Alcohol Use Disorder (AUD), Substance Use Disorders
Conditions
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
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.
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.
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.
Sponsors
Stanford University
Woebot Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Substance Use Occasions | 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 | Change in number of substance use occasions in the past 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Working Alliance Inventory (WAI-SR) | Post-treatment at 8 weeks | 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. |
| Stanford Presenteeism Scale (SPS-6) | Change from Baseline to Post-treatment at 8 weeks | 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. |
| Thoughts About Abstinence (TAA): Desire to Quit, Expected Success at Quitting, Expected Difficulty of Quitting Items | Change from Baseline to Post-treatment at 8 weeks | 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. |
| Thoughts About Abstinence (TAA): Goal Item | Baseline and Post-treatment at 8 weeks | 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. |
| Usage Rating Profile - Intervention (URPI)-Acceptability | Post-treatment at 8 weeks | 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. |
| Usage Rating Profile - Intervention (URPI)-Feasibility | Post-treatment at 8 weeks | 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. |
| Client Satisfaction Questionnaire (CSQ-8) | Post-treatment at 8 weeks | 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. |
| Drug Abuse Screening Test (DAST-10) | Change from Baseline to Post-treatment at 8 weeks | 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. |
| Patient Health Questionnaire (PHQ-8) | 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 | 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. |
| Generalized Anxiety Disorder (GAD-7) | 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 | 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. |
| Brief Situational Confidence Questionnaire (BSCQ) | 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 | 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. |
| Craving Ratings | 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 | 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. |
| Past Month Number of Binge Days | 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 | 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). |
| Past Month Average Standard Drinks in a Week | 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 | 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. |
| Short Inventory of Problems- Alcohol and Drugs (SIP-AD) | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 107 |
| 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.
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. | 95 |
| Total | 202 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 24 | 30 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Digitally-delivered Psychoeducation | Total | W-SUDs |
|---|---|---|---|
| Age, Continuous | 38.6 years STANDARD_DEVIATION 9.2 | 38.3 years STANDARD_DEVIATION 10.4 | 38.2 years STANDARD_DEVIATION 11.4 |
| Disability Status No (does not have a disability) | 85 Participants | 183 Participants | 98 Participants |
| Disability Status Prefer not to answer | 0 Participants | 1 Participants | 1 Participants |
| Disability Status Yes (has a disability) | 10 Participants | 18 Participants | 8 Participants |
| Educational Degree College Degree | 27 Participants | 57 Participants | 30 Participants |
| Educational Degree Graduate or Post-graduate Degree | 19 Participants | 42 Participants | 23 Participants |
| Educational Degree High School Degree or Less | 13 Participants | 30 Participants | 17 Participants |
| Educational Degree Some College/Technical School | 36 Participants | 73 Participants | 37 Participants |
| Employment Status Employed Part or Full-Time | 61 Participants | 135 Participants | 74 Participants |
| Employment Status Unemployed (homemaker, student, retired) | 34 Participants | 67 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 23 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 84 Participants | 178 Participants | 94 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Gender Man | 37 Participants | 93 Participants | 56 Participants |
| Gender Non-binary | 2 Participants | 3 Participants | 1 Participants |
| Gender Woman | 56 Participants | 106 Participants | 50 Participants |
| Insurance Status Doesn't have insurance | 10 Participants | 28 Participants | 18 Participants |
| Insurance Status Medicaid or Medicare | 33 Participants | 65 Participants | 32 Participants |
| Insurance Status Prefer not to answer | 2 Participants | 2 Participants | 0 Participants |
| Insurance Status Private | 47 Participants | 103 Participants | 56 Participants |
| Insurance Status TRICARE | 2 Participants | 2 Participants | 0 Participants |
| Insurance Status VA | 1 Participants | 2 Participants | 1 Participants |
| Lifetime Mental Health Condition Anxiety Disorder | 32 participants | 66 participants | 34 participants |
| Lifetime Mental Health Condition Bipolar/Manic Depression | 5 participants | 14 participants | 9 participants |
| Lifetime Mental Health Condition Multiple Diagnoses | 26 participants | 55 participants | 29 participants |
| Lifetime Mental Health Condition No History of Mental Illness | 48 participants | 111 participants | 62 participants |
| Lifetime Mental Health Condition Other Mental Health Disorder | 24 participants | 47 participants | 23 participants |
| Lifetime Mental Health Condition Substance Use Disorder | 7 participants | 15 participants | 8 participants |
| Lifetime Mental Health Condition Unipolar Depression | 26 participants | 48 participants | 20 participants |
| Marital Status Divorced/Separated/Widowed | 9 Participants | 22 Participants | 13 Participants |
| Marital Status Married/Cohabitating/Partnered | 52 Participants | 105 Participants | 53 Participants |
| Marital Status Never married/Single | 34 Participants | 75 Participants | 41 Participants |
| Past 30 Day Medication Use for SUD Treatment No (Did not use medication) | 94 Participants | 199 Participants | 105 Participants |
| Past 30 Day Medication Use for SUD Treatment Yes (Used medication) | 1 Participants | 3 Participants | 2 Participants |
| Past 30 Day SUD Treatment Intensive Outpatient/Residential | 2 Participants | 4 Participants | 2 Participants |
| Past 30 Day SUD Treatment No Treatment | 83 Participants | 181 Participants | 98 Participants |
| Past 30 Day SUD Treatment Outpatient Services | 5 Participants | 10 Participants | 5 Participants |
| Past 30 Day SUD Treatment Self-help Groups | 5 Participants | 7 Participants | 2 Participants |
| Primary, Secondary, or Tertiary Problematic Substance Alcohol | 72 participants | 148 participants | 76 participants |
| Primary, Secondary, or Tertiary Problematic Substance Cannabis | 35 participants | 62 participants | 27 participants |
| Primary, Secondary, or Tertiary Problematic Substance Cocaine | 9 participants | 25 participants | 16 participants |
| Primary, Secondary, or Tertiary Problematic Substance Other (e.g., Heroin, Hallucinogens, Inhalants) | 15 participants | 37 participants | 22 participants |
| Primary, Secondary, or Tertiary Problematic Substance Stimulants | 15 participants | 35 participants | 20 participants |
| Primary, Secondary, or Tertiary Problematic Substance Tobacco | 34 participants | 70 participants | 36 participants |
| Prior Therapy Experience Currently in Therapy | 18 Participants | 31 Participants | 13 Participants |
| Prior Therapy Experience Formerly in Therapy | 25 Participants | 53 Participants | 28 Participants |
| Prior Therapy Experience Never in Therapy | 52 Participants | 118 Participants | 66 Participants |
| Psychiatric Medications Currently Taking Psychiatric Medications | 17 Participants | 42 Participants | 25 Participants |
| Psychiatric Medications Not Currently Taking Psychiatric Medications | 78 Participants | 160 Participants | 82 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants | 45 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 58 Participants | 144 Participants | 86 Participants |
| Region of Enrollment United States | 95 participants | 202 participants | 107 participants |
| Sex: Female, Male Female | 58 Participants | 108 Participants | 50 Participants |
| Sex: Female, Male Male | 37 Participants | 94 Participants | 57 Participants |
| Sexual Orientation Bisexual | 5 Participants | 10 Participants | 5 Participants |
| Sexual Orientation Don't know | 0 Participants | 2 Participants | 2 Participants |
| Sexual Orientation Gay or Lesbian | 2 Participants | 10 Participants | 8 Participants |
| Sexual Orientation Heterosexual | 84 Participants | 174 Participants | 90 Participants |
| Sexual Orientation Pansexual | 3 Participants | 5 Participants | 2 Participants |
| Sexual Orientation Queer | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 107 | 0 / 95 |
| other Total, other adverse events | 0 / 107 | 0 / 95 |
| serious Total, serious adverse events | 0 / 107 | 0 / 95 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| W-SUDs | Change in Number of Substance Use Occasions | Week 4 | -11.3 occasions | Standard Deviation 15.9 |
| W-SUDs | Change in Number of Substance Use Occasions | Week 8 | -13.6 occasions | Standard Deviation 15.4 |
| W-SUDs | Change in Number of Substance Use Occasions | Week 12 | -15.7 occasions | Standard Deviation 18 |
| Digitally-delivered Psychoeducation | Change in Number of Substance Use Occasions | Week 4 | -11.2 occasions | Standard Deviation 12.9 |
| Digitally-delivered Psychoeducation | Change in Number of Substance Use Occasions | Week 8 | -12.9 occasions | Standard Deviation 15.3 |
| Digitally-delivered Psychoeducation | Change in Number of Substance Use Occasions | Week 12 | -15.4 occasions | Standard Deviation 16.6 |
Secondary
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
Population: Number analyzed for each timepoint differs from the overall number analyzed due to missingness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| W-SUDs | Brief Situational Confidence Questionnaire (BSCQ) | Mid-treatment at 4 weeks | 7.3 score on a scale | Standard Deviation 21.4 |
| W-SUDs | Brief Situational Confidence Questionnaire (BSCQ) | Post-treatment at 8 weeks | 6.77 score on a scale | Standard Deviation 20.4 |
| W-SUDs | Brief Situational Confidence Questionnaire (BSCQ) | Follow-up at 12 weeks | 11.6 score on a scale | Standard Deviation 21.8 |
| Digitally-delivered Psychoeducation | Brief Situational Confidence Questionnaire (BSCQ) | Mid-treatment at 4 weeks | 10.4 score on a scale | Standard Deviation 23.2 |
| Digitally-delivered Psychoeducation | Brief Situational Confidence Questionnaire (BSCQ) | Post-treatment at 8 weeks | 11.6 score on a scale | Standard Deviation 20.3 |
| Digitally-delivered Psychoeducation | Brief Situational Confidence Questionnaire (BSCQ) | Follow-up at 12 weeks | 15.6 score on a scale | Standard Deviation 26.1 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| W-SUDs | Client Satisfaction Questionnaire (CSQ-8) | 26.9 score on a scale | Standard Deviation 5.2 |
| Digitally-delivered Psychoeducation | Client Satisfaction Questionnaire (CSQ-8) | 28.1 score on a scale | Standard Deviation 4.5 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| W-SUDs | Craving Ratings | Mid-treatment at 4 weeks | -0.418 score on a scale | Standard Deviation 0.994 |
| W-SUDs | Craving Ratings | Post-treatment at 8 weeks | -0.66 score on a scale | Standard Deviation 1.18 |
| W-SUDs | Craving Ratings | Follow-up at 12 weeks | -0.816 score on a scale | Standard Deviation 1.15 |
| Digitally-delivered Psychoeducation | Craving Ratings | Follow-up at 12 weeks | -0.892 score on a scale | Standard Deviation 1.4 |
| Digitally-delivered Psychoeducation | Craving Ratings | Mid-treatment at 4 weeks | -0.56 score on a scale | Standard Deviation 1.14 |
| Digitally-delivered Psychoeducation | Craving Ratings | Post-treatment at 8 weeks | -0.722 score on a scale | Standard Deviation 1.2 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| W-SUDs | Drug Abuse Screening Test (DAST-10) | -1.21 score on a scale | Standard Deviation 2.33 |
| Digitally-delivered Psychoeducation | Drug Abuse Screening Test (DAST-10) | -1.95 score on a scale | Standard Deviation 1.99 |
Secondary
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
Population: Number analyzed for each timepoint differs from the overall number analyzed due to missingness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| W-SUDs | Generalized Anxiety Disorder (GAD-7) | Mid-treatment at 4 weeks | -1.31 score on a scale | Standard Deviation 4.05 |
| W-SUDs | Generalized Anxiety Disorder (GAD-7) | Post-treatment at 8 weeks | -1.88 score on a scale | Standard Deviation 4.77 |
| W-SUDs | Generalized Anxiety Disorder (GAD-7) | Follow-up at 12 weeks | -2.09 score on a scale | Standard Deviation 4.67 |
| Digitally-delivered Psychoeducation | Generalized Anxiety Disorder (GAD-7) | Mid-treatment at 4 weeks | -1.56 score on a scale | Standard Deviation 3.97 |
| Digitally-delivered Psychoeducation | Generalized Anxiety Disorder (GAD-7) | Post-treatment at 8 weeks | -1.72 score on a scale | Standard Deviation 4.91 |
| Digitally-delivered Psychoeducation | Generalized Anxiety Disorder (GAD-7) | Follow-up at 12 weeks | -2.57 score on a scale | Standard Deviation 5.08 |
Secondary
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
Population: Number analyzed for each timepoint differs from the overall number analyzed due to missingness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| W-SUDs | Past Month Average Standard Drinks in a Week | Mid-treatment at 4 weeks | -7.62 Drinks per week | Standard Deviation 14.9 |
| W-SUDs | Past Month Average Standard Drinks in a Week | Post-treatment at 8 weeks | -8.67 Drinks per week | Standard Deviation 14.7 |
| W-SUDs | Past Month Average Standard Drinks in a Week | Follow-up at 12 weeks | -11.1 Drinks per week | Standard Deviation 15.7 |
| Digitally-delivered Psychoeducation | Past Month Average Standard Drinks in a Week | Mid-treatment at 4 weeks | -6.92 Drinks per week | Standard Deviation 12.4 |
| Digitally-delivered Psychoeducation | Past Month Average Standard Drinks in a Week | Post-treatment at 8 weeks | -8.18 Drinks per week | Standard Deviation 11.5 |
| Digitally-delivered Psychoeducation | Past Month Average Standard Drinks in a Week | Follow-up at 12 weeks | -9.43 Drinks per week | Standard Deviation 13.9 |
Secondary
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
Population: Number analyzed for each timepoint differs from the overall number analyzed due to missingness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| W-SUDs | Past Month Number of Binge Days | Mid-treatment at 4 weeks | -4.26 days | Standard Deviation 6.88 |
| W-SUDs | Past Month Number of Binge Days | Post-treatment at 8 weeks | -4.09 days | Standard Deviation 6.35 |
| W-SUDs | Past Month Number of Binge Days | Follow-up at 12 weeks | -5.43 days | Standard Deviation 7.21 |
| Digitally-delivered Psychoeducation | Past Month Number of Binge Days | Mid-treatment at 4 weeks | -2.45 days | Standard Deviation 5.66 |
| Digitally-delivered Psychoeducation | Past Month Number of Binge Days | Post-treatment at 8 weeks | -2.51 days | Standard Deviation 6.02 |
| Digitally-delivered Psychoeducation | Past Month Number of Binge Days | Follow-up at 12 weeks | -3.14 days | Standard Deviation 7.75 |
Secondary
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
Population: Number analyzed for each timepoint differs from the overall number analyzed due to missingness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| W-SUDs | Patient Health Questionnaire (PHQ-8) | Mid-treatment at 4 weeks | -1.84 score on a scale | Standard Deviation 4.24 |
| W-SUDs | Patient Health Questionnaire (PHQ-8) | Post-treatment at 8 weeks | -2.82 score on a scale | Standard Deviation 4.65 |
| W-SUDs | Patient Health Questionnaire (PHQ-8) | Follow-up at 12 weeks | -2.83 score on a scale | Standard Deviation 4.79 |
| Digitally-delivered Psychoeducation | Patient Health Questionnaire (PHQ-8) | Mid-treatment at 4 weeks | -1.44 score on a scale | Standard Deviation 4.45 |
| Digitally-delivered Psychoeducation | Patient Health Questionnaire (PHQ-8) | Post-treatment at 8 weeks | -2.05 score on a scale | Standard Deviation 5.95 |
| Digitally-delivered Psychoeducation | Patient Health Questionnaire (PHQ-8) | Follow-up at 12 weeks | -2.87 score on a scale | Standard Deviation 6.3 |
Secondary
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
Population: Number analyzed for each timepoint differs from the overall number analyzed due to missingness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| W-SUDs | Short Inventory of Problems- Alcohol and Drugs (SIP-AD) | Mid-treatment at 4 weeks | -8.02 score on a scale | Standard Deviation 9.35 |
| W-SUDs | Short Inventory of Problems- Alcohol and Drugs (SIP-AD) | Post-treatment at 8 weeks | -9.02 score on a scale | Standard Deviation 11.6 |
| W-SUDs | Short Inventory of Problems- Alcohol and Drugs (SIP-AD) | Follow-up at 12 weeks | -11.5 score on a scale | Standard Deviation 11.5 |
| Digitally-delivered Psychoeducation | Short Inventory of Problems- Alcohol and Drugs (SIP-AD) | Follow-up at 12 weeks | -10.9 score on a scale | Standard Deviation 11.5 |
| Digitally-delivered Psychoeducation | Short Inventory of Problems- Alcohol and Drugs (SIP-AD) | Mid-treatment at 4 weeks | -7.39 score on a scale | Standard Deviation 9.95 |
| Digitally-delivered Psychoeducation | Short Inventory of Problems- Alcohol and Drugs (SIP-AD) | Post-treatment at 8 weeks | -9.24 score on a scale | Standard Deviation 10.2 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| W-SUDs | Stanford Presenteeism Scale (SPS-6) | -5.42 score on a scale | Standard Deviation 7.2 |
| Digitally-delivered Psychoeducation | Stanford Presenteeism Scale (SPS-6) | -4.12 score on a scale | Standard Deviation 6.97 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| W-SUDs | Thoughts About Abstinence (TAA): Desire to Quit, Expected Success at Quitting, Expected Difficulty of Quitting Items | Desire to quit | 0.21 score on a scale | Standard Deviation 2.33 |
| W-SUDs | Thoughts About Abstinence (TAA): Desire to Quit, Expected Success at Quitting, Expected Difficulty of Quitting Items | Expected success at quitting | 0.42 score on a scale | Standard Deviation 2.37 |
| W-SUDs | Thoughts About Abstinence (TAA): Desire to Quit, Expected Success at Quitting, Expected Difficulty of Quitting Items | Expected difficulty of quitting | -0.64 score on a scale | Standard Deviation 2.44 |
| Digitally-delivered Psychoeducation | Thoughts About Abstinence (TAA): Desire to Quit, Expected Success at Quitting, Expected Difficulty of Quitting Items | Desire to quit | 0.12 score on a scale | Standard Deviation 2.71 |
| Digitally-delivered Psychoeducation | Thoughts About Abstinence (TAA): Desire to Quit, Expected Success at Quitting, Expected Difficulty of Quitting Items | Expected success at quitting | 0.53 score on a scale | Standard Deviation 2.72 |
| Digitally-delivered Psychoeducation | Thoughts About Abstinence (TAA): Desire to Quit, Expected Success at Quitting, Expected Difficulty of Quitting Items | Expected difficulty of quitting | -0.28 score on a scale | Standard Deviation 2.91 |
Secondary
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
Population: Number analyzed in categories reported at 8 weeks differs from overall number analyzed due to data missingness.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| W-SUDs | Thoughts About Abstinence (TAA): Goal Item | Prefer not to answer (8 weeks) | 0 participants |
| W-SUDs | Thoughts About Abstinence (TAA): Goal Item | No goal (Baseline) | 10 participants |
| W-SUDs | Thoughts About Abstinence (TAA): Goal Item | Controlled use (Baseline) | 25 participants |
| W-SUDs | Thoughts About Abstinence (TAA): Goal Item | Short-term abstinence (Baseline) | 14 participants |
| W-SUDs | Thoughts About Abstinence (TAA): Goal Item | Occasional use when there is urge (Baseline) | 17 participants |
| W-SUDs | Thoughts About Abstinence (TAA): Goal Item | Quit, but might slip (Baseline) | 13 participants |
| W-SUDs | Thoughts About Abstinence (TAA): Goal Item | Quit forever (Baseline) | 25 participants |
| W-SUDs | Thoughts About Abstinence (TAA): Goal Item | Other (Baseline) | 3 participants |
| W-SUDs | Thoughts About Abstinence (TAA): Goal Item | No goal (8 weeks) | 16 participants |
| W-SUDs | Thoughts About Abstinence (TAA): Goal Item | Controlled use (8 weeks) | 19 participants |
| W-SUDs | Thoughts About Abstinence (TAA): Goal Item | Short-term abstinence, then decide about continued use (8 weeks) | 15 participants |
| W-SUDs | Thoughts About Abstinence (TAA): Goal Item | Occasional use when there is urge (8 weeks) | 8 participants |
| W-SUDs | Thoughts About Abstinence (TAA): Goal Item | Quit, but might slip (8 weeks) | 14 participants |
| W-SUDs | Thoughts About Abstinence (TAA): Goal Item | Quit forever (8 weeks) | 25 participants |
| W-SUDs | Thoughts About Abstinence (TAA): Goal Item | Other (8 weeks) | 3 participants |
| Digitally-delivered Psychoeducation | Thoughts About Abstinence (TAA): Goal Item | Prefer not to answer (8 weeks) | 1 participants |
| Digitally-delivered Psychoeducation | Thoughts About Abstinence (TAA): Goal Item | No goal (8 weeks) | 12 participants |
| Digitally-delivered Psychoeducation | Thoughts About Abstinence (TAA): Goal Item | No goal (Baseline) | 12 participants |
| Digitally-delivered Psychoeducation | Thoughts About Abstinence (TAA): Goal Item | Quit, but might slip (8 weeks) | 11 participants |
| Digitally-delivered Psychoeducation | Thoughts About Abstinence (TAA): Goal Item | Controlled use (Baseline) | 22 participants |
| Digitally-delivered Psychoeducation | Thoughts About Abstinence (TAA): Goal Item | Controlled use (8 weeks) | 28 participants |
| Digitally-delivered Psychoeducation | Thoughts About Abstinence (TAA): Goal Item | Short-term abstinence (Baseline) | 9 participants |
| Digitally-delivered Psychoeducation | Thoughts About Abstinence (TAA): Goal Item | Other (8 weeks) | 5 participants |
| Digitally-delivered Psychoeducation | Thoughts About Abstinence (TAA): Goal Item | Occasional use when there is urge (Baseline) | 19 participants |
| Digitally-delivered Psychoeducation | Thoughts About Abstinence (TAA): Goal Item | Short-term abstinence, then decide about continued use (8 weeks) | 6 participants |
| Digitally-delivered Psychoeducation | Thoughts About Abstinence (TAA): Goal Item | Quit, but might slip (Baseline) | 11 participants |
| Digitally-delivered Psychoeducation | Thoughts About Abstinence (TAA): Goal Item | Quit forever (8 weeks) | 21 participants |
| Digitally-delivered Psychoeducation | Thoughts About Abstinence (TAA): Goal Item | Quit forever (Baseline) | 18 participants |
| Digitally-delivered Psychoeducation | Thoughts About Abstinence (TAA): Goal Item | Occasional use when there is urge (8 weeks) | 6 participants |
| Digitally-delivered Psychoeducation | Thoughts About Abstinence (TAA): Goal Item | Other (Baseline) | 4 participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| W-SUDs | Usage Rating Profile - Intervention (URPI)-Acceptability | 30.1 score on a scale | Standard Deviation 5.6 |
| Digitally-delivered Psychoeducation | Usage Rating Profile - Intervention (URPI)-Acceptability | 30.3 score on a scale | Standard Deviation 5.8 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| W-SUDs | Usage Rating Profile - Intervention (URPI)-Feasibility | 28.0 score on a scale | Standard Deviation 3.5 |
| Digitally-delivered Psychoeducation | Usage Rating Profile - Intervention (URPI)-Feasibility | 29.8 score on a scale | Standard Deviation 2.6 |
Secondary
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
Population: Number analyzed for each subscale differs from the overall number analyzed due to missingness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| W-SUDs | Working Alliance Inventory (WAI-SR) | Goal | 14.8 score on a scale | Standard Deviation 4.4 |
| W-SUDs | Working Alliance Inventory (WAI-SR) | Task | 14.4 score on a scale | Standard Deviation 4.5 |
| W-SUDs | Working Alliance Inventory (WAI-SR) | Bond | 15.2 score on a scale | Standard Deviation 4.5 |