Trials / Completed
CompletedNCT00326677
Primary Prevention of Major Depression in Later Life
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 306 (actual)
- Sponsor
- University of Maryland, College Park · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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.
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 (e.g., 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Problem Solving Therapy | 6 to 8 Problem Solving Therapy sessions over the course of 6 to 16 weeks followed by 3 booster PST sessions over the course of 2 years |
| BEHAVIORAL | Dietary Education | 6 to 8 Diet Education sessions over the course of 6 to 16 weeks followed by 3 booster Diet Education sessions over the course of 2 years |
Timeline
- Start date
- 2006-05-01
- Primary completion
- 2012-12-01
- Completion
- 2013-12-01
- First posted
- 2006-05-17
- Last updated
- 2025-01-15
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00326677. Inclusion in this directory is not an endorsement.