Status:
ACTIVE_NOT_RECRUITING
Preventing Anxiety and Depression in Older Hispanics
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Institute on Minority Health and Health Disparities (NIMHD)
Conditions:
Depression
Anxiety
Eligibility:
All Genders
60+ years
Phase:
NA
Brief 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...
Detailed Description
Given the prevalence and morbidity of depression in later life, the inadequacies of current treatment approaches for averting years living with disability, the inequities in access to the mental healt...
Eligibility Criteria
Inclusion
- 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
- 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 current tobacco smokers since smoking influences systemic inflammation;
- Have contraindications to physical activity outlined in the American College of Sports Medicine standards;
- Have high suicide risk, i.e., intent or plan to attempt suicide in the near future (a response of "yes" to questions 3, 4, and/or 5 on the Paykel Questionnaire;
- Are unable to complete 10 m walk test;
- Currently residing in a nursing or group home;
- Have a terminal physical illness expected to result in the death within one year;
- Any evidence of current infection; and
- Have an acute or severe medical illness that precludes them from safely participating in a health promotion intervention (further defined in the protocol).
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03870360
Start Date
November 1 2022
End Date
June 1 2026
Last Update
November 26 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136