Meditation to Reduce Caregiver Stress

NCT01537679 | Completed DMC

• 1 other identifier: 10-000270; 09-03-086-01D
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression NOS; Major Depressive Disorder; Anxiety NOS

Keywords

Caregiver; meditation; relaxation; stress

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HDRS)

  8 weeks

Secondary Outcomes (2)

• Caregiver Burden Scale

  Week 1 and 8

• Connor-Davidson Resilience scale (CD-RISC)

  Week 1 and 8

Study Arms (2)

Meditation Intervention

OTHER

Behavioral: Kirtan Kriya meditation

Relaxation Intervention

OTHER

Behavioral: Relaxation

Interventions

Kirtan Kriya meditation BEHAVIORAL

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.

Also known as: Kundalini yoga meditation

Meditation Intervention

Relaxation BEHAVIORAL

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.

Also known as: Relaxation techniques

Relaxation Intervention

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Semel Institute

Los Angeles, California, 90095, United States

Location

Related Links

• Meditation to Reduce Caregiver Stress

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Anxiety Disorders

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Helen Lavretsky, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2012
• First Posted: February 23, 2012
• Study Start: March 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: January 1, 2012
• Last Updated: November 28, 2016

Record last verified: 2016-11

Locations

US (1)