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

Change in number of substance use occasions in the past 30 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

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 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

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.

Time frame: Change from Baseline to 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)

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.

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

Assessment of number of emails opened duration of study

Time frame: Baseline to Post-treatment at 8 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.

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 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.

Time frame: Baseline

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.

Time frame: Baseline and Post-treatment at 8 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).

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).

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.

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).

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.

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.

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 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.

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).

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

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.

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.

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

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.

Time frame: Difference between Mid-treatment at 4 weeks and Post-treatment at 8 weeks