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NCT06240091 | COMPLETED | Depression, Anxiety

Potency and Precision Investigation
Sponsor:

Woebot Health

Brief Summary:

The overarching goal of this study is to establish initial proof of mechanism for precision interventions in an adult population.

Condition or disease

Depression, Anxiety

Intervention/treatment

DISC-MA

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 203 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : An Exploratory Open-Label Potency and Precision Investigation of a Relational Agent Intervention
Actual Study Start Date : 2024-03-13
Estimated Primary Completion Date : 2024-05-09
Estimated Study Completion Date : 2024-05-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Potency and Precision Investigation

Location Details

NCT06240091

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

Woebot Investigational Site

San Francisco, California, United States, 94105