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OpenTrials
Completed

NCT Number: NCT04974645

Pilot: Digital Therapeutic vs Education for the Management of Problematic Substance Use

Prior to launching a randomized controlled trial, this pilot study will investigate the feasibility and acceptability of the administration of a diagnostic interview and collection of a biomarker test, as well as engagement and preliminary efficacy with W-SUDs and the education arm, among a sample of adults who screen positive for problematic substance use.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, Palo Alto, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have a smartphone
  • Endorse a substance use concern
  • Be between 18 and 65 years of age
  • Be available and committed to engage with the Woebot app
  • Be literate in English.(This is required for inclusion because all materials will be in English).

Exclusion criteria

  • Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
  • Suicide attempt within the past year (12 months)
  • Symptoms of severe drug/alcohol history: History of delirium tremens; Experiencing hypertension, drenching sweats, seizures or confusion after stopping alcohol or drugs; Liver trouble (cirrhosis or hepatitis); Convulsions or GI bleeding due to drug/alcohol use
  • Opioid overdose within the past year (12 months)
  • Opioid misuse without medication-assisted treatment
  • Not residing in the U.S.
  • Ever used Woebot

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Number of Substance Use Occasions

    Time frame: Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks

    Change in number of substance use occasions in the past 30 days

Secondary outcomes

  1. Past Month Average Days Per Week of Drinking Alcohol

    Time frame: Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks

    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).

  2. Past Month Average Standard Drinks in a Day

    Time frame: Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks

    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).

  3. Past Month Number of Binge Days

    Time frame: Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks

    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).

  4. Past Month Average Standard Drinks in a Week

    Time frame: Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks

    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.

  5. Short Inventory of Problems- Alcohol and Drugs (SIP-AD)

    Time frame: Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks

    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.

  6. Craving Ratings

    Time frame: Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks

    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.

  7. Working Alliance Inventory (WAI-SR)

    Time frame: Difference between Mid-treatment at 4 weeks and 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. 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".

  8. Stanford Presenteeism Scale (SPS-6)

    Time frame: Change from Baseline to Post-treatment at 8 weeks

    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.

  9. Thoughts About Abstinence (TAA)

    Time frame: Change from Baseline to Post-treatment at 8 weeks

    Modified for alcohol and substances. 5-item questionnaire assessing desire to quit, expected success at quitting, expected difficulty of quitting, and confidence in ability to quit. Each item 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).

  10. CAIR Pandemic Impact Questionnaire (C-PIQ)

    Time frame: 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. Exposure domain total scores range from 0-15, with higher scores indicating greater exposure. Impact domain total scores range from 0-23, where greater scores are related to greater impact.

  11. Patient Health Questionnaire (PHQ-8)

    Time frame: Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks

    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.

  12. Generalized Anxiety Disorder (GAD-7)

    Time frame: Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks

    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.

  13. Brief Situational Confidence Questionnaire (BSCQ)

    Time frame: Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 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.

  14. Usage Rating Profile - Intervention (URPI)-Acceptability

    Time frame: Post-treatment (8 weeks from baseline)

    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.

  15. Usage Rating Profile Intervention - Intervention (URPI)-Feasibility

    Time frame: 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). 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.

  16. Client Satisfaction Questionnaire (CSQ)

    Time frame: 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.

  17. Number of Participants Indicating Substance Use

    Time frame: Baseline

    The alcohol use disorder and substance use disorder (non-alcohol) modules of the Mini-International Neuropsychiatric Interview (MINI) was used to assess a alcohol and substance use diagnosis.

  18. Number of Participants Providing PEth Sample Phosphatidylethanol (PEth)

    Time frame: Baseline and Post-treatment at 8 weeks

    Phosphatidylethanol (PEth) is an alcohol biomarker, where a positive result is an indication of alcohol exposure during the 2-4 weeks prior to specimen collection. Participants were asked to complete PEth tests at Baseline and Post-treatment at 8 weeks.

  19. Engagement With Control Condition

    Time frame: Baseline to Post-treatment at 8 weeks

    Assessment of number of emails opened duration of study

Sponsors and collaborators

Lead sponsor

Woebot Health

Industry

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • Stanford University

Registry information

Official study title

Pilot: Randomized Controlled Trial of an Digital Therapeutic Versus Education for the Management of Problematic Substance Use

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 23, 2021
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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