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Preventing Anxiety and Depression in Older Hispanics

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ClinicalTrials.gov Identifier: NCT03870360
Recruitment Status : Not yet recruiting
First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Daniel Enrique Jimenez, University of Miami

Tracking Information
First Submitted Date  ICMJE March 8, 2019
First Posted Date  ICMJE March 12, 2019
Last Update Posted Date March 12, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date December 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
  • Change in risk factors for major depressive disorder (MDD) [ 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.
  • Change in risk factors for generalized anxiety disorder (GAD) [ 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
  • Incidence of generalized anxiety disorder [ Time Frame: 2 years ]
    As measured by the Mini International Neuropsychiatric Inventory, a structured clinical interview used for diagnosis.
  • Recurrence of generalized anxiety disorder [ Time Frame: 2 years ]
    As measured by the Mini International Neuropsychiatric Inventory, a structured clinical interview used for diagnosis.
  • Incidence of major depression disorder [ Time Frame: 2 years ]
    As measured by the Mini International Neuropsychiatric Inventory, a structured clinical interview used for diagnosis.
  • Recurrence of major depression disorder [ Time Frame: 2 years ]
    As measured by the Mini International Neuropsychiatric Inventory, a structured clinical interview used for diagnosis.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
  • Change in pro-inflammatory markers [ Time Frame: Baseline, 16 weeks, 12, and 24 months ]
    Obtained from plasma samples
  • Change in anti-inflammatory markers [ Time Frame: Baseline, 16 weeks, 12, and 24 months ]
    Obtained from plasma samples
  • Change in physical functioning as measured by the physical performance battery [ 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.
  • Change in quality of life [ 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventing Anxiety and Depression in Older Hispanics
Official Title  ICMJE Health Promotion in the Prevention of Anxiety and Depression: the Happy Older Latinos Are Active (HOLA Study)
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Depression
  • Anxiety
Intervention  ICMJE
  • 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.
  • Behavioral: 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.
  • Behavioral: 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.
  • Behavioral: 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.
  • Behavioral: 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.
Study Arms  ICMJE
  • Experimental: HOLA
    16 week, multicomponent, health promotion intervention
    Interventions:
    • Behavioral: HOLA Component 1
    • Behavioral: HOLA Component 2
    • Behavioral: HOLA Component 3
    • Behavioral: HOLA Component 4
  • Active Comparator: Healthy lifestyles education program
    Educational material on mental health, physical activity, and information on community resources
    Intervention: Behavioral: Healthy lifestyles education program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 8, 2019)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2025
Estimated Primary Completion Date December 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Daniel E. Jimenez, Ph.D. 305-355-9063 dej18@miami.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03870360
Other Study ID Numbers  ICMJE 20180816
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Daniel Enrique Jimenez, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE National Institute on Minority Health and Health Disparities (NIMHD)
Investigators  ICMJE
Principal Investigator: Daniel E. Jimenez, Ph.D. University of Miami
PRS Account University of Miami
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP