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
  Purpose

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 Intervention
Aging
Alzheimer Disease
Dementia
Behavioral: Information, counseling and support

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Changes in dyadic (couple) adjustment
  • depression

Secondary Outcome Measures:
  • Level of anxiety
  • satisfaction with social support

Estimated Enrollment: 200
Study Start Date: November 2004
Estimated Study Completion Date: November 2007
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.

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438724

Locations
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    cynthia.epstein@med.nyu.edu   
Contact: Ursula Auclair    212-263-2245    ursula.auclair@med.nyu.edu   
Sponsors and Collaborators
Alzheimer's Association
Investigators
Principal Investigator: Mary S. Mittelman, DrPH NYU School of Medicine
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00438724     History of Changes
Other Study ID Numbers: IA0103, ZEN-04-1011
Study First Received: February 21, 2007
Last Updated: September 19, 2007
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Caregivers
Caregiving
Spousal relationships
cognition disorders
therapy
mental health
psychosocial

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014