Trial Outcomes & Findings for Potency and Precision Investigation (NCT NCT06240091)
NCT ID: NCT06240091
Last Updated: 2025-02-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
203 participants
Primary outcome timeframe
1 week and Post-treatment at 4 weeks
Results posted on
2025-02-19
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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203
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Overall Study
COMPLETED
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201
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Potency and Precision Investigation
Baseline characteristics by cohort
| Measure |
DISC-MA
n=203 Participants
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.
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Race/Ethnicity, Customized
Non-Hispanic White
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114 Participants
n=5 Participants
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Region of Enrollment
United States
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203 participants
n=5 Participants
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Age, Continuous
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43.22 years
STANDARD_DEVIATION 13.73 • n=5 Participants
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Sex: Female, Male
Female
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154 Participants
n=5 Participants
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Sex: Female, Male
Male
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49 Participants
n=5 Participants
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Race/Ethnicity, Customized
Hispanic or Latinx
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21 Participants
n=5 Participants
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Race/Ethnicity, Customized
Non-Hispanic American Indian or Alaskan Native
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Non-Hispanic Asian
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16 Participants
n=5 Participants
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Race/Ethnicity, Customized
Non-Hispanic Black or African American
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38 Participants
n=5 Participants
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Race/Ethnicity, Customized
Non-Hispanic Middle Eastern or North African
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Non-Hispanic more than one race
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11 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 1 week and Post-treatment at 4 weeksPopulation: Data missing
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.
Outcome measures
| Measure |
DISC-MA
n=201 Participants
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.
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Working Alliance Inventory-Short Revised (WAI-SR), Total Scale
Week 1 Goal
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3.63 score on a scale
Standard Deviation 0.98
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Working Alliance Inventory-Short Revised (WAI-SR), Total Scale
Week 1 Task
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3.25 score on a scale
Standard Deviation 0.88
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Working Alliance Inventory-Short Revised (WAI-SR), Total Scale
Week 1 Bond
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3.95 score on a scale
Standard Deviation 0.96
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Working Alliance Inventory-Short Revised (WAI-SR), Total Scale
Week 1 Total
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3.61 score on a scale
Standard Deviation 0.83
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Working Alliance Inventory-Short Revised (WAI-SR), Total Scale
Week 4 Goal
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3.72 score on a scale
Standard Deviation 0.99
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Working Alliance Inventory-Short Revised (WAI-SR), Total Scale
Week 4 Task
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3.40 score on a scale
Standard Deviation 0.92
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Working Alliance Inventory-Short Revised (WAI-SR), Total Scale
Week 4 Bond
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4.02 score on a scale
Standard Deviation 0.98
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Working Alliance Inventory-Short Revised (WAI-SR), Total Scale
Week 4 Total
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3.71 score on a scale
Standard Deviation 0.87
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Adverse Events
DISC-MA
Serious events: 2 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DISC-MA
n=203 participants at risk
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.
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Psychiatric disorders
Eating disorders and disturbances
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0.49%
1/203 • Number of events 1 • 4 weeks
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Psychiatric disorders
Active suicidal ideation
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0.49%
1/203 • Number of events 1 • 4 weeks
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Other adverse events
| Measure |
DISC-MA
n=203 participants at risk
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.
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|---|---|
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Psychiatric disorders
Psychiatric disorders
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12.3%
25/203 • Number of events 37 • 4 weeks
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General disorders
General disorders
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2.0%
4/203 • Number of events 4 • 4 weeks
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Surgical and medical procedures
Surgical and medical procedures
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0.49%
1/203 • Number of events 1 • 4 weeks
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Reproductive system and breast disorders
Prostatic disorder
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0.99%
2/203 • Number of events 2 • 4 weeks
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Nervous system disorders
Nervous system disorders
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2.0%
4/203 • Number of events 4 • 4 weeks
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Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
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3.0%
6/203 • Number of events 6 • 4 weeks
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Gastrointestinal disorders
Gastrointestinal disorder
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0.49%
1/203 • Number of events 1 • 4 weeks
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Infections and infestations
Infections and infestations
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1.5%
3/203 • Number of events 4 • 4 weeks
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Investigations
Investigations
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0.99%
2/203 • Number of events 2 • 4 weeks
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Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
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0.99%
2/203 • Number of events 2 • 4 weeks
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Eye disorders
Glaucoma
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0.49%
1/203 • Number of events 1 • 4 weeks
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Congenital, familial and genetic disorders
Chiari malformation
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0.49%
1/203 • Number of events 1 • 4 weeks
|
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Cardiac disorders
Chest pain
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0.49%
1/203 • Number of events 1 • 4 weeks
|
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Metabolism and nutrition disorders
Pre-diabetic
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0.49%
1/203 • Number of events 1 • 4 weeks
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumor
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0.49%
1/203 • Number of events 1 • 4 weeks
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Skin and subcutaneous tissue disorders
Surgical wound
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0.49%
1/203 • Number of events 1 • 4 weeks
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place