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Couples Coping With Alzheimer's Disease

NCT ID: NCT00438724

Last Updated: 2007-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-11-30

Brief Summary

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The purpose of this study is to test the efficacy of a new couples counseling intervention for people recently diagnosed with early Alzheimer's disease and their spouses. The study hypothesis is that counseling the couple shortly after the diagnosis, and while the functional impact of the illness is still relatively mild, will have a significant impact on their ability to provide support for each other.

Detailed Description

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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.

Conditions

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Aging Alzheimer Disease Dementia

Keywords

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Caregivers Caregiving Spousal relationships cognition disorders therapy mental health psychosocial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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Information, counseling and support

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alzheimer's Association

OTHER

Sponsor Role lead

Principal Investigators

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Mary S. Mittelman, DrPH

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

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Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Cynthia Epstein

Role: primary

Ursula Auclair

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 17016901 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16019290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11316839 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19865591 (View on PubMed)

Other Identifiers

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ZEN-04-1011

Identifier Type: -

Identifier Source: secondary_id

IA0103

Identifier Type: -

Identifier Source: org_study_id