Participant Satisfaction With the BUILD Mobile Application

NCT05948670 | Completed Results FDA Device

• 1 other identifier: W-DISC-001
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

This study explores user satisfaction with the BUILD mobile application.

Conditions

Satisfaction, Personal

Keywords

Woebot; LLM; Relational agent

Outcome Measures

Primary Outcomes (1)

• User Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ-8)

  The CSQ-8 is an 8-item measure used to assess client's satisfaction with treatment.Total scores range from 8-32, with high scores indicating greater satisfaction with the treatment.

  Post-intervention at Week 2

Secondary Outcomes (1)

• User Satisfaction Amongst a Sub-sample of Adults With at Least Mild Symptoms of Depression and/or Anxiety.

  Post-intervention at Week 2

Study Arms (2)

DISC-MVP

EXPERIMENTAL

Participants randomized to the experimental condition, DISC-MVP, will be asked to download and use the BUILD study application. They will have access to the app throughout the 2 week study.

Device: DISC-MVP

DISC-CON

ACTIVE COMPARATOR

Participants randomized to the digital control condition, DISC-CON, will be asked to download and use the BUILD study application. They will have access to the app throughout the 2 week study.

Device: DISC-CON

Interventions

DISC-MVP DEVICE

DISC-MVP is a digital program grounded in validated psychotherapies (e.g., cognitive behavioral therapy), that enlists a relational agent (Woebot) to engage users in therapeutic conversations and generates responses through a controlled process using large language models.

DISC-MVP

DISC-CON DEVICE

DISC-CON is a digital program grounded in validated psychotherapies (e.g., including cognitive behavioral therapy) that uses a virtual relational agent (Woebot) to engage users in therapeutic conversations with responses that are selected from a list based on natural language processing.

DISC-CON

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 18+ years of age and older
• 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 2-week duration
• Must be able to read and write in English
• Must have primary residence in the United States

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

Sponsors & Collaborators

• Woebot Health: lead

Study Sites (1)

Woebot Investigational Site

San Francisco, California, 94105, United States

Location

Related Publications (1)

• Campellone TR, Flom M, Montgomery RM, Bullard L, Pirner MC, Pavez A, Morales M, Harper D, Oddy C, O'Connor T, Daniels J, Eaneff S, Forman-Hoffman VL, Sackett C, Darcy A. Safety and User Experience of a Generative Artificial Intelligence Digital Mental Health Intervention: Exploratory Randomized Controlled Trial. J Med Internet Res. 2025 May 23;27:e67365. doi: 10.2196/67365.

  PMID: 40408143 DERIVED

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 17, 2023
• Study Start: October 4, 2023
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: February 18, 2025
• Results First Posted: January 7, 2025

Record last verified: 2025-01

Locations

US (1)