Couples Coping With Alzheimer's Disease

Sponsor
Alzheimer's Association (Other)
Overall Status
Unknown status
CT.gov ID
NCT00438724
Collaborator
(none)
200
1
36
5.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Information, counseling and support
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
A Randomized Control Trial of an Intervention for Couples Coping With Alzheimer's Disease
Study Start Date :
Nov 1, 2004
Anticipated Study Completion Date :
Nov 1, 2007

Outcome Measures

Primary Outcome Measures

  1. Changes in dyadic (couple) adjustment []

  2. depression []

Secondary Outcome Measures

  1. Level of anxiety []

  2. satisfaction with social support []

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine New York New York United States 10016

Sponsors and Collaborators

  • Alzheimer's Association

Investigators

  • Principal Investigator: Mary S. Mittelman, DrPH, NYU School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00438724
Other Study ID Numbers:
  • IA0103
  • ZEN-04-1011
First Posted:
Feb 22, 2007
Last Update Posted:
Sep 20, 2007
Last Verified:
Sep 1, 2007

Study Results

No Results Posted as of Sep 20, 2007