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Exercise to Prevent Depression and Anxiety in Older Hispanics

Primary Purpose

Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Happy Older Latinos are Active
Fotonovela
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Hispanic (self-identified);
  2. Age 60+;
  3. Minor depression as defined by a primary DSM-IV Axis I diagnosis of minor depressive disorder or subthreshold depression defined as a score ≥ 3 on the Patient Health Questionnaire (PHQ-2), OR subthreshold anxiety as defined as a score ≥ 3 on the Generalized Anxiety Disorder-2 scale (GAD-2);
  4. Absence of episodes of major depression and anxiety disorders for past 12 months (as determined by the MINI);
  5. Voluntary informed consent for participation in the study by the participant or by the participant's legally designated guardian or conservator;
  6. Medical clearance for participation in an exercise program by a physician, physician's assistant, or nurse practitioner;
  7. Expect to be resident in Miami for the subsequent 12 months.

Exclusion Criteria:

  1. Currently residing in a nursing or group home;
  2. A terminal physical illness expected to result in the death within one year;
  3. A diagnosis of dementia, co-morbid diagnosis of dementia, or significant cognitive impairment as indicated by an MMSE score <24;
  4. Presence of any axis 1 psychiatric disorder or substance abuse during preceding 12 months;
  5. History of psychiatric disorders other than non-psychotic unipolar major depression or anxiety disorder;
  6. 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);
  7. Participants taking cognitive enhancing medication or psychotropic medications (e.g. antidepressants);
  8. unable to complete 400 m walk test in less than 15 min;
  9. if participant heart rate exceeded 170 beats per minute OR systolic blood pressure exceeds 180 during 400 m walk test;
  10. chest or leg pain, dyspnea, dizziness, feeling faint, or other significant symptoms while completing 400 m walk test;

(i) acute or severe medical illness that would prevent participants from walking at a moderate pace for 45 minutes, three times a week.

Sites / Locations

  • Jackson Memorial Mental Health Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Health Promotion

Psychoeducation

Arm Description

Happy Older Latinos are Active (HOLA) is multicomponent health promotion intervention led by a community health worker (CHW). First component is a social and physical activation session. Participants meet individually with CHW for 30 minutes once at week 1, then again at week 8 (the midway point). Second component is a moderate intensity group walk. Groups will consist of 6 participants and will meet for one hour, 3 times a week, for 16 weeks. Third component is pleasant events scheduling during cool down phase of the group walk.

Participants will be given a fotonovela and will meet once a month after they receive the fotonovela to discuss their thoughts on the materials they received. These discussion groups will last one hour and will consist of 10 participants.

Outcomes

Primary Outcome Measures

Prevention of major depression, generalized anxiety, and social anxiety as measured the Mini International Neuropsychiatric Interview
I will be using the Mini International Neuropsychiatric Interview to test whether the HOLA intervention was successful in preventing participants from getting major depressive disorder, generalized anxiety disorder, and social anxiety disorder.

Secondary Outcome Measures

Physical functioning as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2)
I will be measuring the effect the HOLA intervention has on the scores of the Getting Around, Life Activities, and Self-Care subscales of the WHO-DAS 2.0
Social functioningas measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2)
I will be measuring the effect the HOLA intervention has on the scores of the Getting Along with People and Participation in Life subscales of the WHO-DAS 2.0
Self-efficacy as measured by the General Self-Efficacy Scale
I will be measuring the effect the HOLA intervention has on total scores of the General-Self Efficacy Scale.
Sleep quality as measured by the Pittsburgh Sleep Quality Index
I will be measuring the effect the HOLA intervention has on the total scores of the Pittsburgh Sleep Quality Index
Change in depression symptom severity as measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR).
I will be measuring the effect the HOLA intervention has on the total scores of the QIDS-SR
Change in anxiety symptom severity as measured by the Beck Anxiety Inventory (BAI)
I will be measuring the effect the HOLA intervention has on the total scores of the BAI

Full Information

First Posted
January 21, 2015
Last Updated
September 6, 2018
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT02371954
Brief Title
Exercise to Prevent Depression and Anxiety in Older Hispanics
Official Title
Exercise to Prevent Depression and Anxiety in Older Hispanics
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

5. Study Description

Brief Summary
The study is a randomized pilot trial of a health promotion intervention in the prevention of anxiety and depression in older Hispanics.
Detailed Description
Eligible participants will be randomized to either the Happy Older Latinos are Active (HOLA) intervention or a psychoeducation condition. Participants randomized to HOLA will participate in a group exercise, 3 times a week, for 16 weeks. The exercise is a moderate intensity walk at a centrally located park in Miami-Dade county and will last for an hour (10 minute warmup/stretching, 30 minute walk, 5 minute cool down). Groups will consist of 6 participants and be led by a community health worker. During the cool down phase, participants will plan a pleasant event to be done in between sessions. Participants randomized to the psychoeducation component will receive a fotonovela and will meet once a month after they receive the fotonovela to discuss their thoughts on the materials they received. These discussion groups will last one hour and will consist of 10 participants. A total of 60 participants will be randomized (30 to HOLA, 30 to fotonovela). Assessments will be conducted at baseline, post intervention, 6 months post-intervention, and 12 months post-intervention.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Health Promotion
Arm Type
Experimental
Arm Description
Happy Older Latinos are Active (HOLA) is multicomponent health promotion intervention led by a community health worker (CHW). First component is a social and physical activation session. Participants meet individually with CHW for 30 minutes once at week 1, then again at week 8 (the midway point). Second component is a moderate intensity group walk. Groups will consist of 6 participants and will meet for one hour, 3 times a week, for 16 weeks. Third component is pleasant events scheduling during cool down phase of the group walk.
Arm Title
Psychoeducation
Arm Type
Active Comparator
Arm Description
Participants will be given a fotonovela and will meet once a month after they receive the fotonovela to discuss their thoughts on the materials they received. These discussion groups will last one hour and will consist of 10 participants.
Intervention Type
Behavioral
Intervention Name(s)
Happy Older Latinos are Active
Other Intervention Name(s)
HOLA
Intervention Description
Health promotion intervention desgined to prevent anxiety and depression in at risk older Hispanics
Intervention Type
Other
Intervention Name(s)
Fotonovela
Intervention Description
Comic book style informational booklet designed for people with low literacy to educate them on mental illness.
Primary Outcome Measure Information:
Title
Prevention of major depression, generalized anxiety, and social anxiety as measured the Mini International Neuropsychiatric Interview
Description
I will be using the Mini International Neuropsychiatric Interview to test whether the HOLA intervention was successful in preventing participants from getting major depressive disorder, generalized anxiety disorder, and social anxiety disorder.
Time Frame
change from baseline at 16 months
Secondary Outcome Measure Information:
Title
Physical functioning as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2)
Description
I will be measuring the effect the HOLA intervention has on the scores of the Getting Around, Life Activities, and Self-Care subscales of the WHO-DAS 2.0
Time Frame
change from baseline at 16 months
Title
Social functioningas measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2)
Description
I will be measuring the effect the HOLA intervention has on the scores of the Getting Along with People and Participation in Life subscales of the WHO-DAS 2.0
Time Frame
change from baseline at 16 months
Title
Self-efficacy as measured by the General Self-Efficacy Scale
Description
I will be measuring the effect the HOLA intervention has on total scores of the General-Self Efficacy Scale.
Time Frame
change from baseline at 16 months
Title
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Description
I will be measuring the effect the HOLA intervention has on the total scores of the Pittsburgh Sleep Quality Index
Time Frame
change from baseline at 16 months
Title
Change in depression symptom severity as measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR).
Description
I will be measuring the effect the HOLA intervention has on the total scores of the QIDS-SR
Time Frame
change from baseline at 16 months
Title
Change in anxiety symptom severity as measured by the Beck Anxiety Inventory (BAI)
Description
I will be measuring the effect the HOLA intervention has on the total scores of the BAI
Time Frame
change from baseline at 16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Hispanic (self-identified); Age 60+; Minor depression as defined by a primary DSM-IV Axis I diagnosis of minor depressive disorder or subthreshold depression defined as a score ≥ 3 on the Patient Health Questionnaire (PHQ-2), OR subthreshold anxiety as defined as a score ≥ 3 on the Generalized Anxiety Disorder-2 scale (GAD-2); Absence of episodes of major depression and anxiety disorders for past 12 months (as determined by the 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 an exercise program by a physician, physician's assistant, or nurse practitioner; Expect to be resident in Miami for the subsequent 12 months. Exclusion Criteria: Currently residing in a nursing or group home; A terminal physical illness expected to result in the death within one year; A diagnosis of dementia, co-morbid diagnosis of dementia, or significant cognitive impairment as indicated by an MMSE score <24; Presence of any axis 1 psychiatric disorder or substance abuse during preceding 12 months; History of psychiatric disorders other than non-psychotic unipolar major depression or anxiety disorder; 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); Participants taking cognitive enhancing medication or psychotropic medications (e.g. antidepressants); unable to complete 400 m walk test in less than 15 min; if participant heart rate exceeded 170 beats per minute OR systolic blood pressure exceeds 180 during 400 m walk test; chest or leg pain, dyspnea, dizziness, feeling faint, or other significant symptoms while completing 400 m walk test; (i) acute or severe medical illness that would prevent participants from walking at a moderate pace for 45 minutes, three times a week.
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
Jackson Memorial Mental Health Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26683695
Citation
Jimenez DE, Reynolds CF 3rd, Alegria M, Harvey P, Bartels SJ. The Happy Older Latinos are Active (HOLA) health promotion and prevention study: study protocol for a pilot randomized controlled trial. Trials. 2015 Dec 18;16:579. doi: 10.1186/s13063-015-1113-3.
Results Reference
derived

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Exercise to Prevent Depression and Anxiety in Older Hispanics

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