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

May 19, 2022 updated by: University of Sao Paulo General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403010
        • Institute of Psychiatry, USaoPauloGH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: Physical activity
No Intervention: Usual care
Participants in the usual care group will have unrestricted access to usual care for depressive and / or anxiety symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Cassio MC Bottino, MD, PhD, University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2013

Primary Completion (Actual)

July 5, 2018

Study Completion (Actual)

July 5, 2018

Study Registration Dates

First Submitted

July 7, 2014

First Submitted That Met QC Criteria

May 25, 2018

First Posted (Actual)

May 29, 2018

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LLD10446

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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