Depression, Anxiety
Conditions
Keywords
depression, aged, problem-solving
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
Interventions
BEHAVIORALVIDACTIVA 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)
BEHAVIORALStandard 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.
Sponsors
Universidad de San Martín de Porres
Asociacion Benefica Prisma
Johns Hopkins University
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
We will try to mask the outcome assessor, but for the nature of the intervention, it will be difficult that outcome assessor remain blind.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | From enrollment to the end of treatment at 14th week , 22th week | Measured by Patient Health Questionnaire - 9 (PHQ-9) \[ minimum score: 0 ; maximum score: 27 \] \[More score = worse symptoms\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Symptoms | From enrollment to the end of treatment at 14th week, and 22week | Measured by Generalised Anxiety Disorder - 7 (GAD-7) \[min score: 0 , max score: 21\] \[more score, worse symptoms\] |
| Loneliness | From enrollment to the end of treatment at 14th week, and 22 week | Measured by the Three-Items Loneliness \[min 0, max: 9\] \[more score, more lonely\] |
Countries
Peru
Contacts
PRINCIPAL_INVESTIGATOROscar Flores-Flores, MD, MSc
Universidad de San Martin de Porres
Participant flow
Recruitment details
Door by Door, and other community-based strategies.
Pre-assignment details
A total of 72 participants provided informed consent and underwent eligibility screening. Eight participants were excluded before randomization because they did not meet the eligibility criteria (PHQ9\<6). The remaining 64 participants were randomized.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 70.7 years STANDARD_DEVIATION 5.4 |
| anxiety symptoms (GAD-7) | 12.0 points STANDARD_DEVIATION 6 |
| depressive symptoms (PHQ-9) | 14.5 points STANDARD_DEVIATION 5.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| loneliness (TIL-3) | 6.2 points STANDARD_DEVIATION 1.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 64 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 33 |
| other Total, other adverse events | 0 / 31 | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 | 0 / 33 |
Outcome results
None listed