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Consequences of Conjugal Bereavement in Adults

Primary Purpose

Bereavement, Depressive Disorder, Immunologic Disease

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Mental Health (NIMH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Bereavement focused on measuring Bereavement, Depression, Suicide, Activity of Daily Living, Immune Function, Occupational Performance, Sleep Disorders, Mood Changes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

People over the age of 50 who have lost their spouse within the last three months.

Sites / Locations

  • National Institute of Mental Health (NIMH)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00001659
Brief Title
Consequences of Conjugal Bereavement in Adults
Official Title
Conjugal Bereavement in Older Adults: Biological, Functional, and Psychological Consequences
Study Type
Observational

2. Study Status

Record Verification Date
May 2002
Overall Recruitment Status
Completed
Study Start Date
July 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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 800,000 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 800,000 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bereavement, Depressive Disorder, Immunologic Disease, Mental Disorder, Sleep Disorder
Keywords
Bereavement, Depression, Suicide, Activity of Daily Living, Immune Function, Occupational Performance, Sleep Disorders, Mood Changes

7. Study Design

Enrollment
210 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
People over the age of 50 who have lost their spouse within the last three months.
Facility Information:
Facility Name
National Institute of Mental Health (NIMH)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8610165
Citation
Kiecolt-Glaser JK, Glaser R, Gravenstein S, Malarkey WB, Sheridan J. Chronic stress alters the immune response to influenza virus vaccine in older adults. Proc Natl Acad Sci U S A. 1996 Apr 2;93(7):3043-7. doi: 10.1073/pnas.93.7.3043.
Results Reference
background
PubMed Identifier
8580390
Citation
Reynolds CF 3rd, Frank E, Perel JM, Mazumdar S, Kupfer DJ. Maintenance therapies for late-life recurrent major depression: research and review circa 1995. Int Psychogeriatr. 1995;7 Suppl:27-39. doi: 10.1017/s104161029500233x.
Results Reference
background
PubMed Identifier
9099411
Citation
Steffens DC, Plassman BL, Helms MJ, Welsh-Bohmer KA, Saunders AM, Breitner JC. A twin study of late-onset depression and apolipoprotein E epsilon 4 as risk factors for Alzheimer's disease. Biol Psychiatry. 1997 Apr 15;41(8):851-6. doi: 10.1016/S0006-3223(96)00247-8.
Results Reference
background

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Consequences of Conjugal Bereavement in Adults

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