Depression, Anxiety
Conditions
Keywords
Woebot, Relational agent, Digital mental health intervention, Chatbot, Conversational agent, Natural language processing, Artificial intelligence
Brief summary
The overarching goal of this study is to establish initial proof of mechanism for precision interventions in an adult population.
Detailed description
This exploratory single-arm trial will provide initial learning on the current implementation of precision interventions and generate data and hypotheses to inform the exploration of future interventions by identifying mechanisms and moments in the user journey to target. The DISC-MA app uses a relational agent (Woebot) to engage users in conversations. Eligible participants will be assigned to use DISC-MA, in which Woebot selects from a list of responses based on natural language processing. Participants will receive instructions on downloading and using the DISC-MA app in order to access the intervention. Participants will use the app as instructed and will complete assessments for the primary endpoint as Week 4 (EOT) with additional measures being collected as Baseline, Week 1, and Week 2. Results from this study will provide data on baseline participant clinical and psychological characteristics and their engagement with DISC-MA, and associations between the two.
Interventions
DEVICEDISC-MA
DISC-MA is a digital program that utilizes elements from validated psychotherapies (e.g., cognitive behavioral therapy), with a relational agent (Woebot) that engages users in conversations with responses that are selected from a list based on natural language processing.
Sponsors
Woebot Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Must be 18-75 years of age 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 4-week duration 4. Must be able to read and write in English 5. Must have primary residence in the United States 6. Must have mild or greater symptoms of depression and/or anxiety at Screening/Baseline, indicated by a score \> 4 on the Patient Health Questionnaire (PHQ-8) and/or Generalized Anxiety Disorder (GAD-7)
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 3. Involuntary inpatient psychiatric hospitalization any time within the past 30 days 4. Lifetime diagnosis of bipolar disorder 5. Lifetime diagnosis of a psychotic disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Working Alliance Inventory-Short Revised (WAI-SR), Total Scale | 1 week and Post-treatment at 4 weeks | Measure of working alliance. A 12-item measure that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy, and (c) development of an affective bond. For the purposes of the study, the word therapist was replaced with Woebot. Total mean scores range from 1-5, with higher scores indicating greater alliance between the participant and Woebot. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DISC-MA All participants will be asked to download and use the DISC-MA study application. They will have access to the app throughout the 4 week study.
DISC-MA: DISC-MA is a digital program that utilizes elements from validated psychotherapies (e.g., cognitive behavioral therapy), with a relational agent (Woebot) that engages users in conversations with responses that are selected from a list based on natural language processing. | 203 |
| Total | 203 |
Baseline characteristics
| Characteristic | DISC-MA |
|---|---|
| Age, Continuous | 43.22 years STANDARD_DEVIATION 13.73 |
| Race/Ethnicity, Customized Hispanic or Latinx | 21 Participants |
| Race/Ethnicity, Customized Non-Hispanic American Indian or Alaskan Native | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic Asian | 16 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black or African American | 38 Participants |
| Race/Ethnicity, Customized Non-Hispanic Middle Eastern or North African | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic more than one race | 11 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 114 Participants |
| Region of Enrollment United States | 203 participants |
| Sex: Female, Male Female | 154 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 203 |
| other Total, other adverse events | 56 / 203 |
| serious Total, serious adverse events | 2 / 203 |
Outcome results
Primary
Working Alliance Inventory-Short Revised (WAI-SR), Total Scale
Measure of working alliance. A 12-item measure that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy, and (c) development of an affective bond. For the purposes of the study, the word therapist was replaced with Woebot. Total mean scores range from 1-5, with higher scores indicating greater alliance between the participant and Woebot.
Time frame: 1 week and Post-treatment at 4 weeks
Population: Data missing
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DISC-MA | Working Alliance Inventory-Short Revised (WAI-SR), Total Scale | Week 1 Goal | 3.63 score on a scale | Standard Deviation 0.98 |
| DISC-MA | Working Alliance Inventory-Short Revised (WAI-SR), Total Scale | Week 1 Task | 3.25 score on a scale | Standard Deviation 0.88 |
| DISC-MA | Working Alliance Inventory-Short Revised (WAI-SR), Total Scale | Week 1 Bond | 3.95 score on a scale | Standard Deviation 0.96 |
| DISC-MA | Working Alliance Inventory-Short Revised (WAI-SR), Total Scale | Week 1 Total | 3.61 score on a scale | Standard Deviation 0.83 |
| DISC-MA | Working Alliance Inventory-Short Revised (WAI-SR), Total Scale | Week 4 Goal | 3.72 score on a scale | Standard Deviation 0.99 |
| DISC-MA | Working Alliance Inventory-Short Revised (WAI-SR), Total Scale | Week 4 Task | 3.40 score on a scale | Standard Deviation 0.92 |
| DISC-MA | Working Alliance Inventory-Short Revised (WAI-SR), Total Scale | Week 4 Bond | 4.02 score on a scale | Standard Deviation 0.98 |
| DISC-MA | Working Alliance Inventory-Short Revised (WAI-SR), Total Scale | Week 4 Total | 3.71 score on a scale | Standard Deviation 0.87 |