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OpenTrials
Completed

NCT Number: NCT02122068

Meditation for Dementia Caregivers 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.

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Key information

Conditions

Mentalizing Imagery Therapy Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Depression Mental Disorders Nervous System Diseases Neurocognitive Disorders Relaxation Recording

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 45 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.

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.
  • 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.

Treatment and study plan

Mentalizing Imagery Therapy

Behavioral

4 week long meditation and mindfulness intervention

Relaxation cd

Behavioral

Primary outcomes

  1. Hamilton Depression Rating Scale

    Time frame: 1 week post intervention (5 weeks)

    17 item rating scale, range of scores 0-52, higher scores indicate worse outcome

Secondary outcomes

  1. Quick Inventory of Depression Symptoms - Self Report

    Time frame: 1 week post intervention (5 weeks)

    16 item rating scale, range of scores 0-27, higher scores indicate worse outcome

Other outcomes

  1. State Trait Anxiety Inventory

    Time frame: 1 week post intervention (5 weeks)

    20 item rating scale, scores range from 20 to 80, higher scores indicate worse outcome

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Friends of Semel Institute
  • Morris A. Hazan Memorial Foundation

Registry information

Official study title

Mentalizing Imagery Therapy for Major Depressive Disorder in Family Dementia Caregivers

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 24, 2014
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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