Clinical trial NCT06240091: Potency and Precision Investigation
Official title: An Exploratory Open-Label Potency and Precision Investigation of a Relational Agent Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Keywords: Woebot
Relational agent
Digital mental health intervention
Chatbot
Conversational agent
Natural language processing
Artificial intelligence
Lead sponsor: Woebot Health
Sponsor class: INDUSTRY
First posted: 2024-02-02
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Working Alliance Inventory-Short Revised (WAI-SR), Total Scale
timeFrame: 1 week and Post-treatment at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Woebot Investigational Site
state: California
Study officials:
affiliation: Woebot Health
name: Tim Campellone, PhD
role: PRINCIPAL_INVESTIGATOR
References: