Clinical trial NCT02371954: Exercise to Prevent Depression and Anxiety in Older Hispanics
Official title: Exercise to Prevent Depression and Anxiety in Older Hispanics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility 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.

Primary outcomes:
measure: Prevention of major depression, generalized anxiety, and social anxiety as measured the Mini International Neuropsychiatric Interview
timeFrame: change from baseline at 16 months
Secondary outcomes:
measure: Physical functioning as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2)
timeFrame: change from baseline at 16 months
measure: Social functioningas measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2)
timeFrame: change from baseline at 16 months
measure: Self-efficacy as measured by the General Self-Efficacy Scale
timeFrame: change from baseline at 16 months
measure: Sleep quality as measured by the Pittsburgh Sleep Quality Index
timeFrame: change from baseline at 16 months
measure: Change in depression symptom severity as measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR).
timeFrame: change from baseline at 16 months
measure: Change in anxiety symptom severity as measured by the Beck Anxiety Inventory (BAI)
timeFrame: change from baseline at 16 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Mental Health Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Daniel E Jimenez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.