## Protocol Section
### Identification Module
**NCT ID:** NCT01537679

**Acronym:** Meditation

**Brief Title:** Meditation to Reduce Caregiver Stress

**Official Title:** Meditation or Relaxation Used to Reduce Stress Response and Improve Cognitive Functioning in Older Family Dementia Caregivers

#### Organization Study ID Info
**ID:** 10-000270; 09-03-086-01D
#### Organization
**Class:** OTHER
**Full Name:** University of California, Los Angeles
### Status Module
#### Completion Date
**Date:** 2012-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-11-28

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-11-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-08

**Type:** ACTUAL

#### Start Date
**Date:** 2010-03

**Status Verified Date:** 2016-11

#### Study First Post Date
**Date:** 2012-02-23
**Type:** ESTIMATED
**Study First Submit Date:** 2012-02-10
**Study First Submit QC Date:** 2012-02-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of California, Los Angeles

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Depression NOS

- Major Depressive Disorder

- Anxiety NOS

**Keywords:**

- Caregiver

- meditation

- relaxation

- stress

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: Kirtan Kriya meditation

**Label:** Meditation Intervention

**Type:** OTHER

#### Arm Group 2

**Intervention Names:**

- Behavioral: Relaxation

**Label:** Relaxation Intervention

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Meditation Intervention

**Description:** 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.

**Name:** Kirtan Kriya meditation

**Other Names:**

- Kundalini yoga meditation

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Relaxation Intervention

**Description:** 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.

**Name:** Relaxation

**Other Names:**

- Relaxation techniques

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Hamilton Depression Rating Scale (HDRS)

**Time Frame:** 8 weeks

#### Secondary Outcomes

**Measure:** Caregiver Burden Scale

**Time Frame:** Week 1 and 8

**Measure:** Connor-Davidson Resilience scale (CD-RISC)

**Time Frame:** Week 1 and 8

### Eligibility Module

**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.

**Minimum Age:** 45 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Los Angeles

**Country:** United States

**Facility:** UCLA Semel Institute

**State:** California

**Zip:** 90095

#### Overall Officials

**Official 1:**

**Affiliation:** University of California, Los Angeles

**Name:** Helen Lavretsky, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### See Also Links

**Label:** Meditation to Reduce Caregiver Stress

**URL:** http://www.semel.ucla.edu/latelife

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6904

- Name: Dementia

- Relevance: LOW

- As Found: Unknown

- ID: M7058

- Name: Depression

- Relevance: LOW

- As Found: Unknown

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Depressive Disorder

- ID: M7060

- Name: Depressive Disorder, Major

- Relevance: HIGH

- As Found: Major Depressive Disorder

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003866

- Term: Depressive Disorder

- ID: D000003865

- Term: Depressive Disorder, Major

### Misc Info Module

- Version Holder: 2024-05-24
