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Completed

NCT Number: NCT03538873

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

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.

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Key information

Conditions

Subsyndromic Symptoms of Depression Behavior Motor Activity Subsyndromic Symptoms of Anxiety

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Psychiatry, USaoPauloGH

São Paulo, 05403010, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical activity

Behavioral

Primary outcomes

  1. Cumulative incidence of major depressive disorder, or anxiety disorders

    Time frame: 12 months

    The primary outcome measure will be the cumulative incidence of major depressive disorder, or anxiety disorders after 12 months (MINI, structured interview).

Secondary outcomes

  1. CES-D

    Time frame: 12 months

    Reducing depressive and / or anxiety symptoms, assessed with the CES-D

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
May 29, 2018
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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