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This study explores user satisfaction with the BUILD mobile application.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Campellone, PhD | Woebot Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woebot Investigational Site | San Francisco | California | 94105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40408143 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Post-intervention at Week 2 |
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening physical health condition | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tim Campellone, PhD | Woebot Health | (415) 209-5642 | research@digitaltherapeutic.io |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 8, 2023 | Nov 11, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D001519 | Behavior |
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1:1 randomization
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| 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. |
|
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| 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. 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. |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Post-intervention at Week 2 |
|
|
|
| 0 |
| 87 |
| 0 |
| 87 |
| 1 |
| 87 |
| EG001 | 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. 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. | 0 | 88 | 0 | 88 | 7 | 88 |
| Worsening mental health condition | Psychiatric disorders | Systematic Assessment |
|
| New physical health condition | General disorders | Systematic Assessment |
|
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