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Meditation for Dementia Caregivers Major Depressive Disorder in Family Dementia Caregivers

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ClinicalTrials.gov Identifier: NCT02122068
Recruitment Status : Completed
First Posted : April 24, 2014
Last Update Posted : May 12, 2017
Friends of Semel Institute
Morris A. Hazan Memorial Foundation
Information provided by (Responsible Party):
Felipe Jain, University of California, Los Angeles

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. Central Meditation and Imagery Therapy (CMIT) is a novel group mindfulness and guided imagery intervention designed to help caregivers reduce depressive symptoms and cope with the stress of caregiving. A small study suggested that CMIT techniques are feasible for dementia caregivers, and resulted in a reduction of depressive and anxiety symptoms. The largest benefits were shown to occur within the first 4 weeks, and were maintained at 3 months post treatment. The early benefits of CMIT were further described in a recent trial of CMIT for patients with recurrent depression, which demonstrated promising improvement in depressive symptoms, with the largest benefits occurring within the first 4 weeks. We have therefore shortened CMIT for caregivers from 8 weeks to 4 weeks, and aim to study the effects of the four-week version (Central Meditation and Imagery Therapy, Short Term, CMIT-ST) on dementia caregivers with elevated depressive symptoms. We will conduct a pilot feasibility of CMIT-ST 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 CMIT-ST. After 4 weeks, the group assigned to the relaxation recording will then have the opportunity to participate in CMIT-ST.

To measure the effects of CMIT-ST, we will obtain depression symptom ratings and questionnaires about psychological symptoms before and after CMIT-ST. We will also study the biological effects of CMIT-ST. 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.

Condition or disease Intervention/treatment Phase
Central Meditation and Imagery Therapy Relaxation Recording Behavioral: Central Meditation and Imagery Therapy Behavioral: Relaxation cd Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Central Meditation and Imagery Therapy for Major Depressive Disorder in Family Dementia Caregivers
Study Start Date : April 2014
Primary Completion Date : September 2015
Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Central Meditation and Imagery Therapy
Meditation and mindfulness 4 week program
Behavioral: Central Meditation and Imagery Therapy
4 week long meditation and mindfulness intervention
Active Comparator: Relaxation cd
Listening to a relaxation cd
Behavioral: Relaxation cd

Primary Outcome Measures :
  1. Hamilton Depression Rating Scale [ Time Frame: End of intervention (4 weeks) ]

Secondary Outcome Measures :
  1. Hamilton Depression Rating Scale [ Time Frame: 1 to 3 months post intervention ]

Other Outcome Measures:
  1. Heart rate variability: high frequency [ Time Frame: End of study (4 weeks) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02122068

United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, San Francisco
Friends of Semel Institute
Morris A. Hazan Memorial Foundation
Principal Investigator: Felipe A Jain, MD University of California, Los Angeles

Additional Information:
Responsible Party: Felipe Jain, Clinical Instructor of Psychiatry, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02122068     History of Changes
Other Study ID Numbers: CMIT003
First Posted: April 24, 2014    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017

Keywords provided by Felipe Jain, University of California, Los Angeles:

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders