The Anchor Study: Digitally Delivered Intervention for Reducing Problematic Substance Use

NCT ID: NCT04925570

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-14
• Study Completion Date: 2023-08-17

Brief Summary

This study aims to validate W-SUDs as a digitally-delivered substance use disorder program through a fully-powered randomized control trial that will test the comparative efficacy of the mobile-app based substance use disorder program (W-SUDs) to reduce substance use relative to a psychoeducation control condition, which has no cognitive behavioral therapy and the content is not delivered through a conversational user interface.

Detailed Description

Phase II will evaluate the efficacy of W-SUDs in a large scale RCT relative to a psychoeducation control condition. Primary outcomes will be measures of the quantity and frequency of substance use including number of substance use occasions, heavy drinking days (if applicable) and percent reduction in substance use occasions. Additionally, Phase II will evaluate whether W-SUDs results in a greater reduction in substance-related problems compared to a psychoeducation control group and explore if engagement with W-SUDs, relative to psychoeducation control,

1. improves symptoms of depression and anxiety;

2. improves work productivity (i.e. reduce presenteeism/absenteeism);

3. reduces cravings;

4. improves situational confidence to resist substance use.

Conditions

Alcohol Use Disorder (AUD); Substance Use Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

W-SUDs

Woebot (W-SUDs), a Conversational Agent (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 Substance Use Disorders (SUD) treatment delivery. It offers immediate, evidence-based tailored support in the patient's peak moment of craving.

Group Type: EXPERIMENTAL

W-SUDs

Intervention Type: DEVICE

Woebot (W-SUDs) is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.

Digitally-delivered Psychoeducation

Psychoeducation delivers weekly fact sheets that include information on:

1. Alcohol-specific topics;

2. Drug-specific topics;

3. General addiction topics;

4. Statistics relating to alcohol and substance use.

Group Type: OTHER

Digitally-delivered Psychoeducation

Intervention Type: OTHER

A form of psychoeducation for those seeking treatment for their alcohol and/or substance use concern. Psychoeducation is commonly provided for those with substance use. Psychoeducation in substance use is intended to increase the users' knowledge of their substances of use, and effects on the body, behaviors, and consequences. The recipient of psychoeducation is expected to increase their own awareness of their substance use and ideally incorporate this newfound knowledge when making changes to their substance use. The information provided in this group are from factsheets found on NIAAA, NIDA, and CDC web pages.

Interventions

W-SUDs

Woebot (W-SUDs) is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.

Intervention Type: DEVICE

Digitally-delivered Psychoeducation

A form of psychoeducation for those seeking treatment for their alcohol and/or substance use concern. Psychoeducation is commonly provided for those with substance use. Psychoeducation in substance use is intended to increase the users' knowledge of their substances of use, and effects on the body, behaviors, and consequences. The recipient of psychoeducation is expected to increase their own awareness of their substance use and ideally incorporate this newfound knowledge when making changes to their substance use. The information provided in this group are from factsheets found on NIAAA, NIDA, and CDC web pages.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Have a smartphone

2. Endorse a substance use concern

3. Be between 18 and 65 years of age

4. Be available and committed to engage with the Woebot app

5. Be literate in English. (This is required for inclusion because all materials will be in English).

Exclusion Criteria

1. Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)

2. Suicide attempt within the past year (12 months)

3. Symptoms of severe drug/alcohol history: History of delirium tremens; Experiencing hypertension, drenching sweats, seizures or confusion after stopping alcohol or drugs; Liver trouble (cirrhosis or hepatitis); Convulsions or GI bleeding due to drug/alcohol use

4. Opioid overdose within the past year (12 months)

5. Opioid misuse without medication-assisted treatment

6. Not residing in the U.S.

7. Previous Woebot use

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

Woebot Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judith Prochaska, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

References

Moore JB, Chieng A, Pirner MC, Pajarito S, Vogel EA, Bowdring MA, Bullard L, Robinson A, Prochaska JJ. Mitigating fraud in a fully decentralized clinical trial of a digital health intervention. Ann Behav Med. 2025 Jan 4;59(1):kaaf047. doi: 10.1093/abm/kaaf047.

Reference Type: DERIVED

PMID: 40548528 (View on PubMed)

Prochaska JJ, Vogel EA, Chieng A, Baiocchi M, Pajarito S, Pirner M, Darcy A, Robinson A. A relational agent for treating substance use in adults: Protocol for a randomized controlled trial with a psychoeducational comparator. Contemp Clin Trials. 2023 Apr;127:107125. doi: 10.1016/j.cct.2023.107125. Epub 2023 Feb 20.

Reference Type: DERIVED

PMID: 36813084 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

58725

Identifier Type: -

Identifier Source: org_study_id