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Alcohol Use Disorder (AUD)Phase 2NCT04925570

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

A Phase 2 study testing W-SUDs and Digitally-delivered Psychoeducation in people with Alcohol Use Disorder (AUD) and Substance Use Disorders, run by Woebot Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
W-SUDs and Digitally-delivered Psychoeducation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
258 participants
Where
1 siteUnited States
Study dates
14 Nov 2022to 17 Aug 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a smartphone
  • Endorse a substance use concern
  • Be between 18 and 65 years of age
  • Be available and committed to engage with the Woebot app
  • Be literate in English. (This is required for inclusion because all materials will be in English).

Who cannot join

  • Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
  • Suicide attempt within the past year (12 months)
  • 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
  • Opioid overdose within the past year (12 months)
  • Opioid misuse without medication-assisted treatment
  • Not residing in the U.S.
  • Previous Woebot use

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Stanford University

    Palo Alto, California, 94304

Other trials in United States

About this study

Official title: Woebot for Substance Use Disorders Phase 2 RCT: Digitally Delivered Intervention for Reducing Problematic Substance Use

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.

Read the 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.
Being tested
W-SUDs, Digitally-delivered Psychoeducation
Keywords
Alcohol Use Disorder, Substance Use Disorder, AUD, SUD, AUD Treatment, SUD Treatment, Smartphone Application, Digital Therapeutic, Alcohol Use Disorder Treatment, Substance Use Disorder Treatment
Medical subject headings
Alcoholism, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • W-SUDsDevice

    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 PsychoeducationOther

    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.

Study groups in NCT04925570
Study groupRoleWhat they receive
W-SUDsExperimentalWoebot (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.
Receives: Device: W-SUDs
Digitally-delivered PsychoeducationOtherPsychoeducation 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.
Receives: Other: Digitally-delivered Psychoeducation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Number of Substance Use Occasions

    Change in number of substance use occasions in the past 30 days

    Measured: Change from Baseline to Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks

Secondary outcomes (15)
  1. Drug Abuse Screening Test (DAST-10)

    Measure of drug abuse related consequences. The DAST-10 is a brief, 10-item self-report measure that assesses consequences related to drug abuse, excluding alcohol and tobacco. The range is 0-10, where higher scores indicate greater severity. Adapted from past 12 months to past 30 days.

    Measured: Change from Baseline to Post-treatment at 8 weeks

  2. Working Alliance Inventory (WAI-SR)

    Measure of working alliance. A measure of therapeutic alliance 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. Task, goal, and bond subscales scores range from 5-20, with higher scores indicating greater alliance. The present study utilized the validated 12-item Short-Revised version (WAI-SR) with minor changes to language, replacing "therapist" with "Woebot".

    Measured: Post-treatment at 8 weeks

  3. Stanford Presenteeism Scale (SPS-6)

    Measure of the effects of substance use on productivity. The SPS-6 is a 6-item self-report measure used to assess perceptions of the effects of substance use on past 2-week work productivity. Response options range from strongly disagree (1) to strongly agree (5). Total scores range from 6 to 30, where higher scores indicate higher presenteeism.

    Measured: Change from Baseline to Post-treatment at 8 weeks

  4. Thoughts About Abstinence (TAA): Desire to Quit, Expected Success at Quitting, Expected Difficulty of Quitting Items

    Modified for alcohol and substances. 4-item questionnaire assessing desire to quit, expected success at quitting, expected difficulty of quitting, and goal. Each of the first three items is rated on a scale of 1 to 10 where 1 is the lowest (desire, expectation, confidence) and 10 is the highest (desire, expectation, confidence). The scores are not combined. Goal for use is a single response selection item, with the option to provide a text explanation if none of the goals align. Goal data are reported as a separate outcome measure.

    Measured: Change from Baseline to Post-treatment at 8 weeks

  5. Thoughts About Abstinence (TAA): Goal Item

    Modified for alcohol and substances. 4-item questionnaire assessing desire to quit, expected success at quitting, expected difficulty of quitting, confidence in ability to quit, and goal. Each of the first three items is rated on a scale of 1 to 10 where 1 is the lowest (desire, expectation, confidence) and 10 is the highest (desire, expectation, confidence). The scores are not combined. Goal for use is a single response selection item, with the option to provide a text explanation if none of the goals align. Desire to Quit, Expected Success at Quitting, Expected Difficulty of Quitting item data are reported as a separate outcome measure.

    Measured: Baseline and Post-treatment at 8 weeks

  6. Usage Rating Profile - Intervention (URPI)-Acceptability

    Measure of acceptability. A 9-item subscale that inquires about intervention acceptability. For the purposes of this study, an adapted 6-item version of the subscale was utilized. Items are rated on a 6-point Likert scale (1 = "strongly disagree" to 6 = "strongly agree"). Total acceptability scores range from 6-36, with higher scores indicating greater intervention acceptability.

    Measured: Post-treatment at 8 weeks

  7. Usage Rating Profile - Intervention (URPI)-Feasibility

    Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Items are rated on a 6-point Likert scale (1 = "slightly disagree" to 6 = "strongly agree"). Total feasibility scores range from 6-36, with higher scores indicating greater intervention feasibility.

    Measured: Post-treatment at 8 weeks

  8. Client Satisfaction Questionnaire (CSQ-8)

    Measure of satisfaction. An 8-item measure used to assess client's satisfaction with treatment on a 4-point scale. Example questions include, "How would you rate the quality of service you received"? and "Did you get the kind of service you wanted?" Total sums range from 8-32, with high scores indicating greater satisfaction with the W-SUDs mobile application.

    Measured: Post-treatment at 8 weeks

  9. Short Inventory of Problems- Alcohol and Drugs (SIP-AD)

    The SIP-AD assesses substance use problems in the past 30 days. The scored variables, total scores and 15-item mean, summarize consequences of alcohol and drug use. Scores range from 0-45, where greater scores indicate greater substance use problems.

    Measured: Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks

  10. Patient Health Questionnaire (PHQ-8)

    Measure of depression severity. An 8-item abbreviated version of the PHQ-9 used to assess mood symptoms. The PHQ-8 excludes an item assessing suicidality. Items are rated on a 4-point Likert scale (0 = "not at all" to 3 = "nearly every day"). Total score between 0-24, with higher scores indicating greater severity of depression symptoms.

    Measured: Change from Baseline to Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks

  11. Generalized Anxiety Disorder (GAD-7)

    Measure of anxiety severity. A 7-item self-report measure used to assess the frequency and severity of anxious thoughts and behaviors over the past 2 weeks. Items are rated on a 4-point Likert scale (0 = "not at all" to 3 = "nearly every day").Total scores range from 0-21, where higher scores indicate greater severity of anxiety symptoms.

    Measured: Change from Baseline to Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks

  12. Brief Situational Confidence Questionnaire (BSCQ)

    Measure of self-confidence. The 8-item BSCQ is a state dependent measure that assesses self-confidence to resist the urge to drink heavily or use drugs in a variety of situations. Each of the 8 scale situations consists of a 100-mm line, anchored by 0% ("not at all confident") and 100% ("totally confident") where clients are asked to indicate confidence on a scale from 0% to 100%. Higher scores are associated with greater confidence.

    Measured: Change from Baseline to Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks

  13. Craving Ratings

    Self-reported ratings of craving intensity. Craving is assessed with a single question, "In the past 7 days, how much were you bothered by cravings or urges to drink alcohol or use drugs?". The question is rated on a scale of 0 to 4 where 0 = not at all, 1 = a little bit, 2 = moderately, 3 = quite a bit, and 4 = extremely. Greater scores indicate a more intense urge to use.

    Measured: Change from Baseline to Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks

  14. Past Month Number of Binge Days

    Assessed with the Quick Drinking Screen (QDS), a measure of alcohol consumption. The QDS is a brief self-report measure used to assess average alcohol consumption over a specified time period (in the present study it was the past 30 days). The QDS collects drinking data for three variables including number of days drinking, number of standard drinks per drinking day, and number of binge/risky drinking days. Binge/risky drinking days is defined as days when they have had 5 or more standard drinks (for men) or 4 or more standard drinks (for women).

    Measured: Change from Baseline to Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks

  15. Past Month Average Standard Drinks in a Week

    Assessed with the Quick Drinking Screen (QDS), a measure of alcohol consumption. The QDS is a brief self-report measure used to assess average alcohol consumption over a specified time period (in the present study it was the past 30 days). The QDS collects drinking data for three variables including number of days drinking, number of standard drinks per drinking day, and number of binge/risky drinking days. Binge/risky drinking days is defined as days when they have had 5 or more standard drinks (for men) or 4 or more standard drinks (for women). Number of standard drinks per week is calculated by multiplying number of standard drinks per day in the past month and number of binge days per month.

    Measured: Change from Baseline to Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2021
  2. Study start14 Nov 2022
  3. Primary completion17 Aug 2023
  4. Study completion17 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
258 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04925570
Sponsor's protocol ID
58725
Status last verified
Oct 2024
First submitted
25 May 2021
Last updated
24 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Prochaska JJ, Wang M, Chieng A, Moore J, Vogel EA, Baiocchi M, Pajarito S, Pirner MC, Bullard L, Darcy A, Robinson A. A relational agent for treating substance use in adults: A randomized controlled trial with a psychoeducational comparator. J Subst Use Addict Treat. 2026 Sep;188:209993. doi: 10.1016/j.josat.2026.209993. Epub 2026 Apr 24.

    PubMed 42035882
  • 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.

    PubMed 40548528
  • 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.

    PubMed 36813084

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing W-SUDs and Digitally-delivered Psychoeducation in people with Alcohol Use Disorder (AUD) and Substance Use Disorders, run by Woebot Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Number of Substance Use Occasions (time frame: Change from Baseline to Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04925570, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.

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