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Healthy Lifestyles Education for Preventing Anxiety and Depression (HOLAA&D Trial)
N/A
Recruiting
Led By Daniel E. Jimenez, Ph.D.
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 60+
Not taking steroidal or anti-inflammatory medication (including NSAIDs) within 2 weeks of treatment randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
HOLAA&D Trial Summary
This trial will compare two different approaches for preventing anxiety and depression in older Latinos at risk for developing these conditions.
Who is the study for?
This trial is for Latino adults aged 60 or older who may be at risk of anxiety and depression but do not currently have major depressive disorder (MDD) or generalized anxiety disorder (GAD). They should score ≥5 on specific questionnaires indicating some symptoms, not take certain anti-inflammatory medications, and must be medically cleared for physical activity.Check my eligibility
What is being tested?
The study is testing the effectiveness of a health promotion intervention against a healthy lifestyles education program in preventing anxiety and depression. Older Latinos will be randomly assigned to one of these two approaches to see which is more effective.See study design
What are the potential side effects?
Since the interventions involve lifestyle education and health promotion activities, significant side effects are not expected. However, participants might experience discomfort from new physical activities or changes in diet if included in the programs.
HOLAA&D Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 60 years old or older.
Select...
I haven't taken steroids or anti-inflammatory drugs in the last 2 weeks.
Select...
I am 60 years old or older.
HOLAA&D Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in risk factors for generalized anxiety disorder (GAD)
Change in risk factors for major depressive disorder (MDD)
Incidence of generalized anxiety disorder
+3 moreSecondary outcome measures
Change in anti-inflammatory markers
Change in physical functioning as measured by the physical performance battery
Change in pro-inflammatory markers
+1 moreHOLAA&D Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: HOLA: A Culturally-Tailored Health Promotion InterventionExperimental Treatment4 Interventions
16 week, multicomponent, health promotion intervention
Group II: Healthy lifestyles education programActive Control1 Intervention
Educational material on mental health, physical activity, and information on community resources
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HOLA Component 1
2019
N/A
~20
HOLA Component 2
2019
N/A
~20
HOLA Component 3
2019
N/A
~20
HOLA Component 4
2019
N/A
~20
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Who is running the clinical trial?
University of MiamiLead Sponsor
900 Previous Clinical Trials
409,692 Total Patients Enrolled
29 Trials studying Depression
10,022 Patients Enrolled for Depression
National Institute on Minority Health and Health Disparities (NIMHD)NIH
383 Previous Clinical Trials
1,215,971 Total Patients Enrolled
23 Trials studying Depression
7,615 Patients Enrolled for Depression
Daniel E. Jimenez, Ph.D.Principal InvestigatorUniversity of Miami
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You identify yourself as Latino.I am 60 years old or older.I have been diagnosed with bipolar, psychosis, or major depression with psychosis.I cannot walk 10 meters without assistance.You have struggled with alcohol or drug addiction in the past year.I currently smoke tobacco.I do not have any current infections.You have a serious illness that doctors expect will cause death within a year.You have mild symptoms of depression or anxiety, as indicated by a score of 5 or higher on certain questionnaires.I haven't taken steroids or anti-inflammatory drugs in the last 2 weeks.I have been diagnosed with a neurodegenerative disorder or dementia, or have significant cognitive impairment.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.I am currently on antidepressants or receiving mental health treatment.Do not meet the criteria for major depressive disorder or generalized anxiety disorder as indicated by the Mini International Neuropsychiatric Inventory (MINI).You have expressed thoughts or plans of hurting yourself or attempting suicide recently.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.I haven't taken any steroids or anti-inflammatory drugs in the last 2 weeks.You identify yourself as Latino.I have been diagnosed with major depression or anxiety in the last year.I am 60 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: HOLA: A Culturally-Tailored Health Promotion Intervention
- Group 2: Healthy lifestyles education program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the objectives of this investigation?
"This clinical trial will assess the impact of its intervention on major depressive disorder (MDD) risk factors over 6 time periods, namely Baseline, 16 weeks, 6 months, 12 months, 18 months and 24 months. The Short Form Health Survey 12v2 (SF-12v2), a measure of health related quality of life which yields two scores - Mental Component Summary Score (MCS) and Physical Component Summary Score (PCS), is used to determine any changes in patients' perceived quality of life. Pro-inflammatory markers and anti-inflammatory markers obtained from plasma samples are also monitored for potential changes due to the experimental treatment."
Answered by AI
Are there any unfilled vacancies in this clinical research project?
"Current information on clinicaltrials.gov affirms that this medical study is accepting applicants. The trial was formulated and last modified 11/1/2022, respectively."
Answered by AI
How many test subjects are involved in this experiment?
"Affirmative. According to the information available on clinicaltrials.gov, this research project which was first posted in November 1st 2022 is currently accepting applicants. A total of 240 individuals need to be recruited from a single medical facility for the trial's completion."
Answered by AI
Who else is applying?
What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
University of Miami
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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