Meditation for Dementia Caregivers Major Depressive Disorder in Family Dementia Caregivers

NCT02122068 | Completed

• 1 other identifier: CMIT003
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mentalizing Imagery Therapy; Relaxation Recording

Keywords

Meditation; Mindfulness; Caregiver; Dementia; Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quick Inventory of Depression Symptoms - Self Report

  1 week post intervention (5 weeks)

Other Outcomes (1)

• State Trait Anxiety Inventory

  1 week post intervention (5 weeks)

Study Arms (2)

Mentalizing Imagery Therapy

EXPERIMENTAL

Meditation and mindfulness 4 week program

Behavioral: Mentalizing Imagery Therapy

Relaxation cd

ACTIVE COMPARATOR

Listening to a relaxation cd

Behavioral: Relaxation cd

Interventions

Mentalizing Imagery Therapy BEHAVIORAL

4 week long meditation and mindfulness intervention

Mentalizing Imagery Therapy

Relaxation cd BEHAVIORAL

Relaxation cd

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 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.
• Caregivers will be identified by the family member with dementia or the physician as the primary source of assistance and/or support
• years of age or older
• Patient Health Questionnaire Score \> 9
• 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).
• Adequate written and oral fluency in English to understand and complete study forms and converse with study personnel.

You may not qualify if:

• 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.
• \. 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).
• \. 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.
• \. Participants regularly practicing (≥ 2 times per week) any of the techniques utilized in the study to reduce stress: meditation, guided imagery, yoga.
• \. 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.
• \. Needing to adjust or change anti-depressant treatment, including medications, psychotherapy, repetitive Transcranial Magnetic Stimulation (rTMS), Electroconvulsive Therapy (ECT), or Vagus Nerve Stimulation (VNS).
• \. Ideas of harm toward the care recipient, current violence, or an APS report on file.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Friends of Semel Institute: collaborator
• Morris A. Hazan Memorial Foundation: collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• 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.

  PMID: 24477920 BACKGROUND

MeSH Terms

Conditions

Dementia; Depression

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Felipe A Jain, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 24, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

US (1)