Satisfaction, Personal
Conditions
Keywords
Woebot, LLM, Relational agent
Brief summary
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.
Interventions
DEVICEDISC-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.
DEVICEDISC-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.
Sponsors
Woebot Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Intervention model description
1:1 randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 81 |
| 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. | 79 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 6 | 8 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | DISC-MVP | Total | DISC-CON |
|---|---|---|---|
| Age, Continuous | 41.99 years STANDARD_DEVIATION 12.85 | 43.82 years STANDARD_DEVIATION 14.08 | 45.70 years STANDARD_DEVIATION 15.09 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 17 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 72 Participants | 143 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 47 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 5 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) White | 47 Participants | 94 Participants | 47 Participants |
| Region of Enrollment United States | 81 participants | 160 participants | 79 participants |
| Sex: Female, Male Female | 57 Participants | 117 Participants | 60 Participants |
| Sex: Female, Male Male | 24 Participants | 43 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 87 | 0 / 88 |
| other Total, other adverse events | 1 / 87 | 7 / 88 |
| serious Total, serious adverse events | 0 / 87 | 0 / 88 |
Outcome results
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.
Time frame: Post-intervention at Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DISC-MVP | User Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ-8) | 23.49 score on a scale | Standard Deviation 6.3 |
| DISC-CON | User Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ-8) | 23.97 score on a scale | Standard Deviation 5.95 |
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.
Time frame: Post-intervention at Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DISC-MVP | User Satisfaction Amongst a Sub-sample of Adults With at Least Mild Symptoms of Depression and/or Anxiety. | 22.95 score on a scale | Standard Deviation 6.49 |
| DISC-CON | User Satisfaction Amongst a Sub-sample of Adults With at Least Mild Symptoms of Depression and/or Anxiety. | 23.68 score on a scale | Standard Deviation 6.03 |