Primary Prevention of Major Depression in Later Life

Study Overview
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Brief Summary
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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
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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.

Official Title
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Primary Prevention of Major Depression in Later Life

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Problem Solving Therapy
* Behavioral: Dietary Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50 or greater Center for Epidemiological Studies of Depression Scale (CES-D) score of 11 or higher Folstein Mini-Mental State score of 24 or higher Not currently receiving antidepressant medication or participating in other mental health treatment Exclusion Criteria: Episode of major depression within the past 12 months Episode of alcohol or other substance abuse within the past 12 months Life time history of bipolar disorder or other psychotic disorder Diagnosis of any neurodegenerative disorder or of dementia (Alzheimer's, vascular, or frontotemporal dementia, etc.)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BDI, Hamilton, FDI scores, SCID diagnosis of major depression |  | Over the course of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CES-D, ISEL,Folstein Mini-Mental, MOS-SF8,BSI, EXIT, Hopkins Verbal Learning Test, PTSD Checklist, Social Problem Solving Inventory, PSQI, CIRS-G, RAND 12 |  | over the course of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression Prevention, Prevention of Depression, Depression in the Elderly, Late Life Depression, Depression in Old Age, Treatment of Depression in Primary Care Patients, Sub syndromal depression, Minor Depression