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OpenTrials
Completed

NCT Number: NCT06240091

Potency and Precision Investigation

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

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Key information

Conditions

Depression, Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Woebot Investigational Site

San Francisco, California, 94105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be 18-75 years of age
  • 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
  • Must be available and committed to engage with the program and complete assessments for a 4-week duration
  • Must be able to read and write in English
  • Must have primary residence in the United States
  • 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

  • Current suicidal ideation with a plan and/or intent or a suicide attempt within the past 12 months
  • Previous Woebot use
  • Involuntary inpatient psychiatric hospitalization any time within the past 30 days
  • Lifetime diagnosis of bipolar disorder
  • Lifetime diagnosis of a psychotic disorder

Treatment and study plan

DISC-MA

Device

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.

Primary outcomes

  1. Working Alliance Inventory-Short Revised (WAI-SR), Total Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Woebot Health

Industry

Registry information

Official study title

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

Acronym: PAPI

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 2, 2024
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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