Meditation for Dementia Caregivers Major Depressive Disorder in Family Dementia Caregivers

Mentalizing Imagery Therapy for Major Depressive Disorder in Family Dementia Caregivers

Family dementia caregivers provide a needed service to relatives with dementia and to society, but are often at risk for consequences to their own health such as depression, reduced immune system function, and burnout. Mentalizing Imagery Therapy (MIT, previously known as Central Meditation and Imagery Therapy) is a novel group mindfulness and guided imagery intervention designed to help caregivers reduce depressive symptoms and cope with the stress of caregiving. We will conduct a pilot feasibility of MIT versus home relaxation practice with 24 dementia caregivers. Half of the caregivers will be randomly assigned to receive a relaxation recording, while the other half will receive MIT.

To measure the effects of MIT, we will obtain depression symptom ratings and questionnaires about psychological symptoms before and after MIT. We will also study the biological effects of MIT. We will do so by measuring brain activity, recording the pulse in order to determine variation in beat to beat intervals of the heart, and studying patterns of gene expression.

Study Overview

• Status: Completed
• Conditions: Mentalizing Imagery Therapy; Relaxation Recording
• Intervention / Treatment: Behavioral: Mentalizing Imagery Therapy; Behavioral: Relaxation cd

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Caregivers of relatives with dementia who present to the UCLA Alzheimer and Dementia Care Program, or other UCLA geriatric or memory clinics for evaluation of dementia, cognitive impairment and/or co-existing behavioral disturbances.
2. Caregivers will be identified by the family member with dementia or the physician as the primary source of assistance and/or support
3. 45 years of age or older
4. Patient Health Questionnaire Score > 9
5. 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).
6. Adequate written and oral fluency in English to understand and complete study forms and converse with study personnel.

Exclusion Criteria:

• Current diagnosis of schizophrenia or any psychotic disorder including psychotic depression, mania, alcohol or drug dependence, mental retardation, any pervasive developmental disorder or cognitive disorder (according to DSM-IV) criteria.

  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; or pending surgery).

  3. Past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke/ aneurysm; Parkinson's or Huntington's disease; or Multiple Sclerosis.

  4. Participants regularly practicing (≥ 2 times per week) any of the techniques utilized in the study to reduce stress: meditation, guided imagery, yoga.

  5. Active suicidal plan, or suicide attempt within the past month. 6. Excessive use of alcohol, i.e., men whose alcohol consumption exceeds 14 standard drinks per week or 4 drinks per day, and women whose alcohol consumption exceeds 7 standard drinks per week or 3 drinks per day.

  7. Needing to adjust or change anti-depressant treatment, including medications, psychotherapy, repetitive Transcranial Magnetic Stimulation (rTMS), Electroconvulsive Therapy (ECT), or Vagus Nerve Stimulation (VNS).

  8. Ideas of harm toward the care recipient, current violence, or an APS report on file.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mentalizing Imagery Therapy; Meditation and mindfulness 4 week program	Behavioral: Mentalizing Imagery Therapy; 4 week long meditation and mindfulness intervention
Active Comparator: Relaxation cd; Listening to a relaxation cd	Behavioral: Relaxation cd

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Depression Rating Scale	17 item rating scale, range of scores 0-52, higher scores indicate worse outcome	1 week post intervention (5 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick Inventory of Depression Symptoms - Self Report	16 item rating scale, range of scores 0-27, higher scores indicate worse outcome	1 week post intervention (5 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
State Trait Anxiety Inventory	20 item rating scale, scores range from 20 to 80, higher scores indicate worse outcome	1 week post intervention (5 weeks)

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Friends of Semel Institute; Morris A. Hazan Memorial Foundation
• Investigators: Principal Investigator: Felipe A Jain, MD, University of California, Los Angeles

Publications and helpful links

General Publications

• Jain FA, Nazarian N, Lavretsky H. Feasibility of central meditation and imagery therapy for dementia caregivers. Int J Geriatr Psychiatry. 2014 Aug;29(8):870-6. doi: 10.1002/gps.4076. Epub 2014 Jan 29.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: April 16, 2014
• First Submitted That Met QC Criteria: April 22, 2014
• First Posted (Estimate): April 24, 2014

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Depression; Mindfulness; Dementia; Caregiver; Meditation
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Neurocognitive Disorders; Depressive Disorder; Dementia; Depressive Disorder, Major
• Other Study ID Numbers: CMIT003