Preventing Anxiety and Depression in Older Hispanics

Depression Clinical Trial

— HOLAA&D  

Official title:

Health Promotion in the Prevention of Anxiety and Depression: the Happy Older Latinos Are Active (HOLA Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03870360
• Other study ID #: 20180816
• Secondary ID: R01MD012610
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: October 2023
• Source: University of Miami
• Contact: Daniel E. Jimenez, Ph.D.
• Phone: 305-355-9063
• Email: dej18[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• 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).

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

Behavioral:
• HOLA Component 1
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 2
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 3
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 4
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 program
Biweekly telephone check in calls for the first 16 weeks followed by monthly check in calls during the two year follow up period.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Recurrence of generalized anxiety disorder	As measured by the SCID-5, a structured clinical interview used for diagnosis.	2 years
Primary	Incidence of major depression disorder	As measured by the SCID-5, a structured clinical interview used for diagnosis.	2 years
Primary	Recurrence of major depression disorder	As measured by the SCID-5, a structured clinical interview used for diagnosis.	2 years
Secondary	Change in pro-inflammatory markers	Obtained from plasma samples	Baseline, 16 weeks, 12, and 24 months
Secondary	Change in anti-inflammatory markers	Obtained from plasma samples	Baseline, 16 weeks, 12, and 24 months
Secondary	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
Secondary	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