- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00438724
Couples Coping With Alzheimer's Disease
A Randomized Control Trial of an Intervention for Couples Coping With Alzheimer's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The majority of people with Alzheimer's disease (AD) live at home with their spouses. AD erodes the ability of each member of the couple to support each other. Moreover, couples may be unaccustomed to seeking or accepting emotional and practical support from family members or formal resources. Even though AD can have a major negative impact on each member of the couple and on their relationship, their needs have generally been addressed separately, often without sufficient appreciation for the importance of their ongoing relationship. Previous studies suggest that by improving support for both members of the couple, the intervention will have a positive effect on mental health outcomes such as depression and help keep the person with AD at home rather than in a long-term care facility.
One hundred couples will be randomly assigned either to an immediate treatment group or a wait-list control group which will receive treatment four months after enrollment. Participants will receive a formal baseline assessment, consisting of a structured set of questionnaires to assess dyadic (couple) adjustment, social support, depression and anxiety as well as goals for counseling. There will be two follow-up assessments, 2 and 4 months after baseline using the same instruments. All participants will be able to call a counselor for the duration of the study to obtain resource and referral information or in the event of a crisis. The treatment will consist of 6 sessions of couples counseling within a 2-month period. The focus will be on helping each member of the couple to express feelings, needs and issues that have emerged between them as a result of the diagnosis.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10016
- Recruiting
- Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine
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Contact:
- Cynthia Epstein
- Phone Number: 212-263-1056
- Email: cynthia.epstein@med.nyu.edu
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Contact:
- Ursula Auclair
- Phone Number: 212-263-2245
- Email: ursula.auclair@med.nyu.edu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Couples, in which one partner has been diagnosed with AD and is in the mild stage of the disease
- Ages 21 to 90
Exclusion Criteria:
- Severe psychological or physical illness
- Unwillingness to participate in all aspects of the study
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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depression
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Changes in dyadic (couple) adjustment
|
Secondary Outcome Measures
Outcome Measure |
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Level of anxiety
|
satisfaction with social support
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mary S. Mittelman, DrPH, NYU School of Medicine
Publications and helpful links
General Publications
- Morrissey MV. Rethinking the benefits of an adapted version of 'Alzheimer Cafe' for individuals with Alzheimer's and their partners. Int J Psychiatr Nurs Res. 2006 Sep;12(1):1393-401.
- Robinson L, Clare L, Evans K. Making sense of dementia and adjusting to loss: psychological reactions to a diagnosis of dementia in couples. Aging Ment Health. 2005 Jul;9(4):337-47. doi: 10.1080/13607860500114555.
- Gallagher-Thompson D, Dal Canto PG, Jacob T, Thompson LW. A comparison of marital interaction patterns between couples in which the husband does or does not have Alzheimer's disease. J Gerontol B Psychol Sci Soc Sci. 2001 May;56(3):S140-50. doi: 10.1093/geronb/56.3.s140.
- Auclair U, Epstein C, Mittelman M. Couples Counseling in Alzheimer's Disease: Additional Clinical Findings from a Novel Intervention Study. Clin Gerontol. 2009 Apr 1;32(2):130-146. doi: 10.1080/07317110802676809.
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IA0103
- ZEN-04-1011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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