NCT06240091

Potency and Precision Investigation

An Exploratory Open-Label Potency and Precision Investigation of a Relational Agent Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Woebot Health · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The overarching goal of this study is to establish initial proof of mechanism for precision interventions in an adult population.

Detailed description

This exploratory single-arm trial will provide initial learning on the current implementation of precision interventions and generate data and hypotheses to inform the exploration of future interventions by identifying mechanisms and moments in the user journey to target. The DISC-MA app uses a relational agent (Woebot) to engage users in conversations. Eligible participants will be assigned to use DISC-MA, in which Woebot selects from a list of responses based on natural language processing. Participants will receive instructions on downloading and using the DISC-MA app in order to access the intervention. Participants will use the app as instructed and will complete assessments for the primary endpoint as Week 4 (EOT) with additional measures being collected as Baseline, Week 1, and Week 2. Results from this study will provide data on baseline participant clinical and psychological characteristics and their engagement with DISC-MA, and associations between the two.

Conditions

• Depression, Anxiety

Interventions

Type	Name	Description
DEVICE	DISC-MA	DISC-MA is a digital program that utilizes elements from validated psychotherapies (e.g., cognitive behavioral therapy), with a relational agent (Woebot) that engages users in conversations with responses that are selected from a list based on natural language processing.

Timeline

• Start date: 2024-03-13
• Primary completion: 2024-05-09
• Completion: 2024-05-09
• First posted: 2024-02-02
• Last updated: 2025-02-19
• Results posted: 2025-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study