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

NCT03538873 | Completed DMC

• 1 other identifier: LLD10446
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Subsyndromic Symptoms of Depression; Subsyndromic Symptoms of Anxiety

Keywords

Subsyndromic symptoms of depression; Subsyndromic symptoms of anxiety; Elderly; Physical activity; Population-based study

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months

Secondary Outcomes (1)

• CES-D

  12 months

Study Arms (2)

Physical activity

ACTIVE COMPARATOR

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

Usual care

NO INTERVENTION

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

Interventions

Physical activity BEHAVIORAL

Physical activity

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Institute of Psychiatry, USaoPauloGH

São Paulo, 05403010, Brazil

Location

Related Publications (4)

• 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.

  PMID: 16428253 BACKGROUND

• 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.

  PMID: 19255379 BACKGROUND

• 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.

  PMID: 9881538 BACKGROUND

• 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.

  PMID: 18585532 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Cassio MC Bottino, MD, PhD

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: May 29, 2018
• Study Start: November 13, 2013
• Primary Completion: July 5, 2018
• Study Completion: July 5, 2018
• Last Updated: May 26, 2022

Record last verified: 2018-05

Locations

BR (1)