Couples Coping With Alzheimer's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Aging, Alzheimer Disease, Dementia

Intervention / Treatment
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* Behavioral: Information, counseling and support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Information, counseling and support|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in dyadic (couple) adjustment |  |  | 
| depression |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of anxiety |  |  | 
| satisfaction with social support |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregivers, Caregiving, Spousal relationships, cognition disorders, therapy, mental health, psychosocial