Exercise to Prevent Depression and Anxiety in Older Hispanics

NCT ID: NCT02371954

Last Updated: 2018-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2018-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Happy Older Latinos are Active

Intervention Type BEHAVIORAL

Health promotion intervention desgined to prevent anxiety and depression in at risk older Hispanics

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.

Group Type ACTIVE_COMPARATOR

Fotonovela

Intervention Type OTHER

Comic book style informational booklet designed for people with low literacy to educate them on mental illness.

Interventions

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Happy Older Latinos are Active

Health promotion intervention desgined to prevent anxiety and depression in at risk older Hispanics

Intervention Type BEHAVIORAL

Fotonovela

Comic book style informational booklet designed for people with low literacy to educate them on mental illness.

Intervention Type OTHER

Other Intervention Names

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HOLA

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Daniel Enrique Jimenez

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel E Jimenez, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Jackson Memorial Mental Health Hospital

Miami, Florida, United States

Site Status

Countries

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United States

References

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Jimenez DE, Ross EJ, Weinstein ER, Martinez Garza D, Signorile JF, Perdomo-Johnson D, Martinez C. "Caminando y socializando con Happy Older Latinos are Active (HOLA)": Results of a randomized clinical trial to promote health and prevent depression and anxiety in older Latinos. J Consult Clin Psychol. 2025 Apr;93(4):317-327. doi: 10.1037/ccp0000923. Epub 2024 Dec 2.

Reference Type DERIVED
PMID: 39621372 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26683695 (View on PubMed)

Other Identifiers

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20140607

Identifier Type: -

Identifier Source: org_study_id

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