NCT00438724

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

September 20, 2007

Status Verified

September 1, 2007

First QC Date

February 21, 2007

Last Update Submit

September 19, 2007

Conditions

Keywords

CaregiversCaregivingSpousal relationshipscognition disorderstherapymental healthpsychosocial

Outcome Measures

Primary Outcomes (2)

  • Changes in dyadic (couple) adjustment

  • depression

Secondary Outcomes (2)

  • Level of anxiety

  • satisfaction with social support

Interventions

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Couples, in which one partner has been diagnosed with AD and is in the mild stage of the disease
  • Ages 21 to 90

You may not qualify if:

  • Severe psychological or physical illness
  • Unwillingness to participate in all aspects of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine

New York, New York, 10016, United States

RECRUITING

Related Publications (4)

  • Morrissey MV. Rethinking the benefits of an adapted version of 'Alzheimer Cafe' for individuals with Alzheimer's and their partners. Int J Psychiatr Nurs Res. 2006 Sep;12(1):1393-401.

    PMID: 17016901BACKGROUND
  • Robinson L, Clare L, Evans K. Making sense of dementia and adjusting to loss: psychological reactions to a diagnosis of dementia in couples. Aging Ment Health. 2005 Jul;9(4):337-47. doi: 10.1080/13607860500114555.

    PMID: 16019290BACKGROUND
  • Gallagher-Thompson D, Dal Canto PG, Jacob T, Thompson LW. A comparison of marital interaction patterns between couples in which the husband does or does not have Alzheimer's disease. J Gerontol B Psychol Sci Soc Sci. 2001 May;56(3):S140-50. doi: 10.1093/geronb/56.3.s140.

    PMID: 11316839BACKGROUND
  • Auclair U, Epstein C, Mittelman M. Couples Counseling in Alzheimer's Disease: Additional Clinical Findings from a Novel Intervention Study. Clin Gerontol. 2009 Apr 1;32(2):130-146. doi: 10.1080/07317110802676809.

    PMID: 19865591BACKGROUND

MeSH Terms

Conditions

Alzheimer DiseaseDementiaCognition DisordersPsychological Well-Being

Interventions

CounselingPalliative Care

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersPersonal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPatient CareTherapeutics

Study Officials

  • Mary S. Mittelman, DrPH

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2007

First Posted

February 22, 2007

Study Start

November 1, 2004

Study Completion

November 1, 2007

Last Updated

September 20, 2007

Record last verified: 2007-09

Locations