Developing and Evaluating a Digital Therapy for Comorbid Anxiety Disorders and Alcohol/Cannabis Use Disorders

About This Grant

Abstract Comorbid anxiety disorders and substance use disorders (SUD) are associated with poor clinical and functional outcomes. Identifying solutions for the treatment of this comorbidity is critical to improving public health. Theoretical models, clinical trials, and policy support the use of treatments that simultaneously address both problems in clinically meaningful ways, as opposed to separate treatments for each problem, which can lead to poorer clinical outcomes and barriers to care. Digital therapeutics specifically designed for those with comorbid anxiety disorders and SUD are lacking and yet have the potential to increase access to evidence-based behavioral treatment that is currently inaccessible. Although digital interventions exist separately for anxiety disorders and for SUD, none have been developed to address the unique needs of the prevalent and high-risk population of those with comorbid anxiety/SUD. This study builds upon Dr. Wolitzky-Taylor’s innovative program of work in developing and evaluating CBT protocols for this comorbidity by adapting her treatment model to a digital platform. This study aims to develop and evaluate the preliminary efficacy of a digital therapeutic for comorbid anxiety/SUD, Anxiety Management Treatment for SUD (AMT/SUD). As a first step, although the intervention is framed transdiagnostically and relevant across the anxiety and substance use disorders, the target population will be those with mild to moderate cannabis and/or alcohol use disorder, as digital therapy is an appropriate primary modality for this SUD population. First, an iterative, human-centered design process will be used to develop the mobile application-based intervention. This will include a series of focus groups to improve upon a prototype of the application, development of the application, and a small open trial (n=8) to assess for usability and to identify and address any issues prior to the randomized clinical trial (RCT). Next, a pilot RCT will be conducted with adults (N=60) with comorbid anxiety disorders and SUD (recruited from the community and several clinics who serve this population but do not provide integrated care for both problems). Participants will be randomized to either (a) “AMT/SUD”, in which they will engage with the digital therapy (which will include the option for on-demand clinical coaching on the digital content) for 12 weeks, or (b) “SUD-track”, an active control condition in which participants will be instructed to engage with Quitzilla, a publicly available substance use (and other behavior) tracking/monitoring app with motivational content, for 12 weeks. Participants will be assessed on treatment acceptability at post-treatment, and on anxiety and substance use outcomes at baseline, and 3- and 6-mo follow-ups. Following the RCT, additional patient focus groups will be conducted to inform additional refinements to the AMT/SUD mobile application-based CBT program. This digital therapeutic has the potential to make a substantial public health impact.