SBIR-STTR Award

RCT of Woebot for Substance Use Disorders
Award last edited on: 9/21/2022

Sponsored Program
SBIR
Awarding Agency
NIH : NIDA
Total Award Amount
$1,603,687
Award Phase
2
Solicitation Topic Code
279
Principal Investigator
Athena Robinson

Company Information

Woebot Labs Inc

650 5th Street Suite 303
San Francisco, CA 94107
   (214) 748-3647
   N/A
   www.woebot.io
Location: Single
Congr. District: 12
County: San Francisco

Phase I

Contract Number: 1R44DA048712-01
Start Date: 9/1/2019    Completed: 8/31/2020
Phase I year
2019
Phase I Amount
$218,666
Substance abuse accounts for 5-6% of the US population yet only 20% of individuals with substance use disorders (SUDs) utilize treatment services given the significant treatment access barriers (e.g., stigma; economic, time, and transportation constraints; lack of access to qualified providers; challenges navigating complex treatment systems; low perceived utility). Consumer applications (apps) and automated conversational agents (CAs) may reduce or eliminate common yet significant barriers to traditional SUDs treatment. CAs can deliver a coach or sponsor-like experience and yet do not require human implementation assistance for in-the-moment treatment delivery. Thus, their scale potential is unconstrained and immediate; CAs engage millions of users instantaneously. Being non-human-based also reduces perceived stigma. The conversational, text-based interface increases engagement, a feat non-relational apps have failed to achieve consistently. Woebot, a CA instantaneously available 24 hours per day, 7 days per week, ‘checks in’ with users. Using conversational tones, it encourages mood tracking and delivers general psychoeducation as well as tailored empathy, cognitive behavior therapy (CBT)-based behavior change tools, and behavioral pattern insight. Woebot’s app-based platform and user-centered design philosophy makes it an optimal modality for SUDs treatment delivery; it offers immediate, evidence-based tailored support in the patient’s peak moment of craving. An RCT demonstrated that Woebot had statistically and clinically significant reductions in depression compared to a control group, along with best in class app-engagement rates (mean=12 interactions in 14 days). Woebot does not currently offer a SUDs program, although 63% of current users expressed interest in said content. Woebot’s current, substantial reach as a consumer app, preliminary data indicating its high user engagement plus efficacy to treat a psychological condition, posies it as an ideal platform for a SUDs-focused, tailored, and immediately scalable digital therapeutic. Thus, this application proposes to: (1) develop and pilot an evidence-based, substance abuse content specific for a Woebot-delivered digital therapeutic for individuals with sub- and full syndrome substance use disorders (Woebot-SUDs; phase I); (2) engage with the FDA regarding W-SUDs potential for FDA approval as well as (3) investigate W-SUDs efficacy compared to a SCC in an appropriately powered RCT (phase II).

Public Health Relevance Statement:
Woebot is a commercially available fully automated conversational agent that delivers a self- guided program to support mental health based on cognitive behavior therapy techniques. In line with the objectives of a Fast Track SBIR project, we aim to develop Woebot into an evidence-based intervention for individuals with substance use disorders.

NIH Spending Category:
Behavioral and Social Science; Brain Disorders; Clinical Research; Clinical Trials and Supportive Activities; Drug Abuse (NIDA only); Substance Abuse

Project Terms:
Address; Alcohol or Other Drugs use; base; behavior change; Behavioral; clinically significant; Cognitive Therapy; comparative efficacy; Complex; Control Groups; craving; Data; digital; Economics; Empathy; Evaluation; evidence base; Evidence based intervention; experience; FDA approved; Feedback; Health; Health Services Accessibility; Hour; Human; indexing; Individual; innovation; insight; Institutes; interest; Mediator of activation protein; Mental Depression; Mental Health; Modality; Moods; Participant; Pathway interactions; Patients; Pattern; Persons; Phase; Philosophy; Population; programs; Provider; psychoeducation; psychologic; Public Health; Quality of life; Reporting; Small Business Innovation Research Grant; social stigma; Substance abuse problem; Substance Use Disorder; Syndrome; System; Techniques; technological innovation; Text; Therapeutic; Time; tool; Transportation; treatment services; United States; user centered design; Visit

Phase II

Contract Number: 4R44DA048712-02
Start Date: 9/1/2019    Completed: 8/31/2022
Phase II year
2020
(last award dollars: 2021)
Phase II Amount
$1,385,021

Substance abuse accounts for 5-6% of the US population yet only 20% of individuals with substance use disorders (SUDs) utilize treatment services given the significant treatment access barriers (e.g., stigma; economic, time, and transportation constraints; lack of access to qualified providers; challenges navigating complex treatment systems; low perceived utility). Consumer applications (apps) and automated conversational agents (CAs) may reduce or eliminate common yet significant barriers to traditional SUDs treatment. CAs can deliver a coach or sponsor-like experience and yet do not require human implementation assistance for in-the-moment treatment delivery. Thus, their scale potential is unconstrained and immediate; CAs engage millions of users instantaneously. Being non-human-based also reduces perceived stigma. The conversational, text-based interface increases engagement, a feat non-relational apps have failed to achieve consistently. Woebot, a CA instantaneously available 24 hours per day, 7 days per week, ‘checks in’ with users. Using conversational tones, it encourages mood tracking and delivers general psychoeducation as well as tailored empathy, cognitive behavior therapy (CBT)-based behavior change tools, and behavioral pattern insight. Woebot’s app-based platform and user-centered design philosophy makes it an optimal modality for SUDs treatment delivery; it offers immediate, evidence-based tailored support in the patient’s peak moment of craving. An RCT demonstrated that Woebot had statistically and clinically significant reductions in depression compared to a control group, along with best in class app-engagement rates (mean=12 interactions in 14 days). Woebot does not currently offer a SUDs program, although 63% of current users expressed interest in said content. Woebot’s current, substantial reach as a consumer app, preliminary data indicating its high user engagement plus efficacy to treat a psychological condition, posies it as an ideal platform for a SUDs-focused, tailored, and immediately scalable digital therapeutic. Thus, this application proposes to: (1) develop and pilot an evidence-based, substance abuse content specific for a Woebot-delivered digital therapeutic for individuals with sub- and full syndrome substance use disorders (Woebot-SUDs; phase I); (2) engage with the FDA regarding W-SUDs potential for FDA approval as well as (3) investigate W-SUDs efficacy compared to a SCC in an appropriately powered RCT (phase II).

Public Health Relevance Statement:
Woebot is a commercially available fully automated conversational agent that delivers a self- guided program to support mental health based on cognitive behavior therapy techniques. In line with the objectives of a Fast Track SBIR project, we aim to develop Woebot into an evidence-based intervention for individuals with substance use disorders.

Project Terms:
Address; Alcohol or Other Drugs use; base; behavior change; Behavioral; clinically significant; Cognitive Therapy; comparative efficacy; Complex; Control Groups; craving; Data; digital; Economics; Empathy; Evaluation; evidence base; Evidence based intervention; experience; FDA approved; Feedback; Health; Health Services Accessibility; Hour; Human; indexing; Individual; innovation; insight; Institutes; interest; Mediator of activation protein; Mental Depression; Mental Health; Modality; Moods; Participant; Pathway interactions; Patients; Pattern; Persons; Phase; Philosophy; Population; programs; Provider; psychoeducation; psychologic; Public Health; Quality of life; Reporting; Small Business Innovation Research Grant; social stigma; Substance abuse problem; Substance Use Disorder; Syndrome; System; Techniques; technological innovation; Text; Therapeutic; Time; tool; Transportation; treatment services; United States; user centered design; Visit