Clinical trial NCT01537679: Meditation to Reduce Caregiver Stress
Official title: Meditation or Relaxation Used to Reduce Stress Response and Improve Cognitive Functioning in Older Family Dementia Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression NOS
Major Depressive Disorder
Anxiety NOS
Keywords: Caregiver
meditation
relaxation
stress
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: 8 weeks
Secondary outcomes:
measure: Caregiver Burden Scale
timeFrame: Week 1 and 8
measure: Connor-Davidson Resilience scale (CD-RISC)
timeFrame: Week 1 and 8
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Semel Institute
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Helen Lavretsky, M.D.
role: PRINCIPAL_INVESTIGATOR
References: