VIDACTIVA1: Pilot Trial: Community Intervention to Improve Depressive Symptoms Among Older Adults(VIDACTIVA)
Study Details
Study Description
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?
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 us understand whether we can test the program in larger study, and preliminary see whether those 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 our formative study and training of community health workers.
We collect basic information to assess feasibility for a larger trial, including:
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Number of potential participants screened per month;
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Number of enrollees per month;
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Average time from enrollment to randomization.
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Average time to reach enrollment goal
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Proportion of eligible participants who enroll
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Proportion of people who maintain the study in both groups.
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Reasons for abandoning the study.
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Visit durations
Study Design
Arms and Interventions
| 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)
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| 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 referal to mental health community services (primary care centers). One session after the enrolment (week 1) and one at the 14th week.
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Outcome Measures
Primary Outcome Measures
- Depressive symptoms [At baseline, at 14th and 22th week.]
Measured by Patient Health Questionnaire - 9 (PHQ-9)
Secondary Outcome Measures
- Anxiety symptoms [At baseline, at 14th and 22th week.]
Measured by Generalized Anxiety Disorder - 7 (GAD-7)
- Loneliness [At baseline, at 14th and 22th week.]
Measured by the Three-Items Loneliness
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults ≥ 60 years old with the capacity to give consent, who are older adults with physical and mental autonomy.
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Current and constant residence in Villa El Salvador, Lima, Peru.
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Have depressive symptoms (score equal to or greater than 6 on the Patient Health Questionnaire - PHQ 9).
Exclusion Criteria:
Older Adults who have a previous diagnosis of bipolar disorder, history of substance abuse, dissociative disorder, psychosis or dementia, or moderate memory and/or cognition problems.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Universidad de San Martín de Porres
- Asociacion Benefica Prisma
- Johns Hopkins University
- University of Washington
Investigators
- Principal Investigator: Oscar Flores-Flores, MD, MSc, Universidad de San Martin de Porres
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E10012021018