Community Intervention to Improve Depressive Symptoms Among Older Adults (VIDACTIVA)

NCT06065020 | Completed

• 1 other identifier: E10012021018
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot trial is to test how feasible is to conduct a large clinical trial that evaluate both implementation and effectiveness outcomes of a community-based interventions for older adults with depression in low-resource urban settings from Lima, Peru. The main questions: Is the way we are planning the study, including those who are taking part and what they will do, good for a large study? Is the interventional package we are developing good the way it is, and can it be done the way we planned it?

Conditions

Depression, Anxiety

Keywords

depression; aged; problem-solving

Outcome Measures

Primary Outcomes (1)

• Depressive symptoms

  Measured by Patient Health Questionnaire - 9 (PHQ-9) \[ minimum score: 0 ; maximum score: 27 \] \[More score = worse symptoms\]

  At baseline, at 14th and 22th week.

Secondary Outcomes (2)

• Anxiety symptoms

  At baseline, at 14th and 22th week.

• Loneliness

  At baseline, at 14th and 22th week.

Study Arms (2)

Intervention group

EXPERIMENTAL

VIDACTIVA program

Behavioral: VIDACTIVA sessions

Control group

ACTIVE COMPARATOR

Standard Care

Behavioral: Standard Care

Interventions

VIDACTIVA sessions BEHAVIORAL

Community health workers (CHWs) will delivered VIDACTIVA intervention that consists in 8 home-sessions, one hour duration, within a period of 14 weeks + 2 follow-up calls (monthly). In total, a period of 22 weeks. The multicomponent intervention consist in the following: Problem-Solving Exercises: These are basic structured exercises aimed at training older individuals in problem-solving. This activity is centered around the older adult, meaning the older adults guides this activity, and the CHWs is a facilitator. Physical Activation: This component involves planning and "scheduling" enjoyable activities (physical or social) that the older adult chooses based on their preferences and capabilities. Education on Depressive Symptoms (psychoeducation)

Intervention group

Standard Care BEHAVIORAL

Study fieldworkers will provide 2 educational sessions (45-60 min) about mental health at old age and participant will be guided to mental health community services (primary care centers). One session after the enrolment (week 1) and one at the 14th week.

Control group

Eligibility Criteria

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

You may qualify if:

• Having depressive symptoms (score equal to or greater than 6 on the Patient Health Questionnaire - PHQ 9).
• Capacity to give consent.
• Current residence in Villa El Salvador, Lima, Peru.

You may not qualify if:

• Previous diagnosis of bipolar disorder
• History of substance abuse
• History of dissociative disorder, psychosis or dementia, or moderate memory and/or cognition problems.

Sponsors & Collaborators

• Universidad de San Martín de Porres: lead
• Asociacion Benefica Prisma: collaborator
• Johns Hopkins University: collaborator
• University of Washington: collaborator

Study Sites (1)

Universidad de San Martin de Porres

Lima, Lima Province, Peru

Location

Related Publications (2)

• Otero-Oyague D, Lastra D, Patino V, Carrion I, Cruz-Riquelme T, Pollard SL, Parodi JF, Steinman L, Gallo JJ, Valle R, Castro N, Flores-Flores O. Community health workers fostering trust and engagement in a community-based intervention for depressive older adults in Peru: a qualitative study. Res Sq [Preprint]. 2025 Oct 19:rs.3.rs-7665993. doi: 10.21203/rs.3.rs-7665993/v1.

  PMID: 41282139 DERIVED

• Cruz-Riquelme T, Zevallos-Morales A, Carrion I, Otero-Oyague D, Patino V, Lastra D, Valle R, Parodi JF, Pollard SL, Steinman L, Gallo JJ, Flores-Flores O. Pilot trial protocol: community intervention to improve depressive symptoms among Peruvian older adults. Pilot Feasibility Stud. 2024 Aug 22;10(1):112. doi: 10.1186/s40814-024-01540-1.

  PMID: 39175082 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Oscar Flores-Flores, MD, MSc

  Universidad de San Martin de Porres

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: We will try to mask the outcome assessor, but for the nature of the intervention, it will be difficult that outcome assessor remain blind.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Study Start: October 23, 2023
• Primary Completion: February 3, 2025
• Study Completion: February 3, 2025
• Last Updated: February 20, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Expected to be available, once first manuscript is published. Expected 2025. For the next five years (2030).
• Access Criteria: We will share data based on reasonable request of a researcher.

Locations

PE (1)