Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00326677
Status:
UNKNOWN
Last Update Posted:
2011-02-18
First Post:
2006-05-15
Brief Title:
Primary Prevention of Major Depression in Later Life
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Primary Prevention of Major Depression in Later Life
Status:
UNKNOWN
Status Verified Date:
2011-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The Institute of Medicine has called for studies of indicated preventive interventions to reduce the incidence of mental illness in persons already symptomatic but not yet presenting with fully developed clinical syndromes
The investigators Advanced Center for Interventions and Services Research in Late Life Mood Disorders has embraced the development and testing of preventive interventions as one of its key objectives The investigators propose to test the following hypotheses related to primary prevention of major depressive episodes in old age focusing on elderly patients who have symptoms of emotional distress but who are not yet presenting with the full syndrome of a major depressive episode
Hypothesis 1 Problem solving therapy PST will be superior to an attention-only control dietary education in lowering the two-year incidence of episodes of syndromal major depression in already symptomatic elderly primary care patients
Hypothesis 2 PST will also prevent higher levels of depressive symptoms and associated disabilities over a two-year period of follow-up
The investigators Advanced Center for Interventions and Services Research in Late Life Mood Disorders has embraced the development and testing of preventive interventions as one of its key objectives The investigators propose to test the following hypotheses related to primary prevention of major depressive episodes in old age focusing on elderly patients who have symptoms of emotional distress but who are not yet presenting with the full syndrome of a major depressive episode
Hypothesis 1 Problem solving therapy PST will be superior to an attention-only control dietary education in lowering the two-year incidence of episodes of syndromal major depression in already symptomatic elderly primary care patients
Hypothesis 2 PST will also prevent higher levels of depressive symptoms and associated disabilities over a two-year period of follow-up
Detailed Description:
306 participants will be randomly assigned to either problem solving therapy or to a dietary education control PST will consist of 6 to 8 sessions distributed over 6 to 16 weeks teaching participants a structured process of problem definition generation of potential solutions evaluation and choice of solution and its implementation The dietary education control will consist of 6 to 8 sessions also distributed over 6 to 16 weeks Subjects assigned to the DIET condition will receive education in healthy eating practices eg food pyramid types of food and calories recommended for people age 60 and above tips on shopping for healthy food food preparation and healthy eating behavior Subjects will be followed up to 2 years Length of study is 24 months
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