Satisfaction, PersonalNCT05948670
Participant Satisfaction With the BUILD Mobile Application
A study testing DISC-MVP and DISC-CON in people with Satisfaction, Personal, run by Woebot Health at 1 site in United States.
Trial summary
This study explores user satisfaction with the BUILD mobile application. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Satisfaction, Personal
- What is being tested?
- DISC-MVP and DISC-CON
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2023to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current suicidal ideation with a plan and/or intent or a suicide attempt within the past 12 months
- Previous Woebot use
Trial locations and contacts
1 site in 1 country.
United States1 site
Woebot Investigational Site
San Francisco, California, 94105
About this study
Official title: An Exploratory Randomized Controlled Trial of Participant Satisfaction With the BUILD Mobile Application
This study explores user satisfaction with the BUILD mobile application.
Read the 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.
- Conditions
- Satisfaction, Personal
- Being tested
- DISC-MVP, DISC-CON
- Keywords
- Woebot, LLM, Relational agent
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DISC-MVPDevice
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-CONDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: DISC-MVP |
| 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. Receives: Device: DISC-CON |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-intervention at Week 2
Secondary outcomes (1)
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.
Measured: Post-intervention at Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start4 Oct 2023
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Satisfaction, PersonalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woebot Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim Campellone, PhD, Principal investigator, Woebot Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948670
- Sponsor's protocol ID
- W-DISC-001
- Status last verified
- Jan 2025
- First submitted
- 23 Jun 2023
- Last updated
- 18 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 40408143
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Randomized Controlled Trial of Participant Satisfaction With the BUILD Mobile Application
- ClinicalTrials.gov ID
- NCT05948670
- Acronym / sponsor ID
- W-DISC-001
- Conditions
- Satisfaction, Personal
- Keywords
- Woebot, LLM, Relational agent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Woebot HealthIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 17 Jul 2023 (actual)
- Results
- Posted 7 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study explores user satisfaction with the BUILD mobile application.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| DISC-MVP | Experimental | Device: DISC-MVPParticipants 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-CON | Active comparator | Device: DISC-CONParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Current suicidal ideation with a plan and/or intent or a suicide attempt within the past 12 months
- Previous Woebot use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DISC-MVPDISC-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. | Device | DISC-MVP |
| DISC-CONDISC-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. | Device | DISC-CON |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40408143Campellone 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Campellone, PhD principal investigator
Woebot Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DISC-MVP and DISC-CON in people with Satisfaction, Personal, run by Woebot Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ-8) (time frame: Post-intervention at Week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05948670, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.