Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2025-12-30 @ 11:01 PM
Study NCT ID:
NCT01244295
Status:
COMPLETED
Last Update Posted:
2014-01-16
First Post:
2010-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Interpersonal Therapy and Complicated Grief Treatment in Adults 50 Years and Older
Sponsor:
New York State Psychiatric Institute
Organization:
Study Overview
Official Title:
Complicated Grief Treatment in Older Adults
Status:
COMPLETED
Status Verified Date:
2014-01
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:
CGTOA
Brief Summary:
A comparison study of 16 week treatment with either specialized psychotherapy for complicated grief (CGT) or with standard interpersonal psychotherapy (IPT) in older adults with complicated grief.
Detailed Description:
According to the National Council on Aging (1), in 2005, there were more than 10 million older Americans who were widowed (8.6 million women (43%) and 2.1 million men (14%) over the age of 65). These people are at risk for a debilitating reaction called Traumatic or Complicated Grief (CG: the term now used for this condition). Studies confirm that Complicated Grief can be reliably identified and occurs in about 10-20% of bereaved individuals. CG appears to carry much of the risk for negative outcomes of bereavement. CG can affect health status and influence decisions about personal health care. The risk of hypertension is 10 times greater among widowed subjects who meet consensus criteria for CG compared to those who do not, while subjects with CG are 17 times less likely to have visited a physician in the months since the death. Despite its high prevalence and significant morbidity, there are no proven efficacious treatments. The PI of this project developed a novel psychotherapy called Complicated Grief Treatment (CGT), and has now completed a study (MH60783) comprised of adults over age 18, that confirmed efficacy of this approach. Participants ≥ age 60 (n=29) were less likely to be employed and more likely to live alone. We observed better response to CGT than IPT, as in younger adults. However, confirmation of efficacy among seniors is important, since older people have different vulnerabilities and different problems in adjusting to grief than younger adults. We plan to conduct a randomized controlled study of CGT v IPT in individuals \> 50 years of age who meet criteria for complicated grief and have no contraindications to study participation. Our specific aims are: 1) To compare results of 16 sessions of either CGT or standard IPT. We hypothesize that CGT will produce a higher response rate and shorter time to response than IPT, and that responders will show significantly greater reduction in associated symptoms and impairment than non-responders.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01MH070741 | NIH | None | https://reporter.nih.gov/quic… | View |