Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00438724
Status:
UNKNOWN
Last Update Posted:
2007-09-20
First Post:
2007-02-21
Brief Title:
Couples Coping With Alzheimers Disease
Sponsor:
Alzheimers Association
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
A Randomized Control Trial of an Intervention for Couples Coping With Alzheimers Disease
Status:
UNKNOWN
Status Verified Date:
2007-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test the efficacy of a new couples counseling intervention for people recently diagnosed with early Alzheimers 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:
The majority of people with Alzheimers 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ZEN-04-1011 | None | None | None |