Potency and Precision Investigation

NCT06240091 | Completed Results FDA Device

• 1 other identifier: W-DISC-002
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression, Anxiety

Keywords

Woebot; Relational agent; Digital mental health intervention; Chatbot; Conversational agent; Natural language processing; Artificial intelligence

Outcome Measures

Primary Outcomes (1)

• Working Alliance Inventory-Short Revised (WAI-SR), Total Scale

  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.

  1 week and Post-treatment at 4 weeks

Study Arms (1)

DISC-MA

EXPERIMENTAL

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.

Device: DISC-MA

Interventions

DISC-MA 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.

DISC-MA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 18-75 years of age
• 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
• Must be available and committed to engage with the program and complete assessments for a 4-week duration
• Must be able to read and write in English
• Must have primary residence in the United States
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Woebot Health: lead

Study Sites (1)

Woebot Investigational Site

San Francisco, California, 94105, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Results Point of Contact

• Title: Tim Campellone, PhD
• Organization: Woebot Health

research@digitaltherapeutic.io

(415) 209-5642

Study Officials

• Tim Campellone, PhD

  Woebot Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 2, 2024
• Study Start: March 13, 2024
• Primary Completion: May 9, 2024
• Study Completion: May 9, 2024
• Last Updated: February 19, 2025
• Results First Posted: February 19, 2025

Record last verified: 2025-01

Locations

US (1)