Potency and Precision Investigation

Depression, Anxiety Clinical Trial

— PAPI  

Official title:

An Exploratory Open-Label Potency and Precision Investigation of a Relational Agent Intervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06240091
• Other study ID #: W-DISC-002
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 13, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: April 2024
• Source: Woebot Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 203
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Woebot Investigational Site	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Woebot Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 week and Post-treatment at 4 weeks