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

240 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Healthy lifestyles education program, HOLA Component 1, HOLA Component 2, HOLA Component 3, HOLA Component 4 for preventing anxiety and depression?

Research shows that lifestyle interventions can improve physical health and reduce risk factors like obesity and metabolic syndrome in people with mental health issues, which are linked to anxiety and depression. Programs that educate and involve caregivers have been successful in promoting healthy lifestyle changes. ^{1 2 3 4 5}

Is the Healthy Lifestyles Education program safe for humans?

The available research on various healthy lifestyle education programs, including those for mental health patients and hospital staff, generally shows positive feedback and no reported safety concerns. These programs focus on promoting awareness and healthy behaviors, suggesting they are safe for human participants. ^{1 6 7 8 9}

How does the Healthy Lifestyles Education Program treatment differ from other treatments for preventing anxiety and depression?

The Healthy Lifestyles Education Program is unique because it focuses on teaching healthy lifestyle behaviors to prevent anxiety and depression, rather than using medication or traditional therapy. This approach emphasizes lifestyle changes, such as diet and exercise, to improve mental health, which is different from other treatments that might rely on medication or psychological therapy alone. ^{10 11 12 13 14}

What is the purpose of this trial?

The purpose of this study is to look at the best ways to prevent anxiety and depression in older Latino adults who are at risk for developing anxiety and depression. Participants will be randomized to either a health promotion intervention or a healthy lifestyles education program.

Research Team

Daniel Jimenez, Ph.D.

Principal Investigator

University of Miami

Eligibility Criteria

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

You identify yourself as Latino.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Addressing the health and lifestyle issues of people with a mental illness: the Healthy Living Programme. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Lifestyle interventions for adults with serious mental illness: a systematic literature review. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Teaching staff a brief cognitive-behavioral intervention. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Physical health--a cluster randomized controlled lifestyle intervention among persons with a psychiatric disability and their staff. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Improving physical health of patients with severe mental disorders: a critical review of lifestyle psychosocial interventions. [2019]

6. England pubmed.ncbi.nlm.nih.gov

The effect of lifestyle-based education to women and their husbands on the anxiety and depression during pregnancy: a randomized controlled trial. [2017]

7. Australia pubmed.ncbi.nlm.nih.gov

Towards a healthier lifestyle for staff of a psychiatric hospital: description of a pilot programme. [2005]

8. United States 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. [2020]

9. Australia pubmed.ncbi.nlm.nih.gov

A healthy lifestyle education programme for health literacy and health-promoting behaviours: A pre-implementation and post-implementation study. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Lifestyle Behaviors, Depression, and Anxiety Among Individuals Living in Canada During the COVID-19 Pandemic. [2023]

11. Australia pubmed.ncbi.nlm.nih.gov

Review of internet-based prevention and treatment programs for anxiety and depression in children and adolescents. [2022]

12. Japan pubmed.ncbi.nlm.nih.gov

Changes of levels of depression and quality of life after short-term cognitive behavioral educational program for adolescent students in health class. [2017]

13. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The efficiency of psychological educational programs under depressive disorders]. [2016]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Randomized Clinical Trial of an Internet-Based Adolescent Depression Prevention Intervention in Primary Care: Internalizing Symptom Outcomes. [2021]