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OpenTrials
Completed

NCT Number: NCT05948670

Participant Satisfaction With the BUILD Mobile Application

This study explores user satisfaction with the BUILD mobile application.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Woebot Investigational Site

San Francisco, California, 94105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Current suicidal ideation with a plan and/or intent or a suicide attempt within the past 12 months
  • Previous Woebot use

Treatment and study plan

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-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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Woebot Health

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 17, 2023
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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