Depression, AnxietyVIDACTIVA1NCT06065020
Community Intervention to Improve Depressive Symptoms Among Older Adults (VIDACTIVA)
A study testing VIDACTIVA sessions in people with Depression, Anxiety, run by Universidad de San Martín de Porres at 1 site in Peru.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- VIDACTIVA sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePeru
- Study dates
- 23 Oct 2023to 3 Feb 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Previous diagnosis of bipolar disorder
- History of substance abuse
- History of dissociative disorder, psychosis or dementia, or moderate memory and/or cognition problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read the 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
- Conditions
- Depression, Anxiety
- Being tested
- VIDACTIVA sessions, Standard Care
- Keywords
- depression, aged, problem-solving
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIDACTIVA sessionsBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | VIDACTIVA program Receives: Behavioral: VIDACTIVA sessions |
| Control group | Active comparator | Standard Care Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptoms
Measured by Patient Health Questionnaire - 9 (PHQ-9) [ minimum score: 0 ; maximum score: 27 ] [More score = worse symptoms]
Measured: From enrollment to the end of treatment at 14th week , 22th week
Secondary outcomes (2)
Anxiety Symptoms
Measured by Generalised Anxiety Disorder - 7 (GAD-7) [min score: 0 , max score: 21] [more score, worse symptoms]
Measured: From enrollment to the end of treatment at 14th week, and 22week
Loneliness
Measured by the Three-Items Loneliness [min 0, max: 9] [more score, more lonely]
Measured: From enrollment to the end of treatment at 14th week, and 22 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start23 Oct 2023
- Primary completion3 Feb 2025
- Study completion3 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de San Martín de Porres
- Sponsor type
- University, hospital or other
- Collaborators
- Asociacion Benefica Prisma, Johns Hopkins University, University of Washington
- Responsible party
- Sponsor
- Investigators
- Oscar Flores-Flores, MD, MSc, Principal investigator, Universidad de San Martin de Porres
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065020
- Sponsor's protocol ID
- E10012021018
- Other IDs
- K43TW011586
- Acronym
- VIDACTIVA1
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2023
- Last updated
- 16 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once first manuscript using data is published.
Publications
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.
PubMed 39175082Otero-Oyague D, Lastra Landa 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. BMC Health Serv Res. 2026 Feb 21;26(1):418. doi: 10.1186/s12913-026-14130-z.
PubMed 41723436Otero-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.
PubMed 41282139