Preventing Anxiety and Depression in Older Hispanics (NCT03870360) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Preventing Anxiety and Depression in Older Hispanics
United States240 participantsStarted 2022-11-01
Plain-language summary
The purpose of this study is to look at the best ways to prevent anxiety and depression in older Latino adults who are at risk for developing anxiety and depression. Participants will be randomized to either a health promotion intervention or a healthy lifestyles education program.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Latino (self-identified);
* Age 60+;
* Subthreshold depression defined as a score ≥ 5 on the Patient Health Questionnaire (PHQ-9), OR subthreshold anxiety as defined as a score ≥ 5 on the GAD-7;
* Do not meet criteria for current MDD or GAD as indicated by the Mini International Neuropsychiatric Inventory (MINI);
* Voluntary informed consent for participation in the study by the participant or by the participant's legally designated guardian or conservator;
* Medical clearance for participation in a health promotion intervention by a physician, physician's assistant, or nurse practitioner;
* Not taking steroidal or anti-inflammatory medication (including NSAIDs) within 2 weeks of treatment randomization;
* Expect to be resident in Miami for the subsequent 2 years.
Exclusion Criteria:
* Have met criteria for major depressive disorder or generalized anxiety disorder within the past 12 months;
* Have met criteria for alcohol or other substance abuse disorders within the past 12 months;
* Are currently receiving antidepressant medication or participating in other mental health treatment;
* Have a lifetime history of bipolar disorder or other psychotic disorder including major depression with psychotic features;
* Have a diagnosis of any neurodegenerative disorder or dementia (Parkinson's disease, Alzheimer's, vascular, frontotemporal dementia, etc.) or significant cognitive impairment as indicated by a Mini Mental Status Exam (MMSE) score \<24;
* Are curr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in risk factors for major depressive disorder (MDD)
Timeframe: Baseline, 16 weeks, 6, 12, 18, and 24 months
2
Change in risk factors for generalized anxiety disorder (GAD)
Timeframe: Baseline, 16 weeks, 6, 12, 18, and 24 months