CClinicalTrials.gg
CompletedNCT04925570Updated Oct 24, 2024Results posted

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

A Phase 2 interventional study of W-SUDs and Digitally-delivered Psychoeducation in Alcohol Use Disorder (AUD) and Substance Use Disorders, sponsored by Woebot Health. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-24.

Sponsored by Woebot Health · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
258
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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.
02

Conditions studied

  • Alcohol Use Disorder (AUD)
  • Substance Use Disorders

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
03

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's enrollment of 258 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

Woebot Health is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
258 participants (actual)

Study arms

  • Experimental
    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.

    Device: W-SUDs

  • Other
    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.

    Other: Digitally-delivered Psychoeducation

Interventions

  • DeviceW-SUDs

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

  • OtherDigitally-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.

06

What researchers measure

Primary outcomes

  1. Change in Number of Substance Use Occasions

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

    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

Secondary outcomes

  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.

    Time frame: 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".

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    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

  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.

    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

  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.

    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

  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.

    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

  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.

    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

  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).

    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

  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.

    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

07

Results

Posted Oct 24, 2024

Participant flow

Participant flow — Overall Study
MilestoneW-SUDsDigitally-delivered Psychoeducation
Started131127
Completed10795
Not completed2432
Withdrew: Protocol violation2430
Withdrew: Withdrawal by subject02

Outcome measures

PrimaryChange in Number of Substance Use Occasions

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

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
Reported as:
Mean · occasions
Change in Number of Substance Use Occasions
occasionsW-SUDsDigitally-delivered Psychoeducation
Week 4-11.3 ± 15.9-11.2 ± 12.9
Week 8-13.6 ± 15.4-12.9 ± 15.3
Week 12-15.7 ± 18-15.4 ± 16.6
SecondaryDrug 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.

Time frame:
Change from Baseline to Post-treatment at 8 weeks
Reported as:
Mean · score on a scale
Drug Abuse Screening Test (DAST-10)
score on a scaleW-SUDsDigitally-delivered Psychoeducation
Drug Abuse Screening Test (DAST-10)-1.21 ± 2.33-1.95 ± 1.99
SecondaryWorking 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".

Time frame:
Post-treatment at 8 weeks
Reported as:
Mean · score on a scale
Working Alliance Inventory (WAI-SR)
score on a scaleW-SUDs
Goal14.8 ± 4.4
Task14.4 ± 4.5
Bond15.2 ± 4.5
SecondaryStanford 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.

Time frame:
Change from Baseline to Post-treatment at 8 weeks
Reported as:
Mean · score on a scale
Stanford Presenteeism Scale (SPS-6)
score on a scaleW-SUDsDigitally-delivered Psychoeducation
Stanford Presenteeism Scale (SPS-6)-5.42 ± 7.2-4.12 ± 6.97
SecondaryThoughts 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.

Time frame:
Change from Baseline to Post-treatment at 8 weeks
Reported as:
Mean · score on a scale
Thoughts About Abstinence (TAA): Desire to Quit, Expected Success at Quitting, Expected Difficulty of Quitting Items
score on a scaleW-SUDsDigitally-delivered Psychoeducation
Desire to quit0.21 ± 2.330.12 ± 2.71
Expected success at quitting0.42 ± 2.370.53 ± 2.72
Expected difficulty of quitting-0.64 ± 2.44-0.28 ± 2.91
SecondaryThoughts 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.

Time frame:
Baseline and Post-treatment at 8 weeks
Reported as:
Number · participants
Thoughts About Abstinence (TAA): Goal Item
participantsW-SUDsDigitally-delivered Psychoeducation
No goal (Baseline)1012
Controlled use (Baseline)2522
Short-term abstinence (Baseline)149
Occasional use when there is urge (Baseline)1719
Quit, but might slip (Baseline)1311
Quit forever (Baseline)2518
Other (Baseline)34
No goal (8 weeks)1612
Controlled use (8 weeks)1928
Short-term abstinence, then decide about continued use (8 weeks)156
Occasional use when there is urge (8 weeks)86
Quit, but might slip (8 weeks)1411
Quit forever (8 weeks)2521
Other (8 weeks)35
Prefer not to answer (8 weeks)01
SecondaryUsage 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.

Time frame:
Post-treatment at 8 weeks
Reported as:
Mean · score on a scale
Usage Rating Profile - Intervention (URPI)-Acceptability
score on a scaleW-SUDsDigitally-delivered Psychoeducation
Usage Rating Profile - Intervention (URPI)-Acceptability30.1 ± 5.630.3 ± 5.8
SecondaryUsage 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.

Time frame:
Post-treatment at 8 weeks
Reported as:
Mean · score on a scale
Usage Rating Profile - Intervention (URPI)-Feasibility
score on a scaleW-SUDsDigitally-delivered Psychoeducation
Usage Rating Profile - Intervention (URPI)-Feasibility28.0 ± 3.529.8 ± 2.6
SecondaryClient 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.

Time frame:
Post-treatment at 8 weeks
Reported as:
Mean · score on a scale
Client Satisfaction Questionnaire (CSQ-8)
score on a scaleW-SUDsDigitally-delivered Psychoeducation
Client Satisfaction Questionnaire (CSQ-8)26.9 ± 5.228.1 ± 4.5
SecondaryShort 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.

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
Reported as:
Mean · score on a scale
Short Inventory of Problems- Alcohol and Drugs (SIP-AD)
score on a scaleW-SUDsDigitally-delivered Psychoeducation
Mid-treatment at 4 weeks-8.02 ± 9.35-7.39 ± 9.95
Post-treatment at 8 weeks-9.02 ± 11.6-9.24 ± 10.2
Follow-up at 12 weeks-11.5 ± 11.5-10.9 ± 11.5
SecondaryPatient 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.

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
Reported as:
Mean · score on a scale
Patient Health Questionnaire (PHQ-8)
score on a scaleW-SUDsDigitally-delivered Psychoeducation
Mid-treatment at 4 weeks-1.84 ± 4.24-1.44 ± 4.45
Post-treatment at 8 weeks-2.82 ± 4.65-2.05 ± 5.95
Follow-up at 12 weeks-2.83 ± 4.79-2.87 ± 6.3
SecondaryGeneralized 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.

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
Reported as:
Mean · score on a scale
Generalized Anxiety Disorder (GAD-7)
score on a scaleW-SUDsDigitally-delivered Psychoeducation
Mid-treatment at 4 weeks-1.31 ± 4.05-1.56 ± 3.97
Post-treatment at 8 weeks-1.88 ± 4.77-1.72 ± 4.91
Follow-up at 12 weeks-2.09 ± 4.67-2.57 ± 5.08
SecondaryBrief 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.

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
Reported as:
Mean · score on a scale
Brief Situational Confidence Questionnaire (BSCQ)
score on a scaleW-SUDsDigitally-delivered Psychoeducation
Mid-treatment at 4 weeks7.3 ± 21.410.4 ± 23.2
Post-treatment at 8 weeks6.77 ± 20.411.6 ± 20.3
Follow-up at 12 weeks11.6 ± 21.815.6 ± 26.1
SecondaryCraving 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.

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
Reported as:
Mean · score on a scale
Craving Ratings
score on a scaleW-SUDsDigitally-delivered Psychoeducation
Mid-treatment at 4 weeks-0.418 ± 0.994-0.56 ± 1.14
Post-treatment at 8 weeks-0.66 ± 1.18-0.722 ± 1.2
Follow-up at 12 weeks-0.816 ± 1.15-0.892 ± 1.4
SecondaryPast 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).

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
Reported as:
Mean · days
Past Month Number of Binge Days
daysW-SUDsDigitally-delivered Psychoeducation
Mid-treatment at 4 weeks-4.26 ± 6.88-2.45 ± 5.66
Post-treatment at 8 weeks-4.09 ± 6.35-2.51 ± 6.02
Follow-up at 12 weeks-5.43 ± 7.21-3.14 ± 7.75
SecondaryPast 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.

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
Reported as:
Mean · Drinks per week
Past Month Average Standard Drinks in a Week
Drinks per weekW-SUDsDigitally-delivered Psychoeducation
Mid-treatment at 4 weeks-7.62 ± 14.9-6.92 ± 12.4
Post-treatment at 8 weeks-8.67 ± 14.7-8.18 ± 11.5
Follow-up at 12 weeks-11.1 ± 15.7-9.43 ± 13.9

Adverse events

Collected over Serious adverse events were assessed at post-treatment and follow-up at 8-weeks and 12-weeks from baseline, respectively.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
W-SUDs0/107 (0%)0/107 (0%)0/107 (0%)
Digitally-delivered Psychoeducation0/95 (0%)0/95 (0%)0/95 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)W-SUDsDigitally-delivered PsychoeducationTotal
Mean38.2 ± 11.438.6 ± 9.238.3 ± 10.4
Sex: Female, Male
Sex: Female, Male(Participants)W-SUDsDigitally-delivered PsychoeducationTotal
Female5058108
Male573794
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)W-SUDsDigitally-delivered PsychoeducationTotal
Hispanic or Latino121123
Not Hispanic or Latino9484178
Unknown or Not Reported101
Race (NIH/OMB)
Race (NIH/OMB)(Participants)W-SUDsDigitally-delivered PsychoeducationTotal
American Indian or Alaska Native213
Asian134
Native Hawaiian or Other Pacific Islander000
Black or African American172845
White8658144
More than one race033
Unknown or Not Reported123
Region of Enrollment
Region of Enrollment(participants)W-SUDsDigitally-delivered PsychoeducationTotal
United States10795202
Gender
Gender(Participants)W-SUDsDigitally-delivered PsychoeducationTotal
Woman5056106
Man563793
Non-binary123
Sexual Orientation
Sexual Orientation(Participants)W-SUDsDigitally-delivered PsychoeducationTotal
Heterosexual9084174
Gay or Lesbian8210
Bisexual5510
Queer011
Pansexual235
Don't know202
Marital Status
Marital Status(Participants)W-SUDsDigitally-delivered PsychoeducationTotal
Married/Cohabitating/Partnered5352105
Divorced/Separated/Widowed13922
Never married/Single413475

10 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Stanford University
    Palo Alto, California 94304, United States
09

References and documents

Study documents

  • Study protocol · Mar 17, 2023
  • Statistical analysis plan · Mar 17, 2023
  • Informed consent form · Mar 17, 2023

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04925570
Lead sponsor
Woebot Health
Collaborators
Stanford University
Responsible party
Sponsor
First posted
Jun 14, 2021
Start date
Nov 14, 2022
Primary completion
Aug 17, 2023
Completion
Aug 17, 2023
Results posted
Oct 24, 2024
Last update
Oct 24, 2024

Study contacts

Judith Prochaska, PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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