Substance Use Disorders
Conditions
Brief summary
Phase 1 of this study aims to develop a digitally-delivered substance use disorder program through the Woebot app-based platform (W-SUDs) and evaluate the effectiveness of, patient satisfaction with and the acceptability of W-SUDs as a substance use management tool.
Interventions
DEVICEWoebot-SUDs (W-SUDs)
Woebot-SUDs (W-SUDS), an artificially intelligence-powered conversational agent on a smartphone app, eliminates most current SUDs treatment barriers while simultaneously leveraging technology to enhance user experience and engagement. W-SUDs expands and refines existing SUDs treatments by adapting skills from cognitive behavioral therapy, motivational interviewing, and dialectical behavior therapy.
Sponsors
Stanford University
Woebot Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* All genders * 18-65 years * Must have access to a smartphone and able to download the W-SUDs app * Committed to engage with app and complete assessments * Be willing to provide email address (to distribute incentives) * Be literate in English (as W-SUDs conversational and video materials will be in English) * Endorse a substance use concern according to the DAST-10 and/or AUDIT-C scale cutoffs for problematic use
Exclusion criteria
* Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population) * Suicide attempt or within the past year * Drug or alcohol overdose within the past year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) From Baseline to Post-treatment at 8 Weeks | Change from Baseline to Post-treatment at 8 weeks | The AUDIT-C is a widely used 3-item self-report screen for hazardous or harmful alcohol consumption that is based off of the 10-item original AUDIT. The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety. |
| Change in The Drug Abuse Screening Test 10 (DAST-10) From Baseline to Post-treatment at 8 Weeks | Change from Baseline to Post-treatment at 8 weeks | The DAST-10 is a brief, 10-item self-report assesses consequences related to drug abuse, excluding alcohol and tobacco. The range is 0-10, where higher scores indicate greater severity. |
| Change in Number of Days Substance Use From Baseline to Post-treatment at 8 Weeks | Change from Baseline and Post-treatment at 8 weeks | The number of days a substance was used the past 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks | Change from Mid-treatment at 4 weeks to 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. Scores range from 15-60, 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. |
| Change Patient Health Questionnaire (PHQ-8) From Baseline to Post-Treatment at 8 Weeks | Change from Baseline to Post-Treatment at 8 weeks | Measure of depression severity. Total score between 0-27, where higher scores indicate greater levels of depression. |
| The Client Satisfaction Questionnaire (CSQ-8) at Post-treatment at 8 Weeks | Post-treatment at 8 weeks | The CSQ-8 is an 8-item self-report scale measuring satisfaction with treatment. Scores from 8 to 32, with higher values indicating higher satisfaction. |
| Change Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-Treatment at 8 Weeks | Change from Baseline to Post-treatment at 8 weeks | 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. |
| Change Pain Rating From Baseline to Post-Treatment at 8 Weeks | Change from Baseline to Post-treatment at 8 weeks | Range from 0-100 (no pain to worst pain imaginable). |
| Change Generalized Anxiety Disorder (GAD-7) From Baseline to Post-Treatment at 8 Weeks | Change from Baseline to Post-Treatment at 8 weeks | Measure of anxiety. Total score between 0-21, where higher scores indicate greater levels of anxiety. |
| Usage Rating Profile Intervention (URPI) - Acceptability at Post-treatment at 8 Weeks | Post-treatment at 8 weeks | URPI-Acceptability Subscale is 6-item subscale from the URP Intervention Revised (URP-IR) scale. The URPI-Acceptability inquires about intervention acceptability. Responses range from 1= slightly disagree to 6=strongly agree. Scores are averages, with greater scores indicating greater intervention acceptability. |
| Usage Rating Profile Intervention (URPI) - Feasibility at Post-treatment at 8 Weeks | Post-treatment at 8 weeks | URPI-Feasibility Subscale is 6-item subscale from the URP Intervention Revised (URP-IR) scale. The URPI-Feasibility inquires about factors that impact treatment usage (i.e., intervention quality). Responses range from 1= slightly disagree to 6=strongly agree. Scores are averages, with greater scores indicating greater intervention feasibility. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Woebot-SUDs (W-SUDs) Woebot-SUDs (W-SUDS), an artificially intelligence-powered conversational agent on a smartphone app, eliminates most current SUDs treatment barriers while simultaneously leveraging technology to enhance user experience and engagement. W-SUDs expands and refines existing SUDs treatments by adapting skills from cognitive behavioral therapy, motivational interviewing, and dialectical behavior therapy. | 101 |
| Total | 101 |
Baseline characteristics
| Characteristic | Woebot-SUDs (W-SUDs) |
|---|---|
| Age, Continuous | 36.8 years STANDARD_DEVIATION 10 |
| Alcohol Use Disorders Identification Test-Concise Men | 5.2 units on a scale STANDARD_DEVIATION 3.2 |
| Alcohol Use Disorders Identification Test-Concise Women | 5.5 units on a scale STANDARD_DEVIATION 3.1 |
| Bothered by cravings in the past 7 days A little bit | 31 Participants |
| Bothered by cravings in the past 7 days Extremely | 7 Participants |
| Bothered by cravings in the past 7 days Moderately | 33 Participants |
| Bothered by cravings in the past 7 days Not at all | 7 Participants |
| Bothered by cravings in the past 7 days Quite a bit | 23 Participants |
| Brief Situational Confidence Questionnaire (BSCQ) | 48.1 units on a scale STANDARD_DEVIATION 22.1 |
| COVID-19 situation No restrictions | 2 Participants |
| COVID-19 situation Sheltering in place, lockdown, quarantined | 99 Participants |
| Drug Abuse Screening Test-10 item | 3.0 units on a scale STANDARD_DEVIATION 2.6 |
| Employment status Employed full-time | 62 Participants |
| Employment status Employed part-time | 11 Participants |
| Employment status Other (eg, retired, disabled, homemaker, and student) | 16 Participants |
| Employment status Unemployed, job-seeking | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 92 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| General Anxiety Disorder-7 item anxiety | 9.6 units on a scale STANDARD_DEVIATION 5.7 |
| Lifetime psychiatric diagnoses Anxiety disorder | 49 participants |
| Lifetime psychiatric diagnoses Attention deficit hyperactivity disorder | 15 participants |
| Lifetime psychiatric diagnoses Bipolar or manic depression | 10 participants |
| Lifetime psychiatric diagnoses Multiple psychiatric diagnoses | 48 participants |
| Lifetime psychiatric diagnoses No lifetime psychiatric diagnoses | 28 participants |
| Lifetime psychiatric diagnoses Other (eg, obsessive compulsive disorder, eating disorder, and personality disorder) | 12 participants |
| Lifetime psychiatric diagnoses Posttraumatic stress disorder | 19 participants |
| Lifetime psychiatric diagnoses Substance use disorder | 6 participants |
| Lifetime psychiatric diagnoses Unipolar depression | 45 participants |
| Marital status Divorced or separated or widowed | 14 Participants |
| Marital status Married or cohabitating or partnered | 54 Participants |
| Marital status Single or never married | 33 Participants |
| Number of substance use occasions in the past 30 days | 31.8 occassions STANDARD_DEVIATION 17.7 |
| Pain intensity in the past 7 days (possible range 0-100) | 20.4 units on a scale STANDARD_DEVIATION 22.3 |
| Pain interfere with normal work in the past 30 days A little bit | 23 Participants |
| Pain interfere with normal work in the past 30 days Extremely | 2 Participants |
| Pain interfere with normal work in the past 30 days Moderately | 9 Participants |
| Pain interfere with normal work in the past 30 days Not at all | 60 Participants |
| Pain interfere with normal work in the past 30 days Quite a bit | 7 Participants |
| Past 30 days of substance use Alcohol | 88 Participants |
| Past 30 days of substance use Cannabis | 50 Participants |
| Past 30 days of substance use Cocaine | 5 Participants |
| Past 30 days of substance use Hallucinogens | 10 Participants |
| Past 30 days of substance use Inhalants | 4 Participants |
| Past 30 days of substance use Methamphetamine | 4 Participants |
| Past 30 days of substance use Prescription opioids | 5 Participants |
| Past 30 days of substance use Prescription stimulants | 10 Participants |
| Past 30 days of substance use Sedatives | 19 Participants |
| Past 30 days of substance use Street opioids | 0 Participants |
| Patient Health Questionnaire-8 item depression | 10.8 units on a scale STANDARD_DEVIATION 5.8 |
| Primary substance Alcohol | 69 Participants |
| Primary substance Cannabis | 20 Participants |
| Primary substance Indicated multi-substances | 37 Participants |
| Primary substance Other (eg, club drugs, pain killers, and sedatives) | 5 Participants |
| Primary substance Stimulants or cocaine | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 80 Participants |
| Sex: Female, Male Female | 77 Participants |
| Sex: Female, Male Male | 24 Participants |
| Therapy experience Currently | 26 participants |
| Therapy experience Currently taking psychiatric medication | 44 participants |
| Therapy experience Formerly | 45 participants |
| Therapy experience Never | 30 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 101 |
| other Total, other adverse events | 0 / 101 |
| serious Total, serious adverse events | 1 / 101 |
Outcome results
Primary
Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) From Baseline to Post-treatment at 8 Weeks
The AUDIT-C is a widely used 3-item self-report screen for hazardous or harmful alcohol consumption that is based off of the 10-item original AUDIT. The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.
Time frame: Change from Baseline to Post-treatment at 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Woebot-SUDs (W-SUDs) | Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) From Baseline to Post-treatment at 8 Weeks | -9.3 score on a scale | Standard Deviation 4.1 |
Primary
Change in Number of Days Substance Use From Baseline to Post-treatment at 8 Weeks
The number of days a substance was used the past 30 days
Time frame: Change from Baseline and Post-treatment at 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Woebot-SUDs (W-SUDs) | Change in Number of Days Substance Use From Baseline to Post-treatment at 8 Weeks | -9.3 days | Standard Deviation 14.1 |
Primary
Change in The Drug Abuse Screening Test 10 (DAST-10) From Baseline to Post-treatment at 8 Weeks
The DAST-10 is a brief, 10-item self-report assesses consequences related to drug abuse, excluding alcohol and tobacco. The range is 0-10, where higher scores indicate greater severity.
Time frame: Change from Baseline to Post-treatment at 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Woebot-SUDs (W-SUDs) | Change in The Drug Abuse Screening Test 10 (DAST-10) From Baseline to Post-treatment at 8 Weeks | -1.2 score on a scale | Standard Deviation 2 |
Secondary
Change Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-Treatment at 8 Weeks
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 Post-treatment at 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Woebot-SUDs (W-SUDs) | Change Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-Treatment at 8 Weeks | 16.9 units on a scale | Standard Deviation 21.4 |
Secondary
Change From Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to 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. Scores range from 15-60, 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: Change from Mid-treatment at 4 weeks to Post-treatment at 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Woebot-SUDs (W-SUDs) | Change From Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks | 40.8 score on a scale | Standard Deviation 12.5 |
Secondary
Change Generalized Anxiety Disorder (GAD-7) From Baseline to Post-Treatment at 8 Weeks
Measure of anxiety. Total score between 0-21, where higher scores indicate greater levels of anxiety.
Time frame: Change from Baseline to Post-Treatment at 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Woebot-SUDs (W-SUDs) | Change Generalized Anxiety Disorder (GAD-7) From Baseline to Post-Treatment at 8 Weeks | -2.3 score on a scale | Standard Deviation 4.8 |
Secondary
Change Pain Rating From Baseline to Post-Treatment at 8 Weeks
Range from 0-100 (no pain to worst pain imaginable).
Time frame: Change from Baseline to Post-treatment at 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Woebot-SUDs (W-SUDs) | Change Pain Rating From Baseline to Post-Treatment at 8 Weeks | 24.2 score on a scale | Standard Deviation 22 |
Secondary
Change Patient Health Questionnaire (PHQ-8) From Baseline to Post-Treatment at 8 Weeks
Measure of depression severity. Total score between 0-27, where higher scores indicate greater levels of depression.
Time frame: Change from Baseline to Post-Treatment at 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Woebot-SUDs (W-SUDs) | Change Patient Health Questionnaire (PHQ-8) From Baseline to Post-Treatment at 8 Weeks | 8.6 score on a scale | Standard Deviation 5.1 |
Secondary
The Client Satisfaction Questionnaire (CSQ-8) at Post-treatment at 8 Weeks
The CSQ-8 is an 8-item self-report scale measuring satisfaction with treatment. Scores from 8 to 32, with higher values indicating higher satisfaction.
Time frame: Post-treatment at 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Woebot-SUDs (W-SUDs) | The Client Satisfaction Questionnaire (CSQ-8) at Post-treatment at 8 Weeks | 23.2 score on a scale | Standard Deviation 5.5 |
Secondary
Usage Rating Profile Intervention (URPI) - Acceptability at Post-treatment at 8 Weeks
URPI-Acceptability Subscale is 6-item subscale from the URP Intervention Revised (URP-IR) scale. The URPI-Acceptability inquires about intervention acceptability. Responses range from 1= slightly disagree to 6=strongly agree. Scores are averages, with greater scores indicating greater intervention acceptability.
Time frame: Post-treatment at 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Woebot-SUDs (W-SUDs) | Usage Rating Profile Intervention (URPI) - Acceptability at Post-treatment at 8 Weeks | 25.6 score on a scale | Standard Deviation 7.3 |
Secondary
Usage Rating Profile Intervention (URPI) - Feasibility at Post-treatment at 8 Weeks
URPI-Feasibility Subscale is 6-item subscale from the URP Intervention Revised (URP-IR) scale. The URPI-Feasibility inquires about factors that impact treatment usage (i.e., intervention quality). Responses range from 1= slightly disagree to 6=strongly agree. Scores are averages, with greater scores indicating greater intervention feasibility.
Time frame: Post-treatment at 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Woebot-SUDs (W-SUDs) | Usage Rating Profile Intervention (URPI) - Feasibility at Post-treatment at 8 Weeks | 28.5 score on a scale | Standard Deviation 5.7 |