HOLA Component 4 for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Depression+3 More
HOLA Component 4 - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare two different approaches for preventing anxiety and depression in older Latinos at risk for developing these conditions.

Eligible Conditions
  • Depression
  • Anxiety

Treatment Effectiveness

Study Objectives

6 Primary · 4 Secondary · Reporting Duration: 2 years

2 years
Incidence of generalized anxiety disorder
Incidence of major depression disorder
Recurrence of generalized anxiety disorder
Recurrence of major depression disorder
Month 24
Change in anti-inflammatory markers
Change in pro-inflammatory markers
Month 24
Change in physical functioning as measured by the physical performance battery
Change in quality of life
Change in risk factors for generalized anxiety disorder (GAD)
Change in risk factors for major depressive disorder (MDD)

Trial Safety

Trial Design

2 Treatment Groups

Healthy lifestyles education program
1 of 2
HOLA: A Culturally-Tailored Health Promotion Intervention
1 of 2

Active Control

Experimental Treatment

240 Total Participants · 2 Treatment Groups

Primary Treatment: HOLA Component 4 · No Placebo Group · N/A

HOLA: A Culturally-Tailored Health Promotion InterventionExperimental Group · 4 Interventions: HOLA Component 3, HOLA Component 4, HOLA Component 2, HOLA Component 1 · Intervention Types: Behavioral, Behavioral, Behavioral, Behavioral
Healthy lifestyles education program
Behavioral
ActiveComparator Group · 1 Intervention: Healthy lifestyles education program · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HOLA Component 3
2019
N/A
~20
HOLA Component 4
2019
N/A
~20
HOLA Component 2
2019
N/A
~20
HOLA Component 1
2019
N/A
~20

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

National Institute on Minority Health and Health Disparities (NIMHD)NIH
280 Previous Clinical Trials
702,044 Total Patients Enrolled
20 Trials studying Depression
7,410 Patients Enrolled for Depression
University of MiamiLead Sponsor
787 Previous Clinical Trials
384,031 Total Patients Enrolled
25 Trials studying Depression
9,649 Patients Enrolled for Depression
Daniel E. Jimenez, Ph.D.Principal InvestigatorUniversity of Miami

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
A person is considered to have subthreshold depression if they score 5 or more points on the Patient Health Questionnaire (PHQ-9), OR a person is considered to have subthreshold anxiety if they score 5 or more points on the GAD-7.
If you want to take part in a health promotion intervention, you will need to get clearance from a doctor, physician's assistant, or nurse practitioner.
Do not meet the criteria for major depressive disorder or generalized anxiety disorder as indicated by the Mini International Neuropsychiatric Inventory (MINI).
The participant or participant's legally designated guardian or conservator has to voluntarily agree to participate in the study.
Not taking aspirin, ibuprofen (Advil, Motrin), or naproxen (Aleve) for 2 weeks before and 2 weeks after the first dose of study medication.
I expect to live in Miami for the next two years.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: November 14th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Florida100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Miami100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%