Evaluating a Digital Intervention to Improve Resilience and Reduce Stress in Stanford Populations

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
Primary Objective To evaluate whether engagement with the WONE app improves resilience,emotional well‐being, and stress management outcomes among Stanford‐affiliated adults.Secondary Objective To evaluate the feasibility of wearable‐device integration.Rationale for Two‐Phase Structure This protocol includes two sequential studies. 1. Phase 1 (Pilot): A single‐arm feasibility pilot designed to assess acceptability ofthe WONE digital intervention, verify that onboarding, survey workflows, and datacapture function smoothly, and identify any usability issues before running arandomized trial. 2. Phase 2 (Randomized Crossover RCT): A fully powered evaluation of the efficacy ofWONE, using a 12‐week crossover design to compare intervention vs. control periods,followed by a 6‐month follow‐up to evaluate maintenance of effects.Phase 1 Objectives (Pilot) 1. Assess feasibility and acceptability of the WONE digital intervention over 8 weeks. 2. Evaluate preliminary changes in resilience, emotional well‐being, and stressmanagement from baseline to Week 8. Secondary analysis will also explore changes insymptoms related to anxiety and depression. 3. Describe engagement patterns and examine whether engagement relates to changes inoutcomes. 4. Assess feasibility of wearable integration, including connection rates and datacompleteness.Phase 2 Objectives (Randomized Crossover RCT) 1. Test the efficacy of the WONE intervention compared to a control period using a12‐week crossover design. 2. Examine changes in resilience, emotional well‐being, and stress management acrossintervention vs. control phases. Secondary analysis will also explore changes insymptoms related to anxiety and depression. 3. Investigate engagement as a predictor of improvement. 4. Evaluate maintenance of effects at the 6‐month follow‐up.
Epistemonikos ID: 8ebf25584d6316a32d69c73a039a83e60c6fec8d
First added on: May 05, 2026