DepressionHOLAA&DNCT03870360
Preventing Anxiety and Depression in Older Hispanics
A study testing HOLA Component 1, HOLA Component 2 and HOLA Component 3 in people with Depression and Anxiety, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- HOLA Component 1, HOLA Component 2 and HOLA Component 3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health Promotion in the Prevention of Anxiety and Depression: the Happy Older Latinos Are Active (HOLA Study)
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.
Read the 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
- Being tested
- HOLA Component 1, HOLA Component 2, HOLA Component 3, HOLA Component 4, Healthy lifestyles education program
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOLA Component 1Behavioural
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 2Behavioural
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 3Behavioural
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 4Behavioural
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 programBehavioural
Biweekly telephone check in calls for the first 16 weeks followed by monthly check in calls during the two year follow up period.
| Study group | Role | What they receive |
|---|---|---|
| HOLA: A Culturally-Tailored Health Promotion Intervention | Experimental | 16 week, multicomponent, health promotion intervention Receives: 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 Receives: Behavioral: Healthy lifestyles education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 2 years
Recurrence of generalized anxiety disorder
As measured by the SCID-5, a structured clinical interview used for diagnosis.
Measured: 2 years
Incidence of major depression disorder
As measured by the SCID-5, a structured clinical interview used for diagnosis.
Measured: 2 years
Recurrence of major depression disorder
As measured by the SCID-5, a structured clinical interview used for diagnosis.
Measured: 2 years
Secondary outcomes (4)
Change in pro-inflammatory markers
Obtained from plasma samples
Measured: Baseline, 16 weeks, 12, and 24 months
Change in anti-inflammatory markers
Obtained from plasma samples
Measured: Baseline, 16 weeks, 12, and 24 months
Change in physical functioning as measured by the physical performance battery
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.
Measured: Baseline, 16 weeks, 6, 12, 18, and 24 months
Change in quality of life
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.
Measured: Baseline, 16 weeks, 6, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Nov 2022
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Daniel Enrique Jimenez, University of Miami
- Investigators
- Daniel E. Jimenez, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870360
- Sponsor's protocol ID
- 20180816
- Other IDs
- R01MD012610
- Acronym
- HOLAA&D
- Status last verified
- Oct 2026
- First submitted
- 8 Mar 2019
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Promotion in the Prevention of Anxiety and Depression: the Happy Older Latinos Are Active (HOLA Study)
- ClinicalTrials.gov ID
- NCT03870360
- Acronym / sponsor ID
- HOLAA&D / 20180816
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOLA: A Culturally-Tailored Health Promotion Intervention | Experimental | Behavioral: HOLA Component 1, Behavioral: HOLA Component 2, Behavioral: HOLA Component 3, Behavioral: HOLA Component 416 week, multicomponent, health promotion intervention |
| Healthy lifestyles education program | Active comparator | Behavioral: Healthy lifestyles education programEducational material on mental health, physical activity, and information on community resources |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HOLA Component 1At 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. | Behavioural | HOLA: A Culturally-Tailored Health Promotion Intervention |
| HOLA Component 2A 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. | Behavioural | HOLA: A Culturally-Tailored Health Promotion Intervention |
| HOLA Component 3A 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. | Behavioural | HOLA: A Culturally-Tailored Health Promotion Intervention |
| HOLA Component 4One booster walking session twice a month for six months post intervention for reinforcement, then one booster walking session a month for eighteen months. | Behavioural | HOLA: A Culturally-Tailored Health Promotion Intervention |
| Healthy lifestyles education programBiweekly telephone check in calls for the first 16 weeks followed by monthly check in calls during the two year follow up period. | Behavioural | Healthy lifestyles education program |
Primary outcome
Change in risk factors for major depressive disorder (MDD)
Time frame: 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)
Time frame: 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 generalized anxiety disorder
Time frame: 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 generalized anxiety disorder
Time frame: 2 years
As measured by the SCID-5, a structured clinical interview used for diagnosis.
Incidence of major depression disorder
Time frame: 2 years
As measured by the SCID-5, a structured clinical interview used for diagnosis.
Recurrence of major depression disorder
Time frame: 2 years
As measured by the SCID-5, a structured clinical interview used for diagnosis.
4 secondary outcomes
Change in pro-inflammatory markers
Time frame: Baseline, 16 weeks, 12, and 24 months
Change in anti-inflammatory markers
Time frame: Baseline, 16 weeks, 12, and 24 months
Change in physical functioning as measured by the physical performance battery
Time frame: Baseline, 16 weeks, 6, 12, 18, and 24 months
Change in quality of life
Time frame: Baseline, 16 weeks, 6, 12, 18, and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel E. Jimenez, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOLA Component 1, HOLA Component 2 and HOLA Component 3 in people with Depression and Anxiety, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in risk factors for major depressive disorder (MDD) (time frame: Baseline, 16 weeks, 6, 12, 18, and 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.