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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 : November 16, 2018
Sponsor:
Collaborators:
Friends of Semel Institute
Morris A. Hazan Memorial Foundation
Information provided by (Responsible Party):
Felipe Jain, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE April 16, 2014
First Posted Date  ICMJE April 24, 2014
Last Update Posted Date November 16, 2018
Study Start Date  ICMJE April 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2014)
Hamilton Depression Rating Scale [ Time Frame: End of intervention (4 weeks) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02122068 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2014)
Hamilton Depression Rating Scale [ Time Frame: 1 to 3 months post intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 22, 2014)
Heart rate variability: high frequency [ Time Frame: End of study (4 weeks) ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Meditation for Dementia Caregivers Major Depressive Disorder in Family Dementia Caregivers
Official Title  ICMJE Central Meditation and Imagery Therapy for Major Depressive Disorder in Family Dementia Caregivers
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Central Meditation and Imagery Therapy
  • Relaxation Recording
Intervention  ICMJE
  • Behavioral: Central Meditation and Imagery Therapy
    4 week long meditation and mindfulness intervention
  • Behavioral: Relaxation cd
Study Arms  ICMJE
  • Experimental: Central Meditation and Imagery Therapy
    Meditation and mindfulness 4 week program
    Intervention: Behavioral: Central Meditation and Imagery Therapy
  • Active Comparator: Relaxation cd
    Listening to a relaxation cd
    Intervention: Behavioral: Relaxation cd
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2016)
26
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2014)
24
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02122068
Other Study ID Numbers  ICMJE CMIT003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Felipe Jain, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE
  • Friends of Semel Institute
  • Morris A. Hazan Memorial Foundation
Investigators  ICMJE
Principal Investigator: Felipe A Jain, MD University of California, Los Angeles
PRS Account University of California, San Francisco
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP