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

Primary Purpose

Subsyndromic Symptoms of Depression, Subsyndromic Symptoms of Anxiety

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Physical activity
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Subsyndromic Symptoms of Depression focused on measuring Subsyndromic symptoms of depression, Subsyndromic symptoms of anxiety, Elderly, Physical activity, Population-based study

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Psychiatry, USaoPauloGH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Physical activity

Usual care

Arm 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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
July 7, 2014
Last Updated
May 19, 2022
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03538873
Brief Title
"Prevention and Treatment of Depression in the Elderly: A Population-Based Study"
Official Title
"Prevention and Treatment of Depression in the Elderly: A Population-Based Study"
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 13, 2013 (Actual)
Primary Completion Date
July 5, 2018 (Actual)
Study Completion Date
July 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subsyndromic Symptoms of Depression, Subsyndromic Symptoms of Anxiety
Keywords
Subsyndromic symptoms of depression, Subsyndromic symptoms of anxiety, Elderly, Physical activity, Population-based study

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical activity
Arm Type
Active Comparator
Arm 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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants in the usual care group will have unrestricted access to usual care for depressive and / or anxiety symptoms.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Primary Outcome Measure Information:
Title
Cumulative incidence of major depressive disorder, or anxiety disorders
Description
The primary outcome measure will be the cumulative incidence of major depressive disorder, or anxiety disorders after 12 months (MINI, structured interview).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
CES-D
Description
Reducing depressive and / or anxiety symptoms, assessed with the CES-D
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cassio MC Bottino, MD, PhD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Psychiatry, USaoPauloGH
City
Sao Paulo
ZIP/Postal Code
05403010
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
16428253
Citation
Hunkeler EM, Katon W, Tang L, Williams JW Jr, Kroenke K, Lin EH, Harpole LH, Arean P, Levine S, Grypma LM, Hargreaves WA, Unutzer J. Long term outcomes from the IMPACT randomised trial for depressed elderly patients in primary care. BMJ. 2006 Feb 4;332(7536):259-63. doi: 10.1136/bmj.38683.710255.BE. Epub 2006 Jan 20.
Results Reference
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PubMed Identifier
19255379
Citation
van't Veer-Tazelaar PJ, van Marwijk HW, van Oppen P, van Hout HP, van der Horst HE, Cuijpers P, Smit F, Beekman AT. Stepped-care prevention of anxiety and depression in late life: a randomized controlled trial. Arch Gen Psychiatry. 2009 Mar;66(3):297-304. doi: 10.1001/archgenpsychiatry.2008.555.
Results Reference
background
PubMed Identifier
9881538
Citation
Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
Results Reference
background
PubMed Identifier
18585532
Citation
de Azevedo Marques JM, Zuardi AW. Validity and applicability of the Mini International Neuropsychiatric Interview administered by family medicine residents in primary health care in Brazil. Gen Hosp Psychiatry. 2008 Jul-Aug;30(4):303-10. doi: 10.1016/j.genhosppsych.2008.02.001.
Results Reference
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"Prevention and Treatment of Depression in the Elderly: A Population-Based Study"

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