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| ID | Type | Description | Link |
|---|---|---|---|
| 4R44DA048712-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Stanford University | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| W-SUDs | Experimental |
| |
| Wait List Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Woebot Substance Use Disorder | Other | Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from Baseline to Post-treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline to Post-treatment at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94306 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Waitlist Control | Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Wait List Control |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | occasions | Change from Baseline to Post-treatment at 8 weeks |
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Serious adverse events were assessed at post-treatment, 8 weeks from baseline.
Serious adverse events occurring during treatment were assessed for hospitalization related to substance use, suicide attempt, alcohol or drug overdose, and severe withdrawal (eg, delirium tremens). Positive endorsements were followed up with questions about the timing, diagnosis, and resolution. If additional details were needed to determine whether the event was study related, a team member reached out to the participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Systematic Assessment | Hospitalization for alcohol detoxification |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith J. Prochaska, PhD | Stanford Prevention Research Center, Department of Medicine, Stanford University | 650-724-3608 | jpro@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 30, 2022 | Oct 31, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 1, 2021 | Oct 31, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 19, 2020 | Oct 31, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D019973 | Alcohol-Related Disorders |
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| 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. | Change from Baseline to Post-treatment at 8 weeks |
| 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. | Change from Baseline to Post-treatment at 8 weeks |
| 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. | Change from Baseline to Post-treatment at 8 weeks |
| 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. | Change from Baseline to Post-treatment at 8 Weeks |
| 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. | Change from Baseline to Post-treatment at 8 weeks |
| 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. | Change from Baseline to Post-treatment at 8 weeks |
| 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. | Change from Baseline to Post-treatment at 8 weeks |
| 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. | Post-treatment (8 weeks from Baseline) |
| 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. | Post-treatment (8 weeks from Baseline) |
| 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. | Post-treatment (8 weeks from Baseline) |
| 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". | Change from Mid-treatment at 4 weeks to Post-treatment at 8 weeks |
Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to Post-treatment at 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to Post-treatment at 8 weeks |
|
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to Post-treatment at 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | scores on a scale | Change from Baseline to Post-treatment at 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline to Post-treatment at 8 Weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline to Post-treatment at 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline to Post-treatment at 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline to Post-treatment at 8 weeks |
|
|
|
| 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. | This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm. | Posted | Mean | Standard Deviation | score on a scale | Post-treatment (8 weeks from Baseline) |
|
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| 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. | This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm. | Posted | Mean | Standard Deviation | score on a scale | Post-treatment (8 weeks from Baseline) |
|
|
|
| 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. | This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm. | Posted | Mean | Standard Deviation | score on a scale | Post-treatment (8 weeks from Baseline) |
|
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| 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". | This measure was administered to the active intervention arm only; assessment not applicable for a waitlist control arm. | Posted | Mean | Standard Deviation | score on a scale | Change from Mid-treatment at 4 weeks to Post-treatment at 8 weeks |
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|
| 0 |
| 88 |
| 0 |
| 88 |
| 0 |
| 88 |
| EG001 | Wait List Control | Participants randomized to the waitlist control arm were provided access to W-SUDs after completing the 8-week study. | 0 | 92 | 1 | 92 | 0 | 92 |
|
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