NCT05948670

Participant Satisfaction With the BUILD Mobile Application

An Exploratory Randomized Controlled Trial of Participant Satisfaction With the BUILD Mobile Application

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Woebot Health · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study explores user satisfaction with the BUILD mobile application.

Detailed description

This exploratory randomized, double-blind, controlled trial explores user satisfaction with the BUILD mobile application. The BUILD app uses a relational agent (Woebot) to engage users in therapeutic conversations. Eligible participants will be randomized to one of two treatment conditions: (1) an experimental condition in which Woebot uses large language models to understand user sentiment, and based on this understanding of natural language generate responses through a controlled process or (2) a digital control condition in which Woebot selects from a list of responses based on natural language processing. Participants will receive instructions on downloading and using the BUILD app in order to access the intervention to which they were assigned. Participants will use the app as instructed and will complete assessments for the primary endpoint at Week 2 (EOT) with additional measures being collected at Baseline, Day 3, and Week 2. Results from this study will provide preliminary data on user satisfaction and feasibility and inform product development iteration for inclusion in a statistically powered clinical randomized controlled trial.

Conditions

• Satisfaction, Personal

Interventions

Type	Name	Description
DEVICE	DISC-MVP	DISC-MVP is a digital program grounded in validated psychotherapies (e.g., cognitive behavioral therapy), that enlists a relational agent (Woebot) to engage users in therapeutic conversations and generates responses through a controlled process using large language models.
DEVICE	DISC-CON	DISC-CON is a digital program grounded in validated psychotherapies (e.g., including cognitive behavioral therapy) that uses a virtual relational agent (Woebot) to engage users in therapeutic conversations with responses that are selected from a list based on natural language processing.

Timeline

• Start date: 2023-10-04
• Primary completion: 2023-11-15
• Completion: 2023-11-15
• First posted: 2023-07-17
• Last updated: 2025-02-18
• Results posted: 2025-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study