Web-App Based Physical Activity Program for Depression

Recruiting at 1 trial location

Overseen By Wonshik Chee, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Texas at Austin

Must not be taking: Beta-blockers, Diltiazem, Verapamil

Disqualifiers: Pulmonary, CVD, Myocardial infarction, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a web-based program can improve depression symptoms in midlife Korean American women. Participants will either use a lifestyle activity app (Lifestyle Physical Activity Promotion Program) or access general health information through a CDC website for a year. The goal is to determine if integrating physical activity into daily life via an app affects depression management. Women who identify as Korean American, are between 40 and 60, and have recently experienced depression may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance mental health support for Korean American women.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use beta-blockers, diltiazem, or verapamil.

What prior data suggests that this web app-based program is safe for participants?

Research has shown that digital and mobile phone programs promoting physical activity can help reduce depression. Studies have found that these programs improve symptoms of depression, particularly when tailored to different cultural needs.

While specific safety information on these programs is lacking, promoting physical activity through a web app is generally safe for most people. No reports have indicated negative effects directly caused by using web apps for this purpose. Lifestyle programs like this one aim to encourage healthy habits, which are usually well-tolerated.

Participants considering joining a trial should discuss any health concerns with the research team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Web-App Based Physical Activity Program for depression because it offers a fresh approach to managing mental health. Unlike traditional treatments like medication and therapy, this program leverages technology to promote lifestyle changes, encouraging participants to engage in physical activity through a convenient web app. This method not only empowers individuals to take an active role in their treatment but also integrates seamlessly into daily life, potentially enhancing adherence and long-term mental health outcomes. By focusing on physical activity, this program taps into the well-documented benefits of exercise on mood improvement, providing a non-invasive, side-effect-free option for individuals battling depression.

What evidence suggests that this Web App-based program is effective for depression?

Research has shown that physical activity can greatly alleviate depression. In this trial, participants in the intervention group will use a web app-based program, WPAPP-K, designed to encourage physical activity. This program has effectively reduced depression. Additionally, studies have indicated that a web-based program for Asian American midlife women can decrease symptoms of depression. These programs promote regular exercise, which improves mood and mental health. This suggests that using a web app to encourage physical activity might help reduce depression in midlife Korean American women. ^{1 2 3 4 6}

Who Is on the Research Team?

Eun-Ok Im, PhD, MPH

Principal Investigator

The University of Texas at Austin

Are You a Good Fit for This Trial?

This trial is for midlife Korean-American women aged 40-60, living in the U.S., who have minimal to moderate depression and are sedentary but can engage in physical activity. Participants must be able to use a computer or mobile device and read/write English or Korean.

Inclusion Criteria

I do not engage in regular physical activity but have no disabilities preventing it.

who can read and write English or Korean;

I am between 40 and 60 years old.

Exclusion Criteria

I show major signs or symptoms of heart or lung disease.

I have had a heart attack, stroke, or Type I diabetes.

I am taking beta-blockers, diltiazem, or verapamil.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage with the Web App-based Lifestyle Physical Activity Promotion Program (WPAPP-K) for 12 months

12 months

Participants are asked to visit WPAPP-K at least two times a week

Follow-up

Participants are monitored for changes in depressive symptoms, physical activity, and other health metrics

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Lifestyle Physical Activity Promotion Program

Trial Overview The study tests if a Web App-based Lifestyle Physical Activity Promotion Program can improve depressive symptoms compared to standard CDC guidelines on depression and physical activity for midlife Korean American women.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 2 Interventions

Participants will be asked to visit WPAPP-K at least two times a week for 12 months.

Group II: Control group Active Control 1 Intervention

Participants will have access to a link of the CDC website from baseline and during the duration of the study (12 months).

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

The American College of Sports Medicine and Kaiser Permanente recommend implementing a Physical Activity Vital Sign (PAVS) at every medical visit to address the issues of physical inactivity and sedentary lifestyles in the U.S. population.

This initiative aims to engage both clinicians and patients in promoting physical activity as a crucial component of health care, potentially reducing the risk of chronic diseases associated with low cardiorespiratory fitness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Call to Action on Making Physical Activity Assessment and Prescription a Medical Standard of Care. Sallis, RE., Matuszak, JM., Baggish, AL., et al.[2017]

A systematic review of 17 studies on second and third generation computer-tailored interventions for increasing physical activity found that 10 out of 16 interventions showed significant positive effects on physical activity or weight reduction.

Despite the potential of these tailored programs to reach large populations, the overall effectiveness remains inconclusive, with questions about the generalizability and sustainability of the reported benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-tailored physical activity behavior change interventions targeting adults: a systematic review. Neville, LM., O'Hara, B., Milat, A.[2022]

The enhanced Internet program (EI) significantly increased physical activity (PA) levels among participants compared to standard Internet resources (SI) after 3 months, with participants in the EI group exercising an average of 186.0 minutes per week versus 57.3 minutes in the SI group.

However, by 6 months, the differences in PA levels between the two groups were no longer significant, indicating that while the EI program was effective in the short term, strategies for maintaining increased PA over the long term need further exploration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial testing an internet physical activity intervention for sedentary adults. Carr, LJ., Dunsiger, SI., Lewis, B., et al.[2022]

The Activity Promotion System (APs) effectively reduced sedentary time and increased physical activity levels, including daily step counts and calories burned, in a six-month study involving 53 overweight participants with metabolic abnormalities.

However, while APs showed some short-term benefits in physical activity, they did not significantly improve metabolic profiles, except for a slight reduction in waist circumference, indicating the need for further long-term studies to assess their overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of an Activity Promotion System on active living in overweight subjects with metabolic abnormalities. Yang, YP., Wang, CJ., Wang, JJ., et al.[2018]

Physical activity (PA) programs have proven benefits for individuals with severe mental illness (SMI), but there is a need for more practical and sustainable implementation in mental health settings.

Successful PA interventions in Australia demonstrate various modes and intensities of service delivery, and adopting specific strategies can enhance access and effectiveness of these programs for mental health service users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embedding exercise interventions as routine mental health care: implementation strategies in residential, inpatient and community settings. Lederman, O., Suetani, S., Stanton, R., et al.[2019]

The PACINPAT trial successfully reached its target population of 95 physically inactive in-patients with major depressive disorder, demonstrating the feasibility of implementing a tailored physical activity counseling intervention.

Participants showed high satisfaction with the intervention, and while the dosage of counseling varied significantly among individuals, adaptations were made to improve both in-person and remote counseling delivery, which is crucial for future implementation and outcome analyses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An implementation evaluation of the physical activity counseling for in-patients with major depressive disorder (PACINPAT) intervention: a randomized controlled trial. Cody, R., Kreppke, JN., Fischer, X., et al.[2023]

The eMotion intervention, which combines behavioral activation and physical activity promotion, was feasible to deliver to people with depression in UK communities, with 62 participants recruited and randomized over an 8-week period.

Participants in the eMotion group showed a significant reduction in depression symptoms compared to the control group, with an adjusted mean difference of -3.6 on the PHQ-8 scale, indicating potential effectiveness for future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Intervention Using Behavioral Activation and Physical Activity for Adults With Depression (The eMotion Study): Pilot Randomized Controlled Trial. Lambert, JD., Greaves, CJ., Farrand, P., et al.[2019]

The study will evaluate the effectiveness of a blended intervention combining personalized exercise plans with psychological support for improving mental health in 172 participants with mild to moderate depressive symptoms.

Participants will be divided into three groups to assess the impact of motivational messaging on adherence to exercise, with outcomes measured at multiple time points over 36 weeks, aiming to enhance both mental and physical health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Depressive Symptoms through Personalised Exercise and Activation (IDEA): Study Protocol for a Randomised Controlled Trial. García-Estela, A., Angarita-Osorio, N., Alonso, S., et al.[2021]

The Activity Point System (APS) offers a semiquantitative method for healthcare providers to prescribe exercise tailored to individual body weight, BMI, and activity intensity, making it easier for patients to understand their exercise goals.

By aiming for 100-300 activity points per week, the APS motivates overweight and obese adults to engage in physical activity, promoting healthier lifestyles in a structured way.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise prescription for the overweight and the obese: how to quantify and yet keep it simple. Ehrsam, R., Hoerler-Koerner, U., Stoffel, S., et al.[2018]

The ONWARDS study is a randomized control trial involving 180 inactive adults in Northern Norway, testing the effectiveness of different combinations of digital interventions (activity trackers, online training videos, and peer support) over 18 months to increase physical activity levels and promote long-term exercise adherence.

The study aims to address physical inactivity, a major risk factor for lifestyle diseases, by providing accessible home-based interventions that could potentially be integrated into national health systems if proven effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital interventions to promote physical activity among inactive adults: A study protocol for a hybrid type I effectiveness-implementation randomized controlled trial. Zanaboni, P., Manskow, US., Sagelv, EH., et al.[2023]

The Internet-based physical activity support program (IPAS) did not show significant improvements in moderate-to-vigorous physical activity (MVPA) or secondary outcomes among 137 cancer survivors compared to a control group after 6 months.

Blended care, which included physiotherapist telephone counseling, received better satisfaction scores than online-only support, but overall adherence to the program was low, indicating a need for improved accessibility and support in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of and Lessons Learned from an Internet-Based Physical Activity Support Program (with and without Physiotherapist Telephone Counselling) on Physical Activity Levels of Breast and Prostate Cancer Survivors: The PABLO Randomized Controlled Trial. van de Wiel, HJ., Stuiver, MM., May, AM., et al.[2021]

In a study involving 36 patients with major depressive disorder, many found the Fitbit helpful for increasing physical activity, highlighting benefits like self-awareness and goal-setting, which align with existing research on physical activity and depression.

However, some patients reported negative experiences, such as inconvenience and inaccuracies, indicating that while Fitbits can be beneficial, their limitations should be considered when used alongside behavioral activation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of the Fitbit in behavioural activation therapy for depression: a qualitative study. Chum, J., Kim, MS., Zielinski, L., et al.[2023]

In a randomized nine-week trial involving 48 participants with mild to moderate depression, those receiving guided Internet-administered physical exercise showed a significant reduction in depressive symptoms compared to a control group, with a moderate effect size (Cohen's d = 0.67).

The benefits of the Internet-based physical activity program persisted even six months after the treatment, demonstrating its potential as a long-term intervention for managing depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered therapist-guided physical activity for mild to moderate depression: a randomized controlled trial. Ström, M., Uckelstam, CJ., Andersson, G., et al.[2022]

HIV-positive adults engage in less moderate-to-vigorous physical activity (33 minutes per day) compared to HIV-uninfected controls (48 minutes per day), which may contribute to their poorer cardiovascular health.

Despite the lower levels of physical activity, the study found no significant association between physical activity and cardiovascular fitness markers (like peak VO2) in HIV-positive adults, suggesting that HIV infection may limit the benefits of physical activity on cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Influence of Exercise on Cardiovascular Health in Sedentary Adults With Human Immunodeficiency Virus. Webel, AR., Perazzo, J., Longenecker, CT., et al.[2019]

Citations

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Testing Adaptive Interventions to Improve Physical Activity for ... This study aims to determine the most effective adaptive intervention combining four efficacious treatments (enhanced PA monitor, motivational text messages, ...

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What is WPAPP study? The purpose of this study is to determine the efficacy of the Web-App based Lifestyle Physical Activity Promotion Program in improving depressive symptom ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6585067/

The impact of lifestyle Physical Activity Counselling in IN ... This study will examine the impact of a lifestyle physical activity counselling intervention on physical activity, cardiorespiratory fitness, depression, and ...

4. mhealth.jmir.org mhealth.jmir.org/2023/1/e46286

The Effectiveness of a Mobile Phone–Based Physical Activity ... This study provided experimental evidence that mobile phone–based physical activity program affects depression significantly.

5. sciencedirect.com sciencedirect.com/org/science/article/pii/S1438887125004054

Effectiveness of Digital Lifestyle Interventions on ... The effect of a culturally tailored web-based physical activity promotion program on Asian American midlife women's depressive symptoms.

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/93/NCT02360293/Prot_SAP_000.pdf

VA Central IRB Protocol Template Veterans from Afghanistan and Iraq (OEF/OIF/OND) are at high risk for becoming overweight and obese; 86% were overweight or obese at their first visit to ...