Couples Coping With Alzheimer's Disease
Recruitment status was Recruiting
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.
Behavioral: Information, counseling and support
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||A Randomized Control Trial of an Intervention for Couples Coping With Alzheimer's Disease|
- Changes in dyadic (couple) adjustment
- Level of anxiety
- satisfaction with social support
|Study Start Date:||November 2004|
|Estimated Study Completion Date:||November 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438724
|United States, New York|
|Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine||Recruiting|
|New York, New York, United States, 10016|
|Contact: Cynthia Epstein 212-263-1056 firstname.lastname@example.org|
|Contact: Ursula Auclair 212-263-2245 email@example.com|
|Principal Investigator:||Mary S. Mittelman, DrPH||NYU School of Medicine|