Alcohol Use Disorder, Substance Use Disorders
Conditions
Brief summary
The purpose of this study is to test the efficacy of a substance use disorder intervention delivered via a mobile application in an adult population during the COVID-19 pandemic. This study that will test the comparative efficacy of the mobile-app based substance use disorder program to reduce substance use relative to a wait list control condition, and explore between group differences on quality of life indices as well as retention and engagement during COVID-19.
Interventions
OTHERWoebot Substance Use Disorder
Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.
Sponsors
Stanford University
National Institute on Drug Abuse (NIDA)
Woebot Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* All genders aged 18-65 years * Access to a smartphone * Available and committed to engage with app and complete assessments * Be willing to provide email address (as this is how assessment incentives will be distributed), * Literate in English (as W-SUDs conversational and video materials will be in English).
Exclusion criteria
* Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population) * History of severe drug/alcohol use * History of opioid misuse without medication-assisted treatment * Suicide attempt within the past year * Opioid overdose within the past year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks | Change from Baseline to Post-treatment at 8 weeks | Change in number of substance use occasions in the past 30 days from Baseline to Post-treatment at 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Drug Abuse Screening Test (DAST-10) From Baseline to Post-treatment at 8 Weeks | 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. |
| Change in Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-treatment at 8 Weeks | Change from Baseline to Post-treatment at 8 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. |
| Change in Craving Ratings From Baseline to Post-treatment at 8 Weeks | Change from Baseline to Post-treatment at 8 weeks | A one-item, self-reported rating of craving intensity to use substances over the past 7 days. Score ranges is from 0-4, where a greater score indicates a more intense urge to use. |
| Change in Pain Ratings From Baseline to Post-treatment at 8 Weeks | Change from Baseline to Post-treatment at 8 Weeks | A one item, self-reported rating of pain. Scores range from 0-100 where higher scores indicate greater levels of pain. |
| Change in Patient Health Questionnaire-8 (PHQ-8) From Baseline to Post-treatment at 8 Weeks | Change from Baseline to Post-treatment at 8 weeks | Measure of depression. An 8-item self-report questionnaire that assesses the frequency and severity of depression symptoms. Total scores range from 0 to 24 where higher scores indicate greater levels of depression. |
| Change in Short Inventory of Problems - Alcohol and Drugs (SIP-AD) From Baseline to Post-treatment at 8 Weeks | Change from Baseline to Post-treatment at 8 weeks | Measure of substance use problems. The SIP-AD assesses substance use problems in the past 30 days. Total score consists of of the sum of all 15 items, ranging from 0-45, where greater scores indicate greater substance use problems. |
| Change in CAIR Pandemic Impact Questionnaire (CAIR-PIQ) From Baseline to Post-treatment at 8 Weeks | Change from Baseline to Post-treatment at 8 weeks | Assesses impact of the COVID-19 pandemic in terms of exposure to stressors, mental health impact, and growth. Possible total score range from 0-22, where greater scores are related to greater impact. |
| Client Satisfaction Questionnaire (CSQ) at Post-treatment at 8 Weeks | Post-treatment (8 weeks from Baseline) | 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. |
| Usage Rating Profile - Intervention (URPI)-Acceptability at Post-treatment at 8 Weeks | Post-treatment (8 weeks from Baseline) | Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Total scores range from 6-36, where greater scores indicate greater intervention acceptability. |
| Usage Rating Profile - Intervention (URPI)-Feasibility at Post-treatment at 8 Weeks | Post-treatment (8 weeks from Baseline) | Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Total scores range from 6-36, where greater scores indicate greater intervention feasibility. |
| Change in 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. Total scores range from 12-60, 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 in General Anxiety Disorder (GAD-7) From Baseline to Post-treatment at 8 Weeks | Change from Baseline to Post-treatment at 8 weeks | Measure of anxiety. A 7-item brief self-report measure used to assess the frequency and severity of anxious thoughts and behaviors over the past 2 weeks. Total score between 0-21, where higher scores indicate greater levels of anxiety. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| W-SUDs Woebot Substance Use Disorder: Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation. | 88 |
| Wait List Control Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study. | 92 |
| Total | 180 |
Baseline characteristics
| Characteristic | Wait List Control | Total | W-SUDs |
|---|---|---|---|
| Age, Continuous | 39.8 years STANDARD_DEVIATION 11.2 | 40.3 years STANDARD_DEVIATION 11.6 | 40.8 years STANDARD_DEVIATION 12.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 24 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 80 Participants | 156 Participants | 76 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 11 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 22 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 70 Participants | 140 Participants | 70 Participants |
| Sex: Female, Male Female | 59 Participants | 117 Participants | 58 Participants |
| Sex: Female, Male Male | 33 Participants | 63 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 88 | 0 / 92 |
| other Total, other adverse events | 0 / 88 | 0 / 92 |
| serious Total, serious adverse events | 0 / 88 | 1 / 92 |
Outcome results
Primary
Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks
Change in number of substance use occasions in the past 30 days from Baseline to Post-treatment at 8 weeks
Time frame: Change from Baseline to Post-treatment at 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| W-SUDs | Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks | -9.1 occasions | Standard Deviation 2 |
| Waitlist Control | Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks | -4.7 occasions | Standard Deviation 1 |
Secondary
Change in Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-treatment at 8 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.
Time frame: Change from Baseline to Post-treatment at 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| W-SUDs | Change in Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-treatment at 8 Weeks | 11.8 score on a scale | Standard Deviation 3.4 |
| Waitlist Control | Change in Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-treatment at 8 Weeks | 5.3 score on a scale | Standard Deviation 3.1 |
Secondary
Change in CAIR Pandemic Impact Questionnaire (CAIR-PIQ) From Baseline to Post-treatment at 8 Weeks
Assesses impact of the COVID-19 pandemic in terms of exposure to stressors, mental health impact, and growth. Possible total score range from 0-22, where greater scores are related to greater impact.
Time frame: Change from Baseline to Post-treatment at 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| W-SUDs | Change in CAIR Pandemic Impact Questionnaire (CAIR-PIQ) From Baseline to Post-treatment at 8 Weeks | -1.8 units on a scale | Standard Deviation 0.5 |
| Waitlist Control | Change in CAIR Pandemic Impact Questionnaire (CAIR-PIQ) From Baseline to Post-treatment at 8 Weeks | -1.4 units on a scale | Standard Deviation 0.5 |
Secondary
Change in Craving Ratings From Baseline to Post-treatment at 8 Weeks
A one-item, self-reported rating of craving intensity to use substances over the past 7 days. Score ranges is from 0-4, where a greater score indicates a more intense urge to use.
Time frame: Change from Baseline to Post-treatment at 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| W-SUDs | Change in Craving Ratings From Baseline to Post-treatment at 8 Weeks | -.5 scores on a scale | Standard Deviation 0.1 |
| Waitlist Control | Change in Craving Ratings From Baseline to Post-treatment at 8 Weeks | -.4 scores on a scale | Standard Deviation 0.1 |
Secondary
Change in Drug Abuse Screening Test (DAST-10) 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.
Time frame: Change from Baseline to Post-treatment at 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| W-SUDs | Change in Drug Abuse Screening Test (DAST-10) From Baseline to Post-treatment at 8 Weeks | 1.3 score on a scale | Standard Deviation 1.8 |
| Waitlist Control | Change in Drug Abuse Screening Test (DAST-10) From Baseline to Post-treatment at 8 Weeks | 2.2 score on a scale | Standard Deviation 2.1 |
Secondary
Change in General Anxiety Disorder (GAD-7) From Baseline to Post-treatment at 8 Weeks
Measure of anxiety. A 7-item brief self-report measure used to assess the frequency and severity of anxious thoughts and behaviors over the past 2 weeks. 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 |
|---|---|---|---|
| W-SUDs | Change in General Anxiety Disorder (GAD-7) From Baseline to Post-treatment at 8 Weeks | -1.6 units on a scale | Standard Deviation 0.6 |
| Waitlist Control | Change in General Anxiety Disorder (GAD-7) From Baseline to Post-treatment at 8 Weeks | -.7 units on a scale | Standard Deviation 0.5 |
Secondary
Change in Pain Ratings From Baseline to Post-treatment at 8 Weeks
A one item, self-reported rating of pain. Scores range from 0-100 where higher scores indicate greater levels of pain.
Time frame: Change from Baseline to Post-treatment at 8 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| W-SUDs | Change in Pain Ratings From Baseline to Post-treatment at 8 Weeks | -5.1 units on a scale | Standard Deviation 2.8 |
| Waitlist Control | Change in Pain Ratings From Baseline to Post-treatment at 8 Weeks | -.8 units on a scale | Standard Deviation 2.5 |
Secondary
Change in Patient Health Questionnaire-8 (PHQ-8) From Baseline to Post-treatment at 8 Weeks
Measure of depression. An 8-item self-report questionnaire that assesses the frequency and severity of depression symptoms. Total scores range from 0 to 24 where higher scores indicate greater levels of depression.
Time frame: Change from Baseline to Post-treatment at 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| W-SUDs | Change in Patient Health Questionnaire-8 (PHQ-8) From Baseline to Post-treatment at 8 Weeks | -1.6 units on a scale | Standard Deviation 0.6 |
| Waitlist Control | Change in Patient Health Questionnaire-8 (PHQ-8) From Baseline to Post-treatment at 8 Weeks | -1.7 units on a scale | Standard Deviation 0.6 |
Secondary
Change in Short Inventory of Problems - Alcohol and Drugs (SIP-AD) From Baseline to Post-treatment at 8 Weeks
Measure of substance use problems. The SIP-AD assesses substance use problems in the past 30 days. Total score consists of of the sum of all 15 items, ranging from 0-45, where greater scores indicate greater substance use problems.
Time frame: Change from Baseline to Post-treatment at 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| W-SUDs | Change in Short Inventory of Problems - Alcohol and Drugs (SIP-AD) From Baseline to Post-treatment at 8 Weeks | -5.3 score on a scale | Standard Deviation 1.1 |
| Waitlist Control | Change in Short Inventory of Problems - Alcohol and Drugs (SIP-AD) From Baseline to Post-treatment at 8 Weeks | -4.7 score on a scale | Standard Deviation 1 |
Secondary
Change in 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. Total scores range from 12-60, 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
Population: This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| W-SUDs | Change in Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks | 44.0 score on a scale | Standard Deviation 12.5 |
Secondary
Client Satisfaction Questionnaire (CSQ) at 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.
Time frame: Post-treatment (8 weeks from Baseline)
Population: This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| W-SUDs | Client Satisfaction Questionnaire (CSQ) at Post-treatment at 8 Weeks | 25.5 score on a scale | Standard Deviation 5 |
Secondary
Usage Rating Profile - Intervention (URPI)-Acceptability at Post-treatment at 8 Weeks
Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Total scores range from 6-36, where greater scores indicate greater intervention acceptability.
Time frame: Post-treatment (8 weeks from Baseline)
Population: This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| W-SUDs | Usage Rating Profile - Intervention (URPI)-Acceptability at Post-treatment at 8 Weeks | 29.0 score on a scale | Standard Deviation 4.8 |
Secondary
Usage Rating Profile - Intervention (URPI)-Feasibility at Post-treatment at 8 Weeks
Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Total scores range from 6-36, where greater scores indicate greater intervention feasibility.
Time frame: Post-treatment (8 weeks from Baseline)
Population: This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| W-SUDs | Usage Rating Profile - Intervention (URPI)-Feasibility at Post-treatment at 8 Weeks | 32.0 score on a scale | Standard Deviation 3.6 |