University of Miami
Miami, Florida, 33136, United States
NCT Number: NCT03870360
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.
This study is active but is not currently recruiting participants.
Notify Me60 year and older
All sexes
Interventional
Not applicable
Miami, Florida, 33136, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
One booster walking session twice a month for six months post intervention for reinforcement, then one booster walking session a month for eighteen months.
Biweekly telephone check in calls for the first 16 weeks followed by monthly check in calls during the two year follow up period.
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.
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
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.
Time frame: 2 years
As measured by the SCID-5, a structured clinical interview used for diagnosis.
Time frame: 2 years
As measured by the SCID-5, a structured clinical interview used for diagnosis.
Time frame: 2 years
As measured by the SCID-5, a structured clinical interview used for diagnosis.
Time frame: Baseline, 16 weeks, 12, and 24 months
Obtained from plasma samples
Time frame: Baseline, 16 weeks, 12, and 24 months
Obtained from plasma samples
Time frame: Baseline, 16 weeks, 6, 12, 18, and 24 months
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.
Time frame: Baseline, 16 weeks, 6, 12, 18, and 24 months
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.
University of Miami
Other
Health Promotion in the Prevention of Anxiety and Depression: the Happy Older Latinos Are Active (HOLA Study)
Acronym: HOLAA&D
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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