Meditation to Reduce Caregiver Stress
This study has been completed.
Information provided by (Responsible Party):
Helen Lavretsky, University of California, Los Angeles
First received: February 10, 2012
Last updated: February 17, 2012
Last verified: February 2012
The purpose of this study is to determine whether meditation will reduce stress and depressive of adult caregivers of a person with dementia.
Major Depressive Disorder
Behavioral: Kirtan Kriya meditation
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
||Meditation or Relaxation Used to Reduce Stress Response and Improve Cognitive Functioning in Older Family Dementia Caregivers
Primary Outcome Measures:
- Hamilton Depression Rating Scale (HDRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Caregiver Burden Scale [ Time Frame: Week 1 and 8 ] [ Designated as safety issue: No ]
- Connor-Davidson Resilience scale (CD-RISC) [ Time Frame: Week 1 and 8 ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2010 (Final data collection date for primary outcome measure)
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
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
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.
|Ages Eligible for Study:
||45 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537679
|UCLA Semel Institute
|Los Angeles, California, United States, 90095 |
University of California, Los Angeles
||Helen Lavretsky, M.D.
||University of California, Los Angeles
No publications provided
||Helen Lavretsky, Professor, University of California, Los Angeles
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 10, 2012
||February 17, 2012
||United States: Institutional Review Board
Keywords provided by University of California, Los Angeles:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2013
Depressive Disorder, Major