Community Intervention to Improve Depressive Symptoms Among Older Adults (VIDACTIVA) (VIDACTIVA1)

Pilot Trial of an Evidence-based Community Intervention to Improve Depressive Symptoms Among Peruvian Older Adults

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?

Study Overview

• Status: Recruiting
• Conditions: Depression, Anxiety
• Intervention / Treatment: Behavioral: VIDACTIVA sessions; Behavioral: Standard Care

Detailed Description

Participants who join will be split into two groups: one group will get the interventional program, and the other group will get standard care. In the interventional group, community health workers will meet with participants eight times to do activities and talk about how they feel. The standard group will have two visits where they will learn things about mental health.

The results of the study will help the researchers understand whether they can test the program in larger study. Additionally, see whether those participants in the interventional group feel better than those who are in the standard group.

Sample size: This is a pilot trial. No sample size calculations are needed because the objective is NOT to evaluate the effect of the intervention, but rather the feasibility of conducting a large-scale clinical trial. It is expected to enroll 64 participants (32 control group vs 32 intervention group). This number is based on previous formative study and training of community health workers.

Researchers will collect basic information to assess feasibility for a larger trial, including:

• Number of potential participants screened per month;
• Number of participants enroled per month;
• Average time from enrolment to randomisation.
• Average time to reach enrolment goal
• Proportion of eligible participants who enrol
• Proportion of people who maintain the study in both groups.
• Reasons for abandoning the study.
• Visit durations

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oscar Flores-Flores, MD, MSc; Phone Number: +51934901717; Email: ofloresf@usmp.pe
• Study Contact Backup: Name: Diego Otero-Oyague, MS; Email: diego.otero@pucp.pe

Study Locations

• Peru
  • Lima, Peru
    • Recruiting
    • Universidad de San Martin de Porres
    • Contact: Vanessa Patiño, BA
    • Sub-Investigator: Diego Otero-Oyague

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; VIDACTIVA program	Behavioral: VIDACTIVA sessions; 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)
Active Comparator: Control group; Standard Care	Behavioral: Standard Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety symptoms	Measured by Generalised Anxiety Disorder - 7 (GAD-7) [min score: 0 , max score: 21] [more score, worse symptoms]	At baseline, at 14th and 22th week.
Loneliness	Measured by the Three-Items Loneliness [min 0, max: 9] [more score, more lonely]	At baseline, at 14th and 22th week.

Collaborators and Investigators

• Sponsor: Universidad de San Martín de Porres
• Collaborators: Johns Hopkins University; University of Washington; Asociacion Benefica Prisma
• Investigators: Principal Investigator: Oscar Flores-Flores, MD, MSc, Universidad de San Martin de Porres

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Actual): October 3, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 28, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: depression; aged; problem-solving
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: E10012021018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Once first manuscript using data is published.
• IPD Sharing Time Frame: Expected to be available, once first manuscript is published. Expected 2025. For the next five years (2030).
• IPD Sharing Access Criteria: We will share data based on reasonable request of a researcher.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No