Participant Satisfaction With the BUILD Mobile Application

Satisfaction, Personal Clinical Trial

Official title:

An Exploratory Randomized Controlled Trial of Participant Satisfaction With the BUILD Mobile Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05948670
• Other study ID #: W-DISC-001
• Status: Completed
• Phase: N/A
• Start date: October 4, 2023
• Est. completion date: November 15, 2023

Study information

• Verified date: January 2024
• Source: Woebot Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study explores user satisfaction with the BUILD mobile application.

Description:

This exploratory randomized, double-blind, controlled trial explores user satisfaction with the BUILD mobile application. The BUILD app uses a relational agent (Woebot) to engage users in therapeutic conversations. Eligible participants will be randomized to one of two treatment conditions: (1) an experimental condition in which Woebot uses large language models to understand user sentiment, and based on this understanding of natural language generate responses through a controlled process or (2) a digital control condition in which Woebot selects from a list of responses based on natural language processing. Participants will receive instructions on downloading and using the BUILD app in order to access the intervention to which they were assigned. Participants will use the app as instructed and will complete assessments for the primary endpoint at Week 2 (EOT) with additional measures being collected at Baseline, Day 3, and Week 2. Results from this study will provide preliminary data on user satisfaction and feasibility and inform product development iteration for inclusion in a statistically powered clinical randomized controlled trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: November 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Must be 18+ years of age and older

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 2-week duration

4. Must be able to read and write in English

5. Must have primary residence in the United States

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

Related Conditions & MeSH terms

• Satisfaction, Personal

Intervention

Device:
• DISC-MVP
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-CON
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.

Locations

Country	Name	City	State
United States	Woebot Investigational Site	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Woebot Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	User satisfaction amongst a sub-sample of adults with at least mild symptoms of depression and/or anxiety.	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