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Preventing Anxiety and Depression in Older Hispanics (HOLAA&D)

Primary Purpose

Depression, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HOLA Component 1
HOLA Component 2
HOLA Component 3
HOLA Component 4
Healthy lifestyles education program
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HOLA: A Culturally-Tailored Health Promotion Intervention

Healthy lifestyles education program

Arm Description

16 week, multicomponent, health promotion intervention

Educational material on mental health, physical activity, and information on community resources

Outcomes

Primary Outcome Measures

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.
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
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.
Recurrence of generalized anxiety disorder
As measured by the SCID-5, a structured clinical interview used for diagnosis.
Incidence of major depression disorder
As measured by the SCID-5, a structured clinical interview used for diagnosis.
Recurrence of major depression disorder
As measured by the SCID-5, a structured clinical interview used for diagnosis.

Secondary Outcome Measures

Change in pro-inflammatory markers
Obtained from plasma samples
Change in anti-inflammatory markers
Obtained from plasma samples
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.
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.

Full Information

First Posted
March 8, 2019
Last Updated
April 24, 2023
Sponsor
University of Miami
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03870360
Brief Title
Preventing Anxiety and Depression in Older Hispanics
Acronym
HOLAA&D
Official Title
Health Promotion in the Prevention of Anxiety and Depression: the Happy Older Latinos Are Active (HOLA Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HOLA: A Culturally-Tailored Health Promotion Intervention
Arm Type
Experimental
Arm Description
16 week, multicomponent, health promotion intervention
Arm Title
Healthy lifestyles education program
Arm Type
Active Comparator
Arm Description
Educational material on mental health, physical activity, and information on community resources
Intervention Type
Behavioral
Intervention Name(s)
HOLA Component 1
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HOLA Component 2
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HOLA Component 3
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HOLA Component 4
Intervention Description
One booster walking session twice a month for six months post intervention for reinforcement, then one booster walking session a month for eighteen months.
Intervention Type
Behavioral
Intervention Name(s)
Healthy lifestyles education program
Intervention Description
Biweekly telephone check in calls for the first 16 weeks followed by monthly check in calls during the two year follow up period.
Primary Outcome Measure Information:
Title
Change in risk factors for major depressive disorder (MDD)
Description
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
Title
Change in risk factors for generalized anxiety disorder (GAD)
Description
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
Baseline, 16 weeks, 6, 12, 18, and 24 months
Title
Incidence of generalized anxiety disorder
Description
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
Title
Recurrence of generalized anxiety disorder
Description
As measured by the SCID-5, a structured clinical interview used for diagnosis.
Time Frame
2 years
Title
Incidence of major depression disorder
Description
As measured by the SCID-5, a structured clinical interview used for diagnosis.
Time Frame
2 years
Title
Recurrence of major depression disorder
Description
As measured by the SCID-5, a structured clinical interview used for diagnosis.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Change in pro-inflammatory markers
Description
Obtained from plasma samples
Time Frame
Baseline, 16 weeks, 12, and 24 months
Title
Change in anti-inflammatory markers
Description
Obtained from plasma samples
Time Frame
Baseline, 16 weeks, 12, and 24 months
Title
Change in physical functioning as measured by the physical performance battery
Description
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
Title
Change in quality of life
Description
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.
Time Frame
Baseline, 16 weeks, 6, 12, 18, and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel E. Jimenez, Ph.D.
Phone
305-355-9063
Email
dej18@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel E. Jimenez, Ph.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel E. Jimenez, Ph.D.
Phone
305-355-9063
Email
dej18@miami.edu
First Name & Middle Initial & Last Name & Degree
Daniel E. Jimenez, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Preventing Anxiety and Depression in Older Hispanics

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