Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Stanford University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Woebot-SUDs (W-SUDs) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline to Post-treatment at 8 weeks |
| 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. | Change from Baseline to Post-treatment at 8 weeks |
| 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 | Change from Baseline and Post-treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-treatment at 8 weeks |
| Usage Rating Profile Intervention (URPI) - Acceptability at Post-treatment at 8 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woebot Labs Inc | San Francisco | California | 94107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33755028 | Derived | Prochaska JJ, Vogel EA, Chieng A, Kendra M, Baiocchi M, Pajarito S, Robinson A. A Therapeutic Relational Agent for Reducing Problematic Substance Use (Woebot): Development and Usability Study. J Med Internet Res. 2021 Mar 23;23(3):e24850. doi: 10.2196/24850. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Survey questions: "How old are you?" and "What is your date of birth?" |
| 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 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. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to Post-treatment at 8 weeks |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith J Prochaska, PhD | Stanford Prevention Research Center, School of Medicine, Stanford University | 650-724-3608 | jpro@stanford.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 24, 2020 | Apr 28, 2022 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 23, 2021 | Aug 4, 2022 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 28, 2020 | May 18, 2020 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| Post-treatment at 8 weeks |
| 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. | Post-treatment at 8 weeks |
| 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". | Change from Mid-treatment at 4 weeks to Post-treatment at 8 weeks |
| 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. | Change from Baseline to Post-Treatment at 8 weeks |
| 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. | Change from Baseline to Post-Treatment at 8 weeks |
| 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. | Change from Baseline to Post-treatment at 8 weeks |
| Change Pain Rating From Baseline to Post-Treatment at 8 Weeks | Range from 0-100 (no pain to worst pain imaginable). | Change from Baseline to Post-treatment at 8 weeks |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Survey question: "What is your biological sex?" | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Survey question: "Are you Hispanic or Latinx?" | Count of Participants | Participants |
|
| Race (NIH/OMB) | Survey question following ethnicity question: "Additionally, what best defines your racial background? (select all that apply) | Count of Participants | Participants |
|
| Marital status | Survey question: "Which best describes you?" | Count of Participants | Participants |
|
| Employment status | Survey question: "Which category best describes you?" | Count of Participants | Participants |
|
| COVID-19 situation | Survey question: "What is your current situation with coronavirus/COVID-19? (check all that apply)" | Count of Participants | Participants |
|
| Lifetime psychiatric diagnoses | Survey question: "Has a doctor, nurse or other health professional ever told you that you had any of the following mental health conditions? Choose all that apply. If none, please select None." | Number | participants |
|
| Therapy experience | Participants asked about their current therapy situation | Number | participants |
|
| Patient Health Questionnaire-8 item depression | Measure of depression severity. Total score between 0-27, where higher scores indicate greater levels of depression. | Mean | Standard Deviation | units on a scale |
|
| General Anxiety Disorder-7 item anxiety | Measure of anxiety. Total score between 0-21, where higher scores indicate greater levels of anxiety. | Mean | Standard Deviation | units on a scale |
|
| Pain intensity in the past 7 days (possible range 0-100) | Survey questions about current (past 7 days) pain intensity | Mean | Standard Deviation | units on a scale |
|
| Pain interfere with normal work in the past 30 days | Survey question about how much a participant's pain has interfered with work during the past 4 weeks | Count of Participants | Participants |
|
| Primary substance | Participants are provided a list of substances (including alcohol) and asked which substance causes the most problems in their life. | Count of Participants | Participants |
|
| Past 30 days of substance use | Participants provided a list of substances (including alcohol) and asked how many days in the past 30 that they have used each substance | Count of Participants | Participants |
|
| Number of substance use occasions in the past 30 days | Mean | Standard Deviation | occassions |
|
| Alcohol Use Disorders Identification Test-Concise | Survey questions asking participants about their drinking. | The overall number of participants analyzed N=101, where n=24 men and n=77 women. | Mean | Standard Deviation | units on a scale |
|
| Drug Abuse Screening Test-10 item | 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. | Mean | Standard Deviation | units on a scale |
|
| Bothered by cravings in the past 7 days | Count of Participants | Participants |
|
| Brief Situational Confidence Questionnaire (BSCQ) | 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. | Mean | Standard Deviation | units on a scale |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to Post-treatment at 8 weeks |
|
|
|
| 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 | Posted | Mean | Standard Deviation | days | Change from Baseline and Post-treatment at 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Post-treatment at 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Post-treatment at 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Post-treatment at 8 weeks |
|
|
|
| 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". | Posted | Mean | Standard Deviation | score on a scale | Change from Mid-treatment at 4 weeks to Post-treatment at 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to Post-Treatment at 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to Post-Treatment at 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline to Post-treatment at 8 weeks |
|
|
|
| Secondary | Change Pain Rating From Baseline to Post-Treatment at 8 Weeks | Range from 0-100 (no pain to worst pain imaginable). | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to Post-treatment at 8 weeks |
|
|
|
| 0 |
| 101 |
| 1 |
| 101 |
| 0 |
| 101 |
Not provided
Not provided