Preventing Anxiety and Depression in Older Hispanics

NCT03870360 | Active Not Recruiting DMC

• 2 other identifiers: 20180816R01MD012610
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety

Outcome Measures

Primary Outcomes (6)

• Change in risk factors for major depressive disorder (MDD)

  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.

  Baseline, 16 weeks, 6, 12, 18, and 24 months

• Change in risk factors for generalized anxiety disorder (GAD)

  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

  Baseline, 16 weeks, 6, 12, 18, and 24 months

• Incidence of generalized anxiety disorder

  As measured by the Structured Clinical Interview for the Diagnostic and Statistical Manual 5th edition (SCID-5), a structured clinical interview used for diagnosis.

  2 years

• Recurrence of generalized anxiety disorder

  As measured by the SCID-5, a structured clinical interview used for diagnosis.

  2 years

• Incidence of major depression disorder

  As measured by the SCID-5, a structured clinical interview used for diagnosis.

  2 years

• Recurrence of major depression disorder

  As measured by the SCID-5, a structured clinical interview used for diagnosis.

  2 years

Secondary Outcomes (4)

• Change in pro-inflammatory markers

  Baseline, 16 weeks, 12, and 24 months

• Change in anti-inflammatory markers

  Baseline, 16 weeks, 12, and 24 months

• Change in physical functioning as measured by the physical performance battery

  Baseline, 16 weeks, 6, 12, 18, and 24 months

• Change in quality of life

  Baseline, 16 weeks, 6, 12, 18, and 24 months

Study Arms (2)

HOLA: A Culturally-Tailored Health Promotion Intervention

EXPERIMENTAL

16 week, multicomponent, health promotion intervention

Behavioral: HOLA Component 1; Behavioral: HOLA Component 2; Behavioral: HOLA Component 3; Behavioral: HOLA Component 4

Healthy lifestyles education program

ACTIVE COMPARATOR

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

Behavioral: Healthy lifestyles education program

Interventions

HOLA Component 1 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: A Culturally-Tailored Health Promotion Intervention

HOLA Component 2 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: A Culturally-Tailored Health Promotion Intervention

HOLA Component 3 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: A Culturally-Tailored Health Promotion Intervention

HOLA Component 4 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.

HOLA: A Culturally-Tailored Health Promotion Intervention

Healthy lifestyles education program BEHAVIORAL

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

Healthy lifestyles education program

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Miami: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Daniel E. Jimenez, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 12, 2019
• Study Start: November 1, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)