Participant Satisfaction With the BUILD Mobile Application

Study Overview
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Brief Summary
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This study explores user satisfaction with the BUILD mobile application.

Detailed Description
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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.

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

Conditions
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Satisfaction, Personal

Intervention / Treatment
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* Device: DISC-MVP
* Device: DISC-CON


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 randomization
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DISC-MVP<br>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<br>* 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.<br>|
| Active Comparator: DISC-CON<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Woebot, LLM, Relational agent