Clinical trial NCT06065020: Community Intervention to Improve Depressive Symptoms Among Older Adults (VIDACTIVA)
Official title: Pilot Trial of an Evidence-based Community Intervention to Improve Depressive Symptoms Among Peruvian Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Keywords: depression
aged
problem-solving
Lead sponsor: Universidad de San Martín de Porres
Sponsor class: OTHER
Collaborators: name: Asociacion Benefica Prisma
name: Johns Hopkins University
name: University of Washington
First posted: 2023-10-03
Enrollment: 64
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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?

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

Eligibility criteria: 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.

Primary outcomes:
measure: Depressive symptoms
timeFrame: At baseline, at 14th and 22th week.
Secondary outcomes:
measure: Anxiety symptoms
timeFrame: At baseline, at 14th and 22th week.
measure: Loneliness
timeFrame: At baseline, at 14th and 22th week.
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Universidad de San Martin de Porres
Study officials:
affiliation: Universidad de San Martin de Porres
name: Oscar Flores-Flores, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: