Meditation to Reduce Caregiver Stress

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helen Lavretsky, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01537679
First received: February 10, 2012
Last updated: February 17, 2012
Last verified: February 2012

February 10, 2012
February 17, 2012
March 2010
August 2010   (final data collection date for primary outcome measure)
Hamilton Depression Rating Scale (HDRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01537679 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Meditation to Reduce Caregiver Stress
Meditation or Relaxation Used to Reduce Stress Response and Improve Cognitive Functioning in Older Family Dementia Caregivers

The purpose of this study is to determine whether meditation will reduce stress and depressive of adult caregivers of a person with dementia.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Depression NOS
  • Major Depressive Disorder
  • Anxiety NOS
  • 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
  • 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
  • Meditation Intervention
    Intervention: Behavioral: Kirtan Kriya meditation
  • Relaxation Intervention
    Intervention: Behavioral: Relaxation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2012
August 2010   (final data collection date for primary outcome measure)

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.
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01537679
10-000270; 09-03-086-01D
Yes
Helen Lavretsky, University of California, Los Angeles
University of California, Los Angeles
Not Provided
Principal Investigator: Helen Lavretsky, M.D. University of California, Los Angeles
University of California, Los Angeles
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP