AnxietyNCT02371954
Exercise to Prevent Depression and Anxiety in Older Hispanics
A study testing Happy Older Latinos are Active and Fotonovela in people with Anxiety and Depression, run by University of Miami at 1 site in United States.
Trial summary
The study is a randomized pilot trial of a health promotion intervention in the prevention of anxiety and depression in older Hispanics. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Happy Older Latinos are Active and Fotonovela
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hispanic (self-identified);
- Age 60+;
- Minor depression as defined by a primary DSM-IV Axis I diagnosis of minor depressive disorder or subthreshold depression defined as a score ≥ 3 on the Patient Health Questionnaire (PHQ-2), OR subthreshold anxiety as defined as a score ≥ 3 on the Generalized Anxiety Disorder-2 scale (GAD-2);
- Absence of episodes of major depression and anxiety disorders for past 12 months (as determined by the 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 an exercise program by a physician, physician's assistant, or nurse practitioner;
- Expect to be resident in Miami for the subsequent 12 months.
Who cannot join
- Currently residing in a nursing or group home;
- A terminal physical illness expected to result in the death within one year;
- A diagnosis of dementia, co-morbid diagnosis of dementia, or significant cognitive impairment as indicated by an MMSE score <24;
- Presence of any axis 1 psychiatric disorder or substance abuse during preceding 12 months;
- History of psychiatric disorders other than non-psychotic unipolar major depression or anxiety disorder;
- 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);
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- Participants taking cognitive enhancing medication or psychotropic medications (e.g. antidepressants);
- unable to complete 400 m walk test in less than 15 min;
- if participant heart rate exceeded 170 beats per minute OR systolic blood pressure exceeds 180 during 400 m walk test;
- chest or leg pain, dyspnea, dizziness, feeling faint, or other significant symptoms while completing 400 m walk test;
- acute or severe medical illness that would prevent participants from walking at a moderate pace for 45 minutes, three times a week.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jackson Memorial Mental Health Hospital
Miami, Florida, 33136
About this study
The study is a randomized pilot trial of a health promotion intervention in the prevention of anxiety and depression in older Hispanics.
Read the detailed description
Eligible participants will be randomized to either the Happy Older Latinos are Active (HOLA) intervention or a psychoeducation condition. Participants randomized to HOLA will participate in a group exercise, 3 times a week, for 16 weeks. The exercise is a moderate intensity walk at a centrally located park in Miami-Dade county and will last for an hour (10 minute warmup/stretching, 30 minute walk, 5 minute cool down). Groups will consist of 6 participants and be led by a community health worker. During the cool down phase, participants will plan a pleasant event to be done in between sessions. Participants randomized to the psychoeducation component will receive a fotonovela and will meet once a month after they receive the fotonovela to discuss their thoughts on the materials they received. These discussion groups will last one hour and will consist of 10 participants. A total of 60 participants will be randomized (30 to HOLA, 30 to fotonovela). Assessments will be conducted at baseline, post intervention, 6 months post-intervention, and 12 months post-intervention.
- Conditions
- Anxiety, Depression
- Being tested
- Happy Older Latinos are Active, Fotonovela
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Happy Older Latinos are ActiveBehavioural
Also called HOLA
Health promotion intervention desgined to prevent anxiety and depression in at risk older Hispanics
FotonovelaOther
Comic book style informational booklet designed for people with low literacy to educate them on mental illness.
| Study group | Role | What they receive |
|---|---|---|
| Health Promotion | Experimental | Happy Older Latinos are Active (HOLA) is multicomponent health promotion intervention led by a community health worker (CHW). First component is a social and physical activation session. Participants meet individually with CHW for 30 minutes once at week 1, then again at week 8 (the midway point). Second component is a moderate intensity group walk. Groups will consist of 6 participants and will meet for one hour, 3 times a week, for 16 weeks. Third component is pleasant events scheduling during cool down phase of the group walk. Receives: Behavioral: Happy Older Latinos are Active |
| Psychoeducation | Active comparator | Participants will be given a fotonovela and will meet once a month after they receive the fotonovela to discuss their thoughts on the materials they received. These discussion groups will last one hour and will consist of 10 participants. Receives: Other: Fotonovela |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of major depression, generalized anxiety, and social anxiety as measured the Mini International Neuropsychiatric Interview
I will be using the Mini International Neuropsychiatric Interview to test whether the HOLA intervention was successful in preventing participants from getting major depressive disorder, generalized anxiety disorder, and social anxiety disorder.
Measured: change from baseline at 16 months
Secondary outcomes (6)
Physical functioning as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2)
I will be measuring the effect the HOLA intervention has on the scores of the Getting Around, Life Activities, and Self-Care subscales of the WHO-DAS 2.0
Measured: change from baseline at 16 months
Social functioningas measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2)
I will be measuring the effect the HOLA intervention has on the scores of the Getting Along with People and Participation in Life subscales of the WHO-DAS 2.0
Measured: change from baseline at 16 months
Self-efficacy as measured by the General Self-Efficacy Scale
I will be measuring the effect the HOLA intervention has on total scores of the General-Self Efficacy Scale.
Measured: change from baseline at 16 months
Sleep quality as measured by the Pittsburgh Sleep Quality Index
I will be measuring the effect the HOLA intervention has on the total scores of the Pittsburgh Sleep Quality Index
Measured: change from baseline at 16 months
Change in depression symptom severity as measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR).
I will be measuring the effect the HOLA intervention has on the total scores of the QIDS-SR
Measured: change from baseline at 16 months
Change in anxiety symptom severity as measured by the Beck Anxiety Inventory (BAI)
I will be measuring the effect the HOLA intervention has on the total scores of the BAI
Measured: change from baseline at 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startSep 2013
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- 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
- NCT02371954
- Sponsor's protocol ID
- 20140607
- Status last verified
- Sep 2018
- First submitted
- 21 Jan 2015
- Last updated
- 7 Sep 2018
- Results posted
- No
Publications
Jimenez DE, Ross EJ, Weinstein ER, Martinez Garza D, Signorile JF, Perdomo-Johnson D, Martinez C. "Caminando y socializando con Happy Older Latinos are Active (HOLA)": Results of a randomized clinical trial to promote health and prevent depression and anxiety in older Latinos. J Consult Clin Psychol. 2025 Apr;93(4):317-327. doi: 10.1037/ccp0000923. Epub 2024 Dec 2.
PubMed 39621372Jimenez DE, Reynolds CF 3rd, Alegria M, Harvey P, Bartels SJ. The Happy Older Latinos are Active (HOLA) health promotion and prevention study: study protocol for a pilot randomized controlled trial. Trials. 2015 Dec 18;16:579. doi: 10.1186/s13063-015-1113-3.
PubMed 26683695
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise to Prevent Depression and Anxiety in Older Hispanics
- ClinicalTrials.gov ID
- NCT02371954
- Acronym / sponsor ID
- 20140607
- Conditions
- Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 26 Feb 2015 (estimated)
- 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 study is a randomized pilot trial of a health promotion intervention in the prevention of anxiety and depression in older Hispanics.
Detailed description
Eligible participants will be randomized to either the Happy Older Latinos are Active (HOLA) intervention or a psychoeducation condition. Participants randomized to HOLA will participate in a group exercise, 3 times a week, for 16 weeks. The exercise is a moderate intensity walk at a centrally located park in Miami-Dade county and will last for an hour (10 minute warmup/stretching, 30 minute walk, 5 minute cool down). Groups will consist of 6 participants and be led by a community health worker. During the cool down phase, participants will plan a pleasant event to be done in between sessions. Participants randomized to the psychoeducation component will receive a fotonovela and will meet once a month after they receive the fotonovela to discuss their thoughts on the materials they received. These discussion groups will last one hour and will consist of 10 participants. A total of 60 participants will be randomized (30 to HOLA, 30 to fotonovela). Assessments will be conducted at baseline, post intervention, 6 months post-intervention, and 12 months post-intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Promotion | Experimental | Behavioral: Happy Older Latinos are ActiveHappy Older Latinos are Active (HOLA) is multicomponent health promotion intervention led by a community health worker (CHW). First component is a social and physical activation session. Participants meet individually with CHW for 30 minutes once at week 1, then again at week 8 (the midway point). Second component is a moderate intensity group walk. Groups will consist of 6 participants and will meet for one hour, 3 times a week, for 16 weeks. Third component is pleasant events scheduling during cool down phase of the group walk. |
| Psychoeducation | Active comparator | Other: FotonovelaParticipants will be given a fotonovela and will meet once a month after they receive the fotonovela to discuss their thoughts on the materials they received. These discussion groups will last one hour and will consist of 10 participants. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hispanic (self-identified);
- Age 60+;
- Minor depression as defined by a primary DSM-IV Axis I diagnosis of minor depressive disorder or subthreshold depression defined as a score ≥ 3 on the Patient Health Questionnaire (PHQ-2), OR subthreshold anxiety as defined as a score ≥ 3 on the Generalized Anxiety Disorder-2 scale (GAD-2);
- Absence of episodes of major depression and anxiety disorders for past 12 months (as determined by the 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 (11 listed)
- Currently residing in a nursing or group home;
- A terminal physical illness expected to result in the death within one year;
- A diagnosis of dementia, co-morbid diagnosis of dementia, or significant cognitive impairment as indicated by an MMSE score <24;
- Presence of any axis 1 psychiatric disorder or substance abuse during preceding 12 months;
- History of psychiatric disorders other than non-psychotic unipolar major depression or anxiety disorder;
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 |
|---|---|---|
| Happy Older Latinos are ActiveAlso: HOLAHealth promotion intervention desgined to prevent anxiety and depression in at risk older Hispanics | Behavioural | Health Promotion |
| FotonovelaComic book style informational booklet designed for people with low literacy to educate them on mental illness. | Other | Psychoeducation |
Primary outcome
Prevention of major depression, generalized anxiety, and social anxiety as measured the Mini International Neuropsychiatric Interview
Time frame: change from baseline at 16 months
I will be using the Mini International Neuropsychiatric Interview to test whether the HOLA intervention was successful in preventing participants from getting major depressive disorder, generalized anxiety disorder, and social anxiety disorder.
6 secondary outcomes
Physical functioning as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2)
Time frame: change from baseline at 16 months
Social functioningas measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2)
Time frame: change from baseline at 16 months
Self-efficacy as measured by the General Self-Efficacy Scale
Time frame: change from baseline at 16 months
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Time frame: change from baseline at 16 months
Change in depression symptom severity as measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR).
Time frame: change from baseline at 16 months
Change in anxiety symptom severity as measured by the Beck Anxiety Inventory (BAI)
Time frame: change from baseline at 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Derived from this study: PubMed 39621372Jimenez DE, Ross EJ, Weinstein ER, Martinez Garza D, Signorile JF, Perdomo-Johnson D, Martinez C. "Caminando y socializando con Happy Older Latinos are Active (HOLA)": Results of a randomized clinical trial to promote health and prevent depression and anxiety in older Latinos. J Consult Clin Psychol. 2025 Apr;93(4):317-327. doi: 10.1037/ccp0000923. Epub 2024 Dec 2.
- Derived from this study: PubMed 26683695Jimenez DE, Reynolds CF 3rd, Alegria M, Harvey P, Bartels SJ. The Happy Older Latinos are Active (HOLA) health promotion and prevention study: study protocol for a pilot randomized controlled trial. Trials. 2015 Dec 18;16:579. doi: 10.1186/s13063-015-1113-3.
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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 Happy Older Latinos are Active and Fotonovela in people with Anxiety and Depression, 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 7 Sep 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevention of major depression, generalized anxiety, and social anxiety as measured the Mini International Neuropsychiatric Interview (time frame: change from baseline at 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02371954, which also lists 2 linked publications.
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 7 Sep 2018.