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

University of Sao Paulo General Hospital

Status: Completed

Conditions: Subsyndromic Symptoms of Anxiety; Subsyndromic Symptoms of Depression

Treatments: Behavioral: Physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT03538873

LLD10446

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Physical activity

Active Comparator group

Description:

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.

Treatment:

Behavioral: Physical activity

Usual care

No Intervention group

Description:

Participants in the usual care group will have unrestricted access to usual care for depressive and / or anxiety symptoms.