Exercise to Prevent Depression and Anxiety in Older Hispanics

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

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Behavioral: Happy Older Latinos are Active; Other: Fotonovela

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Jackson Memorial Mental Health Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	change from baseline at 16 months
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	change from baseline at 16 months
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.	change from baseline at 16 months
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 from baseline at 16 months
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 from baseline at 16 months
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	change from baseline at 16 months

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Daniel E Jimenez, Ph.D., University of Miami

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: January 21, 2015
• First Submitted That Met QC Criteria: February 20, 2015
• First Posted (Estimate): February 26, 2015

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 6, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: 20140607