Clinical trial NCT03870360: Preventing Anxiety and Depression in Older Hispanics
Official title: Health Promotion in the Prevention of Anxiety and Depression: the Happy Older Latinos Are Active (HOLA Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2019-03-12
Enrollment: 240
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 either a health promotion intervention or a healthy lifestyles education program.

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 health care delivery system, and the workforce shortages to meet the mental health needs of older Latinos, development and testing of innovative strategies to prevent depression and anxiety are of great public health significance and have the potential to change practice.

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).

Primary outcomes:
measure: Change in risk factors for major depressive disorder (MDD)
timeFrame: Baseline, 16 weeks, 6, 12, 18, and 24 months
measure: Change in risk factors for generalized anxiety disorder (GAD)
timeFrame: Baseline, 16 weeks, 6, 12, 18, and 24 months
measure: Incidence of generalized anxiety disorder
timeFrame: 2 years
measure: Recurrence of generalized anxiety disorder
timeFrame: 2 years
measure: Incidence of major depression disorder
timeFrame: 2 years
measure: Recurrence of major depression disorder
timeFrame: 2 years
Secondary outcomes:
measure: Change in pro-inflammatory markers
timeFrame: Baseline, 16 weeks, 12, and 24 months
measure: Change in anti-inflammatory markers
timeFrame: Baseline, 16 weeks, 12, and 24 months
measure: Change in physical functioning as measured by the physical performance battery
timeFrame: Baseline, 16 weeks, 6, 12, 18, and 24 months
measure: Change in quality of life
timeFrame: Baseline, 16 weeks, 6, 12, 18, and 24 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Daniel E. Jimenez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: