Healthy Lifestyles Education for Preventing Anxiety and Depression

(HOLAA&D Trial)

Overseen By Daniel Jimenez, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Must not be taking: Steroids, Anti-inflammatories, Antidepressants, others

Disqualifiers: MDD, GAD, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best methods to prevent anxiety and depression in older Latino adults at risk. Participants will join one of two groups at random: a health promotion program or a healthy lifestyles education program. The trial seeks Latino individuals over 60 with mild symptoms of anxiety or depression but without a full diagnosis. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance mental health strategies for their community.

Will I have to stop taking my current medications?

The trial requires that you are not taking steroidal or anti-inflammatory medications (like NSAIDs) within 2 weeks of starting the study. Also, you cannot be currently receiving antidepressant medication or participating in other mental health treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the HOLA health program is safe for participants. It promotes exercise and social activities to help prevent depression and anxiety. Previous studies indicate that elderly Latino communities respond well to this approach, with participants typically not experiencing serious side effects.

The healthy lifestyles education program, which provides information on mental health and exercise, is also considered safe. This program aims to inform participants, and no evidence suggests harmful health effects from this type of program.

Overall, both programs in the trial are designed to be safe and beneficial for those seeking to prevent anxiety and depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Healthy Lifestyles Education for Preventing Anxiety and Depression trial because it offers a culturally-tailored approach to mental health education, unlike standard treatments like medication or therapy. The HOLA intervention is unique because it combines multiple components into a 16-week program specifically designed to be culturally relevant, which could enhance engagement and effectiveness for diverse populations. Additionally, this trial emphasizes education and community resource awareness, promoting sustainable lifestyle changes that might prevent anxiety and depression rather than just treating symptoms.

What evidence suggests that this trial's treatments could be effective for preventing anxiety and depression?

Research shows that the HOLA health promotion program, one of the interventions in this trial, can help prevent anxiety and depression in older Latino adults. Previous studies have found that this program, which includes physical activities and other health-promoting actions, is practical and well-liked by participants. These studies have also gathered information on its impact on depression and anxiety, showing promising results in reducing these conditions. In this trial, another group of participants will receive the healthy lifestyles education program, which offers educational materials on mental health and physical activity. However, less detailed information exists on its effectiveness in preventing anxiety and depression. Overall, both programs in this trial aim to support mental well-being through lifestyle changes. ^{1 2 4 6 7}

Who Is on the Research Team?

Daniel Jimenez, Ph.D.

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for Latino adults aged 60 or older who may be at risk of anxiety and depression but do not currently have major depressive disorder (MDD) or generalized anxiety disorder (GAD). They should score ≥5 on specific questionnaires indicating some symptoms, not take certain anti-inflammatory medications, and must be medically cleared for physical activity.

Inclusion Criteria

Do not meet criteria for current MDD or GAD as indicated by the Mini International Neuropsychiatric Inventory (MINI)

Medical clearance for participation in a health promotion intervention by a physician, physician's assistant, or nurse practitioner

I am 60 years old or older.

Exclusion Criteria

I have been diagnosed with bipolar, psychosis, or major depression with psychosis.

I cannot walk 10 meters without assistance.

You have struggled with alcohol or drug addiction in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either a health promotion intervention or a healthy lifestyles education program

16 weeks

Follow-up

Participants are monitored for changes in quality of life, physical functioning, and mental health outcomes

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Healthy lifestyles education program
• HOLA Component 1
• HOLA Component 2
• HOLA Component 3
• HOLA Component 4

Trial Overview The study is testing the effectiveness of a health promotion intervention against a healthy lifestyles education program in preventing anxiety and depression. Older Latinos will be randomly assigned to one of these two approaches to see which is more effective.

How Is the Trial Designed?

Group I: HOLA: A Culturally-Tailored Health Promotion Intervention Experimental Treatment 4 Interventions

16 week, multicomponent, health promotion intervention

Group II: Healthy lifestyles education program Active Control 1 Intervention

Educational material on mental health, physical activity, and information on community resources

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

A systematic review identified eight studies of internet-based programs for treating anxiety and depression in children and adolescents, with most interventions based on cognitive behavior therapy.

Six out of eight studies reported reductions in symptoms of anxiety and/or depression after the interventions, indicating early support for the effectiveness of these online programs, although more rigorous research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of internet-based prevention and treatment programs for anxiety and depression in children and adolescents. Calear, AL., Christensen, H.[2022]

The CATCH-IT online intervention effectively reduces depressive symptoms in adolescents, showing significant improvement over 24 months, similar to an online health education program.

Both CATCH-IT and health education led to significant reductions in depressive symptoms, but CATCH-IT also showed a notable effect on reducing anxiety, highlighting its potential for broader mental health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Clinical Trial of an Internet-Based Adolescent Depression Prevention Intervention in Primary Care: Internalizing Symptom Outcomes. Gladstone, T., Buchholz, KR., Fitzgibbon, M., et al.[2021]

Lifestyle interventions for individuals with serious mental illness can lead to significant improvements in weight loss and metabolic syndrome risk factors, as shown in 12 out of 23 reviewed studies.

There is a notable lack of representation of racial and ethnic minority groups in these studies, which limits the generalizability of the findings, particularly for Hispanics and Asian Americans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle interventions for adults with serious mental illness: a systematic literature review. Cabassa, LJ., Ezell, JM., Lewis-Fernández, R.[2021]

The Inner North Brisbane Mental Health Service implemented a structured Healthy Living Program with three modules focusing on Nutrition, Physical Health, and Community Activities, which received positive feedback from participants, indicating satisfaction and intention to adopt healthier lifestyle changes.

While the program has shown immediate positive responses from participants, further research is needed to assess the long-term impact of the program on health and well-being among mental health service recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing the health and lifestyle issues of people with a mental illness: the Healthy Living Programme. O'Sullivan, J., Gilbert, J., Ward, W.[2017]

In a study involving 14,591 health plan members over 6 years, lifestyle health coaching programs led to significant improvements, with 44.2% of participants losing 5% or more of their baseline weight and 50.5% meeting physical activity guidelines after 180 days.

The programs also showed positive outcomes in stress reduction (77% reported reduced stress), nutrition improvement (65.2%), and tobacco cessation (7% quit), highlighting the effectiveness of evidence-based coaching in promoting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evaluation of Lifestyle Health Coaching Programs Using Trained Health Coaches and Evidence-Based Curricula at 6 Months Over 6 Years. Budzowski, AR., Parkinson, MD., Silfee, VJ.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4683729/

The Happy Older Latinos are Active (HOLA) health promotion ... HOLA is a multi-component, health promotion intervention designed to prevent depression and anxiety in at-risk elderly Latinos. This prevention ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26683695/

The Happy Older Latinos are Active (HOLA) health promotion ... This pilot study tests the feasibility and acceptability of delivering HOLA to older, at-risk Latinos.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03870360

Preventing Anxiety and Depression in Older Hispanics This task is done in conjunction with the cool down of HOLA 2. Behavioral : HOLA Component 4. One booster walking session twice a month for six months post ...

4. ajgponline.org ajgponline.org/article/S1064-7481(17)30173-2/pdf

Preventing Anxiety in Depression in Older Latinos As a pilot study, the primary outcomes of interest were recruitment, adherence, retention and acceptability. Data were also collected on depression and anxiety ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03839212

The Happy Older Latinos Are Active (HOLA) Health ... The purpose of this study is to examine the feasibility of an intervention to prevent chronic diseases like diabetes, high blood pressure, and obesity in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6247898/

¡HOLA, Amigos! Toward Preventing Anxiety and ... HOLA is a multicomponent, health promotion intervention designed to use physical activity and social engagement to prevent depression and anxiety in at-risk ...

7. d-nb.info d-nb.info/1118316703/34

The Happy Older Latinos are Active (HOLA) health ... HOLA is a multi-component, health promotion interven- tion designed to prevent depression and anxiety in at-risk elderly Latinos. This prevention approach will ...