Digital Intervention for Psychological Resilience

(SIER-WONE Trial)

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AY
Overseen ByAlan Yeung, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital app called WONE, designed to help high-achieving academics and entrepreneurs manage stress and build resilience. Participants will use different versions of the app to evaluate its effectiveness in reducing stress and burnout. The trial involves using the app over a set period and completing related activities and surveys. Ideal participants are affiliated with Stanford, have a smartphone with internet access, and are willing to engage with the app regularly. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance stress management tools for high achievers.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on digital interventions, so it's likely you can continue your medications, but you should confirm with the trial organizers.

What prior data suggests that the WONE App is safe for users?

Research has shown that mental health apps, such as the WONE app, can safely and effectively improve mental well-being. Many users find these apps provide quick support and make mental health care more accessible. However, concerns about data safety and privacy persist. These apps may not fully protect personal information, so consider how your data might be used.

The WONE app includes tools to assess stress and offers small activities to help manage it. Although specific safety data for the WONE app is unavailable, similar apps are generally safe to use. Most users do not report serious side effects. Nonetheless, exercise caution when sharing personal information through the app.12345

Why are researchers excited about this trial?

Researchers are excited about the WONE App because it offers a digital approach to building psychological resilience, setting it apart from traditional therapy and medication options. Unlike standard treatments that often involve face-to-face therapy sessions or medications, the WONE App provides flexibility and accessibility through a mobile platform. It offers two versions: a control version with limited features and an intervention version with full features, allowing researchers to assess the app's impact over different periods. This digital intervention could make mental health support more accessible and convenient, especially for those who might have barriers to traditional therapy.

What evidence suggests that the WONE App is effective for stress and resilience support?

Research has shown that the WONE app, a digital tool for managing stress and building resilience, could improve mental health. In this trial, participants will use different versions of the WONE app. The WONE Index, a feature of the app, strongly correlates with better mental health outcomes and outperforms some traditional methods of measuring resilience. Studies indicate that mobile apps can effectively help with depression and anxiety. Evidence suggests that mental health apps can assist in managing stress and improving well-being. These findings imply that the WONE app could be a useful tool for reducing stress and building resilience in stressful situations.26789

Who Is on the Research Team?

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Alan Yeung, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who are affiliated with Stanford, live in the US, speak English, have a smartphone and internet access, and are willing to use an app and complete surveys. People with recent severe mental health crises or major daily life impairments cannot join.

Inclusion Criteria

I am between 18 and 65 years old and affiliated with Stanford.
English proficiency with the ability to read, write, and complete surveys in English
Smartphone with internet access
See 4 more

Exclusion Criteria

Severe psychiatric instability, defined as any of the following self-reported on the pre-enrollment screener: Psychiatric hospitalization for a mental health crisis in the past 12 months, Current mental health symptoms that significantly impair ability to function in daily life (e.g., unable to work, attend school, or care for basic needs)
No smartphone or unwilling to consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 (Pilot)

Assess feasibility and acceptability of the WONE digital intervention over 8 weeks

8 weeks
Participants complete assessments at baseline, week 4, and week 8

Phase 2 (Randomized Crossover RCT)

Test the efficacy of the WONE intervention using a 12-week crossover design

24 weeks
Participants complete assessments at baseline, week 4, week 8, week 12, week 16, week 20, and week 24

Follow-up

Evaluate maintenance of effects at the 6-month follow-up

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • WONE App

Trial Overview

The study tests the WONE app—a digital tool offering personalized stress assessments and short science-based activities—to see if it helps reduce stress and build resilience among Stanford-affiliated participants. Some may also use wearable devices for extra feedback.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Phase 2: Intervention (Weeks 1-12) then Control (Weeks 13-24)Experimental Treatment1 Intervention
Group II: Phase 2: Control (Weeks 1-12) then Intervention (Weeks 13-24)Experimental Treatment1 Intervention
Group III: Phase 1 (pilot, single arm)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Walking on Earth Ltd.

Collaborator

Citations

Smartphone apps for mental health: systematic review ... - PMC

This systematic review assessed the clinical effectiveness (primary outcome), feasibility and acceptability (secondary outcomes) of mental ...

Efficacy of standalone smartphone apps for mental health

The use and effectiveness of mobile apps for depression: results from a fully remote clinical trial. J Med Internet Res. 2016; 18, e330.

Effectiveness of evidence based mental health apps on ...

This study evaluates the effectiveness of evidence-based health apps on user mental health outcomes, particularly depression, anxiety, and ...

The WONE Index as a Multidimensional Assessment of Stress ...

Notably, the WONE Index demonstrated stronger correlations with mental health outcomes than established resilience measures and comparable ...

The WONE Index as a Multidimensional Assessment of ...

WONE Index provides a meaningful prediction of mental health outcomes beyond established measures. Models tested incremental validity beyond ...

The WONE Index: A New Standard for Measuring Stress ...

of the WONE Index. This innovative tool moves beyond static traits to measure stress resilience as a dynamic balance between life's demands and ...

Use of generative AI chatbots and wellness applications for ...

Recommendations to ensure consumer safety and well-being when using chatbots and apps to address unmet mental health needs.

Experiences of Using Mental Health Apps to Support ...

MHApps are a new strand of apps available on a smartphone or tablet to support people with their psychological health and wellbeing.

Mental Health Apps Are Not Keeping Your Data Safe

Many apps that provide mental health services are based on artificial intelligence algorithms that haven't been properly vetted for ethical and moral concerns.