Potency and Precision Investigation

Not Applicable

Completed

• Conditions: Depression, Anxiety
• Interventions: Device: DISC-MA

• Registration Number: NCT06240091
• Lead Sponsor: Woebot Health

Brief 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.

Study Timeline

• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-25
• Study First Posted: 2024-02-02
• Study Start: 2024-03-13
• Primary Completion: 2024-05-09
• Study Completion: 2024-05-09
• Status Verified: 2025-01
• Results First Submitted: 2025-01-27
• Results First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Results First Posted: 2025-02-19
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

1. Must be 18-75 years of age
2. Must own or have regular access to a smartphone with a recent operating system installed (Android: OS 8.0 or higher, Apple: iOS 13.0 or higher) with reliable Wi-Fi access or sufficient data plan to engage with assigned treatment condition for the duration of the study
3. Must be available and committed to engage with the program and complete assessments for a 4-week duration
4. Must be able to read and write in English
5. Must have primary residence in the United States
6. Must have mild or greater symptoms of depression and/or anxiety at Screening/Baseline, indicated by a score > 4 on the Patient Health Questionnaire (PHQ-8) and/or Generalized Anxiety Disorder (GAD-7)

Exclusion Criteria

1. Current suicidal ideation with a plan and/or intent or a suicide attempt within the past 12 months
2. Previous Woebot use
3. Involuntary inpatient psychiatric hospitalization any time within the past 30 days
4. Lifetime diagnosis of bipolar disorder
5. Lifetime diagnosis of a psychotic disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DISC-MA	DISC-MA	All participants will be asked to download and use the DISC-MA study application. They will have access to the app throughout the 4 week study.

Primary Outcome Measures

Name	Time	Method
Working Alliance Inventory-Short Revised (WAI-SR), Total Scale	1 week and Post-treatment at 4 weeks	Measure of working alliance. A 12-item measure that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy, and (c) development of an affective bond. For the purposes of the study, the word "therapist" was replaced with "Woebot". Total mean scores range from 1-5, with higher scores indicating greater alliance between the participant and Woebot.

Trial Locations

Locations (1)

Woebot Investigational Site; 🇺🇸 San Francisco, California, United States