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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD012610 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HOLA: A Culturally-Tailored Health Promotion Intervention | Experimental | 16 week, multicomponent, health promotion intervention |
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| Healthy lifestyles education program | Active Comparator | Educational material on mental health, physical activity, and information on community resources |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HOLA Component 1 | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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. | 2 years |
| Recurrence of generalized anxiety disorder | As measured by the SCID-5, a structured clinical interview used for diagnosis. | 2 years |
| Incidence of major depression disorder | As measured by the SCID-5, a structured clinical interview used for diagnosis. | 2 years |
| Recurrence of major depression disorder | As measured by the SCID-5, a structured clinical interview used for diagnosis. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pro-inflammatory markers | Obtained from plasma samples | Baseline, 16 weeks, 12, and 24 months |
| Change in anti-inflammatory markers | Obtained from plasma samples |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel E. Jimenez, Ph.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| HOLA Component 2 | Behavioral | 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. |
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| HOLA Component 3 | Behavioral | 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. |
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| HOLA Component 4 | Behavioral | One booster walking session twice a month for six months post intervention for reinforcement, then one booster walking session a month for eighteen months. |
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| Healthy lifestyles education program | Behavioral | Biweekly telephone check in calls for the first 16 weeks followed by monthly check in calls during the two year follow up period. |
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| 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. | 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. | Baseline, 16 weeks, 6, 12, 18, and 24 months |