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

Not Applicable

Completed

• Conditions: Subsyndromic Symptoms of Depression; Subsyndromic Symptoms of Anxiety
• Interventions: Behavioral: Physical activity

• Registration Number: NCT03538873
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-13
• Study First Submitted: 2014-07-07
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-25
• Study First Posted: 2018-05-29
• Primary Completion: 2018-07-05
• Study Completion: 2018-07-05
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical activity	Physical activity	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.

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of major depressive disorder, or anxiety disorders	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 Outcome Measures

Name	Time	Method
CES-D	12 months	Reducing depressive and / or anxiety symptoms, assessed with the CES-D

Trial Locations

Locations (1)

Institute of Psychiatry, USaoPauloGH; 🇧🇷 Sao Paulo, Brazil