcome Measures :
  1. Hamilton Depression Rating Scale (HDRS) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Caregiver Burden Scale [ Time Frame: Week 1 and 8 ]
  2. Connor-Davidson Resilience scale (CD-RISC) [ Time Frame: Week 1 and 8 ]

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01537679

United States, California
UCLA Semel Institute
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Principal Investigator: Helen Lavretsky, M.D. University of California, Los Angeles

Additional Information:
Responsible Party: University of California, Los Angeles Identifier: NCT01537679     History of Changes
Other Study ID Numbers: 10-000270; 09-03-086-01D
First Posted: February 23, 2012    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016

Keywords provided by University of California, Los Angeles:

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms