Viewing Study NCT00001659



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Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00001659
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 1999-11-03

Brief Title: Consequences of Conjugal Bereavement in Adults
Sponsor: National Institute of Mental Health NIMH
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Conjugal Bereavement in Older Adults Biological Functional and Psychological Consequences
Status: COMPLETED
Status Verified Date: 2002-05
Last Known Status: None
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: Bereavement refers to the expected reactions and sadness associated with the loss of a loved one It has been reported that the loss of a spouse is rated as the major life stressor among survivors of varying ages and diverse cultural backgrounds Statistics have shown that in the United States over 800000 men and women lose a spouse each year

A wide range of symptoms has been associated with bereavement including depressed mood tearfulness sleep disturbances and irrational behavior Previous studies have shown that up to 50 of bereaved individuals can develop major depression Bereavement has also been associated with dysfunction of the immune system As a result bereaved adults are more vulnerable to infection However the exact relationship between bereavement and immunity is uncertain

Researchers firmly believe that a relationship does exist between stress more specifically bereavement immunity and the increased chance of dying following the loss of a long-term spouse

The objective of this study is to find possible links between bereavement depression and the immune system This study will follow a group of elderly bereaved spouses and a group of elderly people who have not lost a long-term spouse The group of bereaved individuals will be followed for approximately 13 months after the loss of their spouse and the group of controls will be followed for 13 months after entering the study Researchers will make note of any clinical biological and immunological changes in any participants of the study
Detailed Description: It is estimated that over 800000 men and women become bereaved each year in the United States LaRue et al 1985 While the near certainty of such bereavement is predictable in one spouse or the other the exact impact and duration of bereavement is much less predictable Stroebe et al 1995 It has been reported that the loss of a spouse is rated as the major life stressor among survivors of varying ages and diverse cultural backgrounds Holmes and Rahe 1967 As one copes with the loss of a loved one expected reactions include sadness tearfulness and even depression DeLeon 1994 Pasternak 1996 Other complications can include work-related difficulties sleep disturbances irrational behaviors and immunologic dysfunction Zisook 1994 Prigerson et al 1995 All of these symptoms are common yet the underlying biology and relationship with the time course of bereavement are still poorly understood The purpose of this study will be to prospectively follow a cohort of elderly bereaved spouses and controls from multiple clinical and biological perspectives over thirteen months after the loss of a spouse

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
97-M-0157 None None None