Potency and Precision Investigation (PAPI)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Depression, Anxiety
• Intervention / Treatment: Device: DISC-MA

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 Type: Interventional
• Enrollment (Actual): 203
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tim Campellone, PhD; Phone Number: (415) 209-5642; Email: research@digitaltherapeutic.io

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94105
      • Woebot Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Woebot Health
• Investigators: Principal Investigator: Tim Campellone, PhD, Woebot Health

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Artificial intelligence; Chatbot; Natural language processing; Digital mental health intervention; Conversational agent; Relational agent; Woebot
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: W-DISC-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No