Couples Coping With Alzheimer's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by National Institute on Aging (NIA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00438724
First received: February 21, 2007
Last updated: September 19, 2007
Last verified: September 2007

February 21, 2007
September 19, 2007
November 2004
Not Provided
  • Changes in dyadic (couple) adjustment
  • depression
Same as current
Complete list of historical versions of study NCT00438724 on ClinicalTrials.gov Archive Site
  • Level of anxiety
  • satisfaction with social support
Same as current
Not Provided
Not Provided
 
Couples Coping With Alzheimer's Disease
A Randomized Control Trial of an Intervention for Couples Coping With Alzheimer's Disease

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Aging
  • Alzheimer Disease
  • Dementia
Behavioral: Information, counseling and support
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
November 2007
Not Provided

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
Both
21 Years to 90 Years
No
Not Provided
United States
 
NCT00438724
IA0103, ZEN-04-1011
Not Provided
Not Provided
Alzheimer's Association
Not Provided
Principal Investigator: Mary S. Mittelman, DrPH NYU School of Medicine
National Institute on Aging (NIA)
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP