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Group Therapy for Depressed Dementia Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03092050
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : March 6, 2019
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Felipe A Jain, Massachusetts General Hospital

Brief Summary:
Depression in family caregivers of relatives with Alzheimer's Disorder and related dementias is a serious public health problem. This is a randomized, controlled, single-blind pilot clinical trial of 50 depressed caregivers, to determine the efficacy and mechanisms of group therapy for depressed dementia caregivers.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Guided Imagery and Mindfulness Behavioral: Facilitated Discussion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Group Therapy for Depressed Caregivers of Alzheimer's Disorder and Related Dementias
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Active Comparator: Facilitated Discussion
Weekly facilitated discussion for 4 weeks
Behavioral: Facilitated Discussion
This is a behavioral intervention that involves discussion and group support.

Experimental: Guided Imagery and mindfulness
Weekly guided imagery and mindfulness for 4 weeks
Behavioral: Guided Imagery and Mindfulness
This is a behavioral intervention using guided imagery and mindfulness techniques.

Primary Outcome Measures :
  1. Depression symptoms [ Time Frame: 4 weeks ]
    Self reported depression symptoms (Quick Inventory of Depression Symptoms)

Secondary Outcome Measures :
  1. Depression symptoms - moderate term [ Time Frame: 3 months ]
    Self reported depression symptoms

  2. Depression symptoms - clinician rated [ Time Frame: 4 weeks ]
    Hamilton Depression Rating Scale

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

Endorse clinically relevant baseline depressive symptoms Primary caregiver for a relative with dementia

Exclusion Criteria:

Age < 45 Meditation / guided imagery practice more than twice per week Ideas of harming relative with dementia Current violence towards relative with dementia Adult Protective Services report on file Primary psychiatric disorder other than unipolar major depression Cognitive impairment on the part of the caregiver (Mini Mental State Examination score less than 24) Unstable medical illness Planned surgery Active drug or alcohol abuse Inability to understand written and oral English.

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 identifier (NCT number): NCT03092050

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Contact: Felipe Jain, MD 617-723-4682 Felipe.Jain@MGH.HARVARD.EDU

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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Felipe Jain, MD    617-723-4682    Felipe.Jain@MGH.HARVARD.EDU   
Sponsors and Collaborators
Massachusetts General Hospital
National Institute on Aging (NIA)
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Principal Investigator: Felipe Jain, MD Massachusetts General Hospital

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Responsible Party: Felipe A Jain, Psychiatrist, Massachusetts General Hospital Identifier: NCT03092050     History of Changes
Other Study ID Numbers: MIT001
R21AG051970 ( U.S. NIH Grant/Contract )
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders