Exercise to Prevent Depression and Anxiety in Older Hispanics

Depression Clinical Trial

Official title:

Exercise to Prevent Depression and Anxiety in Older Hispanics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371954
• Other study ID #: 20140607
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: August 2018

Study information

• Verified date: September 2018
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

Behavioral:
• Happy Older Latinos are Active
Health promotion intervention desgined to prevent anxiety and depression in at risk older Hispanics

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

Locations

Country	Name	City	State
United States	Jackson Memorial Mental Health Hospital	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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