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The study is a randomized pilot trial of a health promotion intervention in the prevention of anxiety and depression in older Hispanics.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Happy Older Latinos are Active | Behavioral | Health promotion intervention desgined to prevent anxiety and depression in at risk older Hispanics |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | change from baseline at 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | change from baseline at 16 months |
| Social functioningas measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2) |
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Inclusion Criteria:
Exclusion Criteria:
(i) acute or severe medical illness that would prevent participants from walking at a moderate pace for 45 minutes, three times a week.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel E Jimenez, Ph.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jackson Memorial Mental Health Hospital | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39621372 | Derived | 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. | |
| 26683695 |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Fotonovela | Other | Comic book style informational booklet designed for people with low literacy to educate them on mental illness. |
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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 |
| 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. | 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 | 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 | 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 | change from baseline at 16 months |
| Jimenez 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. |