BereavementNCT00001659
Consequences of Conjugal Bereavement in Adults
An observational study of Bereavement and Depressive Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bereavement, Depressive Disorder, Immunologic Disease
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1997to May 2002
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
People over the age of 50 who have lost their spouse within the last three months.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
Official title: Conjugal Bereavement in Older Adults: Biological, Functional, and Psychological Consequences
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.
Read more
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.
Read the 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.
- Keywords
- Bereavement, Depression, Suicide, Activity of Daily Living, Immune Function, Occupational Performance, Sleep Disorders, Mood Changes
- Medical subject headings
- Depressive Disorder, Immune System Diseases, Mental Disorders, Sleep Wake Disorders, Depression, Suicide
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startJul 1997
- Study completionMay 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BereavementStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 210 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001659
- Sponsor's protocol ID
- 970157
- Other IDs
- 97-M-0157
- Status last verified
- May 2002
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 8610165Reynolds 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.
PubMed 8580390Steffens 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.
PubMed 9099411
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conjugal Bereavement in Older Adults: Biological, Functional, and Psychological Consequences
- ClinicalTrials.gov ID
- NCT00001659
- Acronym / sponsor ID
- 970157
- Keywords
- Bereavement, Depression, Suicide, Activity of Daily Living, Immune Function, Occupational Performance, Sleep Disorders, Mood Changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Jul 1997
- Study completion
- May 2002
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8610165Kiecolt-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.
- Background: PubMed 8580390Reynolds 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.
- Background: PubMed 9099411Steffens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bereavement and Depressive Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001659, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.