Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT03870360
Eligibility Criteria:
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 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT03870360
Study Brief:
Protocol Section:
NCT03870360