Potency and Precision Investigation

NCT ID: NCT06240091

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-13
• Study Completion Date: 2024-05-09

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.

Conditions

Depression, Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

DISC-MA

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Woebot Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tim Campellone, PhD

Role: PRINCIPAL_INVESTIGATOR

Woebot Health

Locations

Woebot Investigational Site

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

W-DISC-002

Identifier Type: -

Identifier Source: org_study_id