Couples Coping With Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

A Randomized Control Trial of an Intervention for Couples Coping With Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00438724
• Other study ID #: IA0103
• Secondary ID: ZEN-04-1011
• Status: Recruiting
• Phase: N/A
• First received: February 21, 2007
• Last updated: September 19, 2007
• Start date: November 2004
• Est. completion date: November 2007

Study information

• Verified date: September 2007
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Aging
• Alzheimer Disease
• Dementia

Intervention

Behavioral:
• Information, counseling and support

Locations

Country	Name	City	State
United States	Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Alzheimer's Association

Country where clinical trial is conducted

United States, 

References & Publications (4)

Epstein, CE; Auclair, U and Mittelman, M. Couples Counseling in Alzheimer's Disease: First Observations of a Novel Intervention Study. Clinical Gerontologist 30(2): 21-35, 2007.

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. — View Citation

Morrissey MV. Rethinking the benefits of an adapted version of 'Alzheimer Café' for individuals with Alzheimer's and their partners. Int J Psychiatr Nurs Res. 2006 Sep;12(1):1393-401. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in dyadic (couple) adjustment
Primary	depression
Secondary	Level of anxiety
Secondary	satisfaction with social support