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| Name | Class |
|---|---|
| Stanford University | OTHER |
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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.
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,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| W-SUDs | Experimental | 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. |
|
| Digitally-delivered Psychoeducation | Other | Psychoeducation delivers weekly fact sheets that include information on:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| W-SUDs | Device | Woebot (W-SUDs) 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 | Change in number of substance use occasions in the past 30 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline to Post-treatment at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith Prochaska, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42035882 | Derived | Prochaska JJ, Wang M, Chieng A, Moore J, Vogel EA, Baiocchi M, Pajarito S, Pirner MC, Bullard L, Darcy A, Robinson A. A relational agent for treating substance use in adults: A randomized controlled trial with a psychoeducational comparator. J Subst Use Addict Treat. 2026 Sep;188:209993. doi: 10.1016/j.josat.2026.209993. Epub 2026 Apr 24. | |
| 40548528 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Digitally-delivered Psychoeducation | Psychoeducation delivers weekly fact sheets that include information on:
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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change in number of substance use occasions in the past 30 days | Posted | Mean | Standard Deviation | 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 |
|
Serious adverse events were assessed at post-treatment and follow-up at 8-weeks and 12-weeks from baseline, respectively.
Serious adverse events occurring during treatment were assessed for hospitalization related to substance use, suicide attempt, alcohol or drug overdose, and severe withdrawal (e.g., 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 (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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith J. Prochaska, PhD, MPH | Stanford Prevention Research Center, Department of Medicine, Stanford | 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 | Mar 17, 2023 | Aug 27, 2024 | Prot_008.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 17, 2023 | Nov 28, 2023 | SAP_009.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 17, 2023 | Mar 28, 2023 | ICF_007.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Digitally-delivered Psychoeducation | Other | 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. |
|
| 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". | Post-treatment at 8 weeks |
| 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. | Change from Baseline to Post-treatment at 8 weeks |
| 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. | Change from Baseline to Post-treatment at 8 weeks |
| 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. | Baseline and Post-treatment at 8 weeks |
| 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. | Post-treatment at 8 weeks |
| 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. | Post-treatment at 8 weeks |
| 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. | Post-treatment at 8 weeks |
| 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. | 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 |
| 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. | 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 |
| 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. | 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 |
| 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. | 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 |
| 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. | 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 |
| 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). | 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 |
| 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. | 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 |
| Moore JB, Chieng A, Pirner MC, Pajarito S, Vogel EA, Bowdring MA, Bullard L, Robinson A, Prochaska JJ. Mitigating fraud in a fully decentralized clinical trial of a digital health intervention. Ann Behav Med. 2025 Jan 4;59(1):kaaf047. doi: 10.1093/abm/kaaf047. |
| 36813084 | Derived | Prochaska JJ, Vogel EA, Chieng A, Baiocchi M, Pajarito S, Pirner M, Darcy A, Robinson A. A relational agent for treating substance use in adults: Protocol for a randomized controlled trial with a psychoeducational comparator. Contemp Clin Trials. 2023 Apr;127:107125. doi: 10.1016/j.cct.2023.107125. Epub 2023 Feb 20. |
| BG001 | Digitally-delivered Psychoeducation | Psychoeducation delivers weekly fact sheets that include information on:
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gender | Count of Participants | Participants |
|
| Sexual Orientation | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Educational Degree | Count of Participants | Participants |
|
| Employment Status | Count of Participants | Participants |
|
| Disability Status | Count of Participants | Participants |
|
| Insurance Status | Count of Participants | Participants |
|
| Lifetime Mental Health Condition | Number | participants |
|
| Prior Therapy Experience | Count of Participants | Participants |
|
| Psychiatric Medications | Count of Participants | Participants |
|
| Past 30 Day SUD Treatment | Count of Participants | Participants |
|
| Past 30 Day Medication Use for SUD Treatment | Count of Participants | Participants |
|
| Primary, Secondary, or Tertiary Problematic Substance | Number | participants |
|
| OG001 | Digitally-delivered Psychoeducation | Psychoeducation delivers weekly fact sheets that include information on:
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. |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to Post-treatment at 8 weeks |
|
|
|
| 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". | Number analyzed for each subscale differs from the overall number analyzed due to missingness. | Posted | Mean | Standard Deviation | score on a scale | Post-treatment at 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to Post-treatment at 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to Post-treatment at 8 weeks |
|
|
|
| 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. | Number analyzed in categories reported at 8 weeks differs from overall number analyzed due to data missingness. | Posted | Number | participants | Baseline and Post-treatment at 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Post-treatment at 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Post-treatment at 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Post-treatment at 8 weeks |
|
|
|
| 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. | Number analyzed for each timepoint differs from the overall number analyzed due to missingness. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
| 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. | Number analyzed for each timepoint differs from the overall number analyzed due to missingness. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
| 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. | Number analyzed for each timepoint differs from the overall number analyzed due to missingness. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
| 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. | Number analyzed for each timepoint differs from the overall number analyzed due to missingness. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
| 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). | Number analyzed for each timepoint differs from the overall number analyzed due to missingness. | Posted | Mean | Standard Deviation | 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 |
|
|
|
| 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. | Number analyzed for each timepoint differs from the overall number analyzed due to missingness. | Posted | Mean | Standard Deviation | Drinks per 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 |
|
|
|
| 0 |
| 107 |
| 0 |
| 107 |
| 0 |
| 107 |
| EG001 | Digitally-delivered Psychoeducation | Psychoeducation delivers weekly fact sheets that include information on:
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. | 0 | 95 | 0 | 95 | 0 | 95 |
Not provided
Not provided
|
| Bond |
|
|
| Expected difficulty of quitting |
|
| Controlled use (Baseline) |
|
|
| Short-term abstinence (Baseline) |
|
|
| Occasional use when there is urge (Baseline) |
|
|
| Quit, but might slip (Baseline) |
|
|
| Quit forever (Baseline) |
|
|
| Other (Baseline) |
|
|
| No goal (8 weeks) |
|
|
| Controlled use (8 weeks) |
|
|
| Short-term abstinence, then decide about continued use (8 weeks) |
|
|
| Occasional use when there is urge (8 weeks) |
|
|
| Quit, but might slip (8 weeks) |
|
|
| Quit forever (8 weeks) |
|
|
| Other (8 weeks) |
|
|
| Prefer not to answer (8 weeks) |
|
|
| Post-treatment at 8 weeks |
|
|
| Follow-up at 12 weeks |
|
|
| Post-treatment at 8 weeks |
|
|
| Follow-up at 12 weeks |
|
|
| Post-treatment at 8 weeks |
|
|
| Follow-up at 12 weeks |
|
|
| Post-treatment at 8 weeks |
|
|
| Follow-up at 12 weeks |
|
|
| Follow-up at 12 weeks |
|
| Post-treatment at 8 weeks |
|
|
| Follow-up at 12 weeks |
|
|
| Post-treatment at 8 weeks |
|
|
| Follow-up at 12 weeks |
|
|