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Exercise to Prevent Depression and Anxiety in Older Hispanics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02371954
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel Enrique Jimenez, University of Miami

Brief Summary:
The study is a randomized pilot trial of a health promotion intervention in the prevention of anxiety and depression in older Hispanics.

Condition or disease Intervention/treatment Phase
Anxiety Depression Behavioral: Happy Older Latinos are Active Other: Fotonovela Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Exercise to Prevent Depression and Anxiety in Older Hispanics
Actual Study Start Date : September 2013
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Health Promotion
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.
Behavioral: Happy Older Latinos are Active
Health promotion intervention desgined to prevent anxiety and depression in at risk older Hispanics
Other Name: HOLA

Active Comparator: Psychoeducation
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.
Other: Fotonovela
Comic book style informational booklet designed for people with low literacy to educate them on mental illness.




Primary Outcome Measures :
  1. Prevention of major depression, generalized anxiety, and social anxiety as measured the Mini International Neuropsychiatric Interview [ Time Frame: change from baseline at 16 months ]
    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 :
  1. Physical functioning as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2) [ Time Frame: change from baseline at 16 months ]
    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

  2. Social functioningas measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2) [ Time Frame: change from baseline at 16 months ]
    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

  3. Self-efficacy as measured by the General Self-Efficacy Scale [ Time Frame: change from baseline at 16 months ]
    I will be measuring the effect the HOLA intervention has on total scores of the General-Self Efficacy Scale.

  4. Sleep quality as measured by the Pittsburgh Sleep Quality Index [ Time Frame: change from baseline at 16 months ]
    I will be measuring the effect the HOLA intervention has on the total scores of the Pittsburgh Sleep Quality Index

  5. Change in depression symptom severity as measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR). [ Time Frame: change from baseline at 16 months ]
    I will be measuring the effect the HOLA intervention has on the total scores of the QIDS-SR

  6. Change in anxiety symptom severity as measured by the Beck Anxiety Inventory (BAI) [ Time Frame: change from baseline at 16 months ]
    I will be measuring the effect the HOLA intervention has on the total scores of the BAI



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371954


Locations
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United States, Florida
Jackson Memorial Mental Health Hospital
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Daniel E Jimenez, Ph.D. University of Miami
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniel Enrique Jimenez, Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02371954    
Other Study ID Numbers: 20140607
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders