Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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


Condition Intervention
Depression NOS
Major Depressive Disorder
Anxiety NOS
Behavioral: Kirtan Kriya meditation
Behavioral: Relaxation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

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 ]

Enrollment: 40
Study Start Date: March 2010
Study Completion Date: January 2012
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537679

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

Additional Information:
No publications provided

Responsible Party: Helen Lavretsky, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01537679     History of Changes
Other Study ID Numbers: 10-000270; 09-03-086-01D
Study First Received: February 10, 2012
Last Updated: February 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Caregiver
meditation
relaxation
stress

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

ClinicalTrials.gov processed this record on November 27, 2014