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

Depression, Anxiety Clinical Trial

— VIDACTIVA1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06065020
• Other study ID #: E10012021018
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Universidad de San Martín de Porres
• Contact: Oscar Flores-Flores, MD, MSc
• Phone: +51934901717
• Email: ofloresf[@]usmp.pe
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety

Intervention

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)
• 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.

Locations

Country	Name	City	State
Peru	Universidad de San Martin de Porres	Lima

Sponsors (4)

Lead Sponsor	Collaborator
Universidad de San Martín de Porres	Asociacion Benefica Prisma, Johns Hopkins University, University of Washington

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Loneliness	Measured by the Three-Items Loneliness [min 0, max: 9] [more score, more lonely]	At baseline, at 14th and 22th week.