Preventing Anxiety and Depression in Older Hispanics

Not Applicable

Active, not recruiting

• Conditions: Depression; Anxiety
• Interventions: Behavioral: Healthy lifestyles education program; Behavioral: HOLA Component 1; Behavioral: HOLA Component 2; Behavioral: HOLA Component 3; Behavioral: HOLA Component 4

• Registration Number: NCT03870360
• Lead Sponsor: University of Miami

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-12
• Study Start: 2022-11-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 240

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HOLA: A Culturally-Tailored Health Promotion Intervention	HOLA Component 2	16 week, multicomponent, health promotion intervention
HOLA: A Culturally-Tailored Health Promotion Intervention	HOLA Component 3	16 week, multicomponent, health promotion intervention
Healthy lifestyles education program	Healthy lifestyles education program	Educational material on mental health, physical activity, and information on community resources
HOLA: A Culturally-Tailored Health Promotion Intervention	HOLA Component 1	16 week, multicomponent, health promotion intervention
HOLA: A Culturally-Tailored Health Promotion Intervention	HOLA Component 4	16 week, multicomponent, health promotion intervention

Primary Outcome Measures

Name	Time	Method
Incidence of generalized anxiety disorder	2 years	As measured by the Structured Clinical Interview for the Diagnostic and Statistical Manual 5th edition (SCID-5), a structured clinical interview used for diagnosis.
Recurrence of major depression disorder	2 years	As measured by the SCID-5, a structured clinical interview used for diagnosis.
Change in risk factors for major depressive disorder (MDD)	Baseline, 16 weeks, 6, 12, 18, and 24 months	As measured by the Beck Depression Inventory that has a range of scores from 0-63 with scores of 0-9 being minimal depression, 10-18 mild depression, 19-29 moderate depression, and 30-63 severe depression.
Change in risk factors for generalized anxiety disorder (GAD)	Baseline, 16 weeks, 6, 12, 18, and 24 months	As measured by the Beck Anxiety Inventory that has a range of scores from 0-63 with scores 0-21 low anxiety, 22-35 moderate anxiety, and 36+ potentially concerning levels
Incidence of major depression disorder	2 years	As measured by the SCID-5, a structured clinical interview used for diagnosis.
Recurrence of generalized anxiety disorder	2 years	As measured by the SCID-5, a structured clinical interview used for diagnosis.

Secondary Outcome Measures

Name	Time	Method
Change in anti-inflammatory markers	Baseline, 16 weeks, 12, and 24 months	Obtained from plasma samples
Change in pro-inflammatory markers	Baseline, 16 weeks, 12, and 24 months	Obtained from plasma samples
Change in physical functioning as measured by the physical performance battery	Baseline, 16 weeks, 6, 12, 18, and 24 months	The battery assesses static balance, leg strength, normal gait speed, and narrow walk for dynamic balance using the 6-minute walk test, the timed up and go test, and the gallon jug shelf transfer test.
Change in quality of life	Baseline, 16 weeks, 6, 12, 18, and 24 months	As measured by the Short Form Health Survey 12 (SF-12). The SF-12v2 is a measure of health related quality of life and provides 2 scores 1) Mental Component Summary Score (MCS) and 2) Physical Component Summary Score (PCS). MCS scores range from 0 to 100, higher scores indicate better mental health related quality of life.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States