Preventing Anxiety and Depression in Older Hispanics

NCT ID: NCT03870360

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2026-06-01

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.

Conditions

Depression; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

HOLA: A Culturally-Tailored Health Promotion Intervention

16 week, multicomponent, health promotion intervention

Group Type: EXPERIMENTAL

HOLA Component 1

Intervention Type: BEHAVIORAL

At week 1 and week 8 participants will meet individually with Community Health Worker (CHW) for 30 minutes for a manualized social and physical activation session.

HOLA Component 2

Intervention Type: BEHAVIORAL

A CHW led 45 minute (10 minutes of stretching and warm up, followed by 30 minutes of walking with a 5 minute cool down) group walk session of six participants at a time done 3 times a week that utilized interval training that slowly gradually increases in intensity.

HOLA Component 3

Intervention Type: BEHAVIORAL

A CHW led pleasant event discussion, asking each participant to identify a pleasant event. This task is done in conjunction with the cool down of HOLA 2.

HOLA Component 4

Intervention Type: BEHAVIORAL

One booster walking session twice a month for six months post intervention for reinforcement, then one booster walking session a month for eighteen months.

Healthy lifestyles education program

Educational material on mental health, physical activity, and information on community resources

Group Type: ACTIVE_COMPARATOR

Healthy lifestyles education program

Intervention Type: BEHAVIORAL

Biweekly telephone check in calls for the first 16 weeks followed by monthly check in calls during the two year follow up period.

Interventions

HOLA Component 1

At week 1 and week 8 participants will meet individually with Community Health Worker (CHW) for 30 minutes for a manualized social and physical activation session.

Intervention Type: BEHAVIORAL

HOLA Component 2

A CHW led 45 minute (10 minutes of stretching and warm up, followed by 30 minutes of walking with a 5 minute cool down) group walk session of six participants at a time done 3 times a week that utilized interval training that slowly gradually increases in intensity.

Intervention Type: BEHAVIORAL

HOLA Component 3

A CHW led pleasant event discussion, asking each participant to identify a pleasant event. This task is done in conjunction with the cool down of HOLA 2.

Intervention Type: BEHAVIORAL

HOLA Component 4

One booster walking session twice a month for six months post intervention for reinforcement, then one booster walking session a month for eighteen months.

Intervention Type: BEHAVIORAL

Healthy lifestyles education program

Biweekly telephone check in calls for the first 16 weeks followed by monthly check in calls during the two year follow up period.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Responsible Party

Daniel Enrique Jimenez

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel E. Jimenez, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

R01MD012610

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20180816

Identifier Type: -

Identifier Source: org_study_id