Exercise to Prevent Depression and Anxiety in Older Hispanics

NCT02371954 | Completed

• 1 other identifier: 20140607
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  change from baseline at 16 months

Secondary Outcomes (6)

• Physical functioning as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2)

  change from baseline at 16 months

• Social functioningas measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2)

  change from baseline at 16 months

• Self-efficacy as measured by the General Self-Efficacy Scale

  change from baseline at 16 months

• Sleep quality as measured by the Pittsburgh Sleep Quality Index

  change from baseline at 16 months

• Change in depression symptom severity as measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR).

  change from baseline at 16 months

Study Arms (2)

Health Promotion

EXPERIMENTAL

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

Psychoeducation

ACTIVE COMPARATOR

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

Interventions

Happy Older Latinos are Active BEHAVIORAL

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

Also known as: HOLA

Health Promotion

Fotonovela OTHER

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

Psychoeducation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Jackson Memorial Mental Health Hospital

Miami, Florida, 33136, United States

Location

Related Publications (2)

• 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.

  PMID: 39621372 DERIVED

• 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.

  PMID: 26683695 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Daniel E Jimenez, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: February 26, 2015
• Study Start: September 1, 2013
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

US (1)