The CAGE-AID has demonstrated validity, with high internal consistency in screening for problematic drug and alcohol use; a cutoff point of 2+ on the CAGE-AID has a sensitivity of 70% and specificity of 85% for identifying individuals with SUDs. Study exclusion criteria were current pregnancy, history of severe alcohol or drug-related medical problems , opioid overdose requiring Narcan , current opioid misuse without medication-assisted treatment, or attempted suicide within the past year. For this study, the target sample size was 50 participants; however, due to a high level of response and efficiency, enrollment was more than double our recruitment goal. Between March 27, 2020 and May 6, 2020, 3597 individuals were screened for study participation, with 3422 ineligible and 175 eligible individuals. Figure 1 shows the reasons for study exclusion, most frequently residing outside of the United States and endorsing fewer than 2 criteria on the CAGE-AID . Of the 175 eligible participants, 141 provided informed consent to participate in the study, of whom 128 completed the baseline survey.Among the 101 participants enrolled, 11reported previous use of the Woebot app. Described in detail previously, Woebot is an automated conversational agent that delivers CBT in the format of brief, daily text-based conversations. The Woebot program is deployed through its own native apps on both iPhone and Android smartphones or devices. The app on boarding process introduces the automated conversational agent, explains the intended use of the device, how data are treated,cannabis equipment and the limitations of the service .
The user experience is centered around mood tracking and goal-oriented, tailored conversations that can, depending on user input and choice, focus on CBT psycho education, application of psychotherapeutic skills for change , mindfulness exercises, gratitude journaling, and/or reflecting upon patterns and lessons already covered. Each interaction begins with a general inquiry about context and moodto ascertain affect in the moment. Additional therapeutic process-oriented features of Woebot include delivery of empathic responses with tailoring to users’ stated mood, goal setting with regular check-ins for maintaining accountability, a focus on motivation and engagement, and individualized weekly reports to foster reflection. Users become familiar with Woebot, which is a friendly, helpful character that is explicitly not a human or a therapist but rather a guided self-help coach. Daily push notifications prompt users to check in. We adapted W-SUDs, drawing upon motivational interviewing principles, mindfulness training, dialectical behavior therapy, and CBT for relapse prevention. Sample screenshots from the W-SUDs app are shown in Figure 2. In total, the W-SUDs intervention was developed as an 8-week program with tracking of mood, substance use craving, and pain, with over 50 psycho educational lessons and psychotherapeutic skills. CBT evidence-based, guided self-help treatments have ranged in length from 2 to 12 weeks, and the National Institutes for Clinical Excellence describes guided self-help as including 6 to 8 face-to-face sessions. Early responsiveness to SUD treatment is predictive of long-term outcomes, and brief addiction treatments are efficacious. Brief intervention can minimize potential dropout, a problem common to SUD treatment;therefore, we designed W-SUDs as an 8-week treatment. Woebot is not designed to address active suicidal ideation or overdose, and this was stated in the study informed consent. In addition, Woebot conversationally informs first-time users that it is not a crisis service. Woebot also has safety net detection that uses natural language processing algorithms to detect and flag several hundred possible harm-to-self phrases with 98% accuracy . Woebot detects crisis language and asks to confirm it with the user. If the user confirms, Woebot offers resources , carefully curated with expert consultation.
Woebot data indicate that users do not use Woebot for crisis management; approximately 6.3% trigger the safety net protocol, with 27% of those confirming that it is indeed a crisis when Woebot asks to confirm . W-SUDs, an automated conversational agent, was feasible to deliver, engaging, and acceptable and was associated with significant improvements pre- to post treatment in self-reported measures of substance use, confidence, craving, depression, and anxiety and in-app measures of craving. The W-SUDs app registration rate among those who completed the baseline survey was 78.9% , comparable with other successful mobile health interventions. As expected, the use of the W-SUDs app was highest early in treatment and declined over the 8 weeks. Study of engagement with digital health apps has been growing, with no consensus yet on ideal construct definitions. Simply reporting the number of messages or minutes spent on an app over time may undermine clarity and genuine understanding of the type and manifestation of app utilization related to clinical outcomes of interest. Further research in this area is warranted. The observed reductions from pre- to post treatment measures of depression and anxiety symptoms were consistent with a previous evaluation of Woebot conducted with college students self-identified as having symptoms of anxiety and depression. Furthermore, in this study, treatment-related reductions in depression and anxiety symptoms were associated with declines in problematic substance use. Declines in depressive symptoms observed from pre- to post treatment were greater among the participants in therapy. This study also examined working alliance, proposed to mediate clinical outcomes in traditional therapeutic settings. Traditionally, working alliance has been characterized as the cooperation and collaboration in the therapeutic relationship between the patient and the therapist. The role of working alliance in relationally based systems and digital therapeutics has been previously considered; the potential of alliance to mediate outcomes in Woebot should be further validated in future studies adequately powered to examine mediators of change.
Measures of physical pain did not change with the use of W-SUDs as reported in pre- and post treatment measures or within the app; however, the sample’s baseline ratings of pain intensity and pain interference were low. Although not a direct intervention target, pain was measured due to the potential for use of substances to self-treat physical pain and the possibility that pain may worsen if substance use was reduced,vertical grow shelf which was not observed here. Within-app lesson completion and content acceptability were high for the overall sample, although there was a wide range of use patterns. Most participants used all facets of the W-SUDs app: tracked their mood, cravings, and pain; completed on average over 7 psycho educational lessons; and used tools in the W-SUDs app. Only about half of the sample completed the post treatment assessment, with better retention among those screening higher on the CAGE-AID. That is, those with more severe substance use problems at the start of the study, and hence in greater need of the intervention, were more likely to complete the post treatment evaluation. None of the other measured variables distinguished those who did and did not complete the post treatment evaluation. This level of attrition is commensurate with other digital mental health solution trial attrition rates.By addressing problematic substance use, including but not limited to alcohol, the W-SUDs intervention supports and extends a growing body of literature on the use of automated conversational agents and other mobile apps to support behavioral health. A systematic review of mobile and web-based interventions targeting the reduction of problematic substance use found that most web-based interventions produced significant short-term improvements in at least one measure of problematic substance use. Mobile apps were less common than web-based interventions, with weaker evidence of efficacy and some indication of causing harm . However, mobile interventions can be efficacious. Electronic screening and brief intervention programs, which use mobile tools to screen for excessive alcohol use and deliver personalized feedback, have been found to effectively reduce alcohol consumption and alcohol-related problems. However, rigorous evaluation trials of digital interventions targeting non-alcohol substance use are limited. Furthermore, although a systematic review concluded that conversational agents showed preliminary efficacy in reducing psychological distress among adults with mental health concerns compared with inactive control conditions, this is the first published study of a conversational agent adapted for substance use. Study strengths include study enrollment being double the initial recruitment goal, reflecting interest in W-SUDs. Most participants reported lifetime psychiatric diagnoses, and approximately half of the participants endorsed current moderate-to-severe levels of depression or anxiety. W-SUDs was used on average twice per week during the 8-week program. From pre- to post treatment with W-SUDs, participants reported significant improvements in multiple measures of substance use and mood. The delivery modality of W-SUDs offered easy, immediate, and stigma-free access to emotional support and substance use recovery information, particularly relevant during a time of global physical distancing and sheltering in place.
More time spent at home, coupled with reduced access to in-person mental health care, may have increased enrollment and engagement with the app. Although further data on recruitment and enrollment are warranted, these early findings suggest that individuals with SUDs are indeed interested in obtaining support for this condition from a fully digitalized conversational agent. This study had a single-group design, and the outcomes were short term and limited to post treatment, thus limiting the strength of inferences that can be drawn. The sample was predominately female and identified as non-Hispanic White, and the majority were employed full-time. Non-Hispanic White participants reported higher program acceptability on 2 of the 4 measures compared with participants from other racial or ethnic groups. Future research on W-SUDs will use a randomized design, with longer follow-up, and focus on recruitment of a more diverse population to better inform racial or ethnic cultural programmatic tailoring, using quotas to ensure racial or ethnic diversity in sampling. Notably, although recruited from across the United States, nearly all participants were sheltering in place at the time of study enrollment due to the COVID-19 pandemic, which may have affected substance use patterns and mood as well as interest in a digital health intervention. Notably, however, alcohol sales in the United States increased during the COVID-19 pandemic. The primary outcomes of substance use, cravings, confidence, mood, and program acceptability were standard measures with demonstrated validity and reliability. The limitations were that all were self-reported, and acceptability measures were not open-ended or qualitative. Few participants were misusing opioids, likely due to study exclusion designed to mitigate risk, namely, the requirement of engagement with medication-assisted treatment and no history of opioid overdose requiring Narcan . Notably, nearly 1400 people with interest in a program for those with substance use concerns were excluded due to low severity on the CAGE-AID screener. Worth testing is the utility of digital health programs for early intervention on substance misuse that is sub-syndromal. Building upon the findings of this study, future research will evaluate W-SUDs in a randomized controlled trial with a more racially or ethnically diverse sample, balanced on sex and primary problematic substance of use; will employ greater strategies for study retention ; and will be conducted during a period with less restrictions on social contacts and physical mobility. Randomized controlled evaluations of conversational agent interventions relative to other treatment modalities are required. The COVID-19 pandemic, caused by the SARS-CoV-2 virus, took the world by surprise in early 2020 and resulted in unprecedented disruptions to normal life throughout the world as measures were put in place to control the spread of the deadly virus . Across North America, COVID-19 swept across the United States and Canada overwhelming health services and health infrastructure as cases exploded, hospitalizations exceeded capacity, and businesses and public programs like schools were forced to shut their doors, go online, or on hiatus . The physical and social impact was enormous – death rates grew exponentially and the healthcare system was pushed to exceed capacity in the face of enormous caseloads and a virus that spread rapidly . As schools, clinics, social venues, and otherwise non-essential businesses shut their doors, the most vulnerable in our society including those marginally housed, those experiencing substance use and/or those with mental health issues were even further marginalized as a result of lost services and support . Early in the pandemic, signs of increases in substance use raised concerns that substance use would skyrocket . Overdoses and particularly overdose deaths hit unprecedented levels and partially because of the reduced availability of emergency medical services .