Participant Satisfaction With the BUILD Mobile Application

• Sponsor: Woebot Health (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05948670
• Collaborator: (none)
• Enrollment: 150
• Arms: 2
• Anticipated Duration (Months): 3

Study Details

Study Description

Brief Summary

This study explores user satisfaction with the BUILD mobile application.

Condition or Disease	Intervention/Treatment	Phase
Satisfaction, Personal	Device: DISC-MVP; Device: DISC-CON	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 1:1 randomization1:1 randomization
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: An Exploratory Randomized Controlled Trial of Participant Satisfaction With the BUILD Mobile Application
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DISC-MVP 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-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.
Active Comparator: DISC-CON 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; 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.

Outcome Measures

Primary Outcome Measures

1. User satisfaction as measured by the Client Satisfaction Questionnaire (CSQ-8) [Post-intervention at Week 2]

   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.

Secondary Outcome Measures

1. User satisfaction amongst a sub-sample of adults with at least mild symptoms of depression and/or anxiety. [Post-intervention at Week 2]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Woebot Health

Investigators

• Principal Investigator: Tim Campellone, PhD, Woebot Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Woebot Health
• ClinicalTrials.gov Identifier: NCT05948670
• Other Study ID Numbers: W-DISC-001
• First Posted: Jul 17, 2023
• Last Update Posted: Jul 17, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Woebot Health: Woebot; LLM; Relational agent

Study Results

No Results Posted as of Jul 17, 2023