Prevention and Treatment of Depression in the Elderly: A Population-Based Study

Study Overview
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Brief Summary
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Considering the rapid increase of the elderly population in Brazil and the growing impact of depression, the third cause of global burden of diseases in the world, the relevance of depression prevention and treatment in older people tend to raise in future years. The investigators planned to screen 2,700 individuals, 60 years and older, from Basic Health Units in the west region of Sao Paulo city, for subsyndromic depressive and / or anxiety symptoms. The elderly will be assessed with a standardized psychiatric interview to calculate the prevalence of subsyndromic symptoms of depression and / or anxiety and the prevalence of depressive and anxiety disorders. Those who do not meet criteria for depressive disorders and / or anxiety will be invited to participate in a randomized clinical trial with 2 arms: a stepped-care prevention program with physical activity (n = 35) or usual care (n = 35). The primary outcome measure will be the cumulative incidence of major depressive disorder, or anxiety disorders, after 12 months.

Official Title
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Prevention and Treatment of Depression in the Elderly: A Population-Based Study

Conditions
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Subsyndromic Symptoms of Depression, Subsyndromic Symptoms of Anxiety

Intervention / Treatment
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* Behavioral: Physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 60 years or older with subsyndromal symptoms of depression or anxiety, enrolled in one of the selected Project West Region UBS, who agree with the information presented in the free and informed consent term. A subject is defined as having subsyndromal symptoms of depression and / or anxiety, when he or she scores 13 or more on the CES-D scale, but does not meet criteria for a depressive or anxiety disorder, assessed by applying the Mini International Neuropsychiatric Interview (MINI) (Sheehan et al, 1998;. Marques de Azevedo and Zuardi, 2008). Exclusion Criteria: Those who meet criteria for major depression, dysthymia and / or anxiety disorders, or unable to consent to participate in this research project. All seniors will be interviewed in their homes.

Ages Eligible for Study
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Minimum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Physical activity<br>The assessment of physical activity in the prevention of depression. The intervention program being implemented in this study consists of four steps, lasting three months each: Step 1 - Watchful waiting Step 2 - Physical Activity Intervention 1 Step 3 - Physical Activity Intervention 2 Step 4 - Referral to primary care In the case of the CES-D scores remain high, participants will receive orientation to discuss with their doctors the need to receive a specific medication. | Behavioral: Physical activity<br> <br> |
| No Intervention: Usual care<br>Participants in the usual care group will have unrestricted access to usual care for depressive and / or anxiety symptoms. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of major depressive disorder, or anxiety disorders | The primary outcome measure will be the cumulative incidence of major depressive disorder, or anxiety disorders after 12 months (MINI, structured interview). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CES-D | Reducing depressive and / or anxiety symptoms, assessed with the CES-D | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Subsyndromic symptoms of depression, Subsyndromic symptoms of anxiety, Physical activity, Population-based study