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

Trial Summary

What is the purpose of this trial?

This study is being done to answer a question on whether a Web App-based Lifestyle Physical Activity Promotion Program is effective in improving depressive symptom experience of midlife Korean American women (WPAPP-K).

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 data supports the effectiveness of the Web-App Based Physical Activity Program for Depression treatment?

Research shows that physical activity can help reduce symptoms of depression, and web-based programs like eMotion, which combine physical activity with behavioral activation (a therapy that encourages engagement in positive activities), have shown promise in supporting people with depression to become more active. Additionally, computer-tailored programs have been effective in changing lifestyle behaviors, suggesting that web-based physical activity programs could be beneficial for mental health. ^{1 2 3 4 5}

Is the Web-App Based Physical Activity Program for Depression safe for humans?

The research suggests that promoting physical activity through digital interventions is generally safe for humans, as it is often recommended to improve health and reduce the risk of chronic diseases. However, specific safety data for the Web-App Based Physical Activity Program for Depression is not directly available in the provided studies. ^{6 7 8 9 10}

How is the Web-App Based Physical Activity Program for Depression different from other treatments for depression?

This treatment is unique because it uses a web app to promote physical activity as a way to help manage depression, combining exercise with behavioral activation (a therapy that encourages engagement in positive activities). Unlike traditional treatments that may rely on medication or in-person therapy, this program offers a flexible, internet-based approach that can be accessed from home. ^{1 11 12 13 14}

Research Team

Eun-Ok Im, PhD, MPH

Principal Investigator

The University of Texas at Austin

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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]

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]

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]

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 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]

References

1. Canada 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. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Computer-tailored physical activity behavior change interventions targeting adults: a systematic review. [2022]

3. Switzerland 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. [2021]

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

Embedding exercise interventions as routine mental health care: implementation strategies in residential, inpatient and community settings. [2019]

5. England 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. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The Effects of an Activity Promotion System on active living in overweight subjects with metabolic abnormalities. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Exercise prescription for the overweight and the obese: how to quantify and yet keep it simple. [2018]

8. Switzerland 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. [2023]

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

The Influence of Exercise on Cardiovascular Health in Sedentary Adults With Human Immunodeficiency Virus. [2019]

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

Call to Action on Making Physical Activity Assessment and Prescription a Medical Standard of Care. [2017]

11. England pubmed.ncbi.nlm.nih.gov

Acceptability of the Fitbit in behavioural activation therapy for depression: a qualitative study. [2023]

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

Internet-delivered therapist-guided physical activity for mild to moderate depression: a randomized controlled trial. [2022]

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

Randomized controlled trial testing an internet physical activity intervention for sedentary adults. [2022]

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

Improving Depressive Symptoms through Personalised Exercise and Activation (IDEA): Study Protocol for a Randomised Controlled Trial. [2021]