Study protocol for approach bias retraining for nicotine addiction among dual combustible and electronic cigarette users.

BACKGROUND: Electronic cigarette (ECIG) use has become a popular method for nicotine delivery. Combustible cigarette (CC) cessation or reduction are the primary reasons for ECIG uptake among adults. Yet, most CC smokers who initiate ECIG use do not fully transition from CC to ECIG, despite intending to quit CC completely. Retraining approach bias, or the approach action tendency toward stimuli related to the substance of interest, has been effective in alcohol and CC use treatments. However, approach bias retraining for both CC and (ECIG) users has not been explored. Therefore, the objective of the study is to evaluate the initial efficacy of approach bias retraining among dual CC and ECIG users. METHODS: Eligible dual CC/ECIG using adults (N = 90) will complete a phone-screener, baseline assessment, 4 treatment sessions over 2 weeks, ecological momentary assessments (EMAs) post-intervention, and follow-ups at 4- and 6-week post-intervention. Participants will be assigned to one of three conditions at baseline: (1) CC + ECIG retraining; (2) CC only retraining; and (3) sham retraining. Participants will engage in a self-guided quit attempt to abstain from all nicotine products starting at treatment session 4. CONCLUSIONS: The study may lead to a more effective treatment for at-risk nicotine users while simultaneously isolating explanatory mechanisms. The findings should guide advances in the theoretical conceptualization of nicotine addiction for dual users and mechanisms involved in maintaining and abstaining from CC and ECIG, and provide initial effect size data for a brief intervention, thus providing necessary data for a large-scale follow-up trial. Clinical Trials ID: NCT05306158.

A Smartphone-Based Intervention for Anxiety and Depression in Racially and Ethnically Diverse Adults (EASE): Protocol for a Randomized Controlled Trial.

BACKGROUND: Clear health disparities have emerged in the rates of COVID-19 exposure, hospitalization, and death among Black, Hispanic, and American Indian (BHAI) individuals, relative to non-Hispanic White (NHW) individuals. BHAI populations have been disproportionately affected by lower behavioral health access and heightened negative mental health outcomes during the pandemic. OBJECTIVE: This project directly addresses health disparities in access to behavioral health care during the COVID-19 pandemic among BHAI populations via an adaptation of the established, initially validated, low-cost, mobile app Easing Anxiety Sensitivity for Everyone (EASE) among individuals with symptoms of elevated anxiety or depression or both. METHODS: The EASE trial is a 2-arm, prospective, randomized, blinded-assessor study with intention-to-treat analysis. Participants (N=800; n=200, 25%, Black; n=200, 25%, Hispanic; n=200, 25%, American Indian; and n=200, 25%, NHW) are randomized to receive either EASE or an active comparison condition for anxiety and depression. Participants compete an online prescreener, an enrollment call to provide informed consent, a baseline survey, a 6-month intervention period, and 3- and 6-month postbaseline assessments. Select participants also complete a 3- and 6-month postbaseline qualitative interview via phone or an online platform (eg, Zoom). Participants complete 2 scheduled daily ecological momentary assessments (EMAs) during the 6-month study period. These twice-daily EMAs guide a just-in-time approach to immediate, personalized behavioral health care. RESULTS: Outcomes include reductions in anxiety and depressive symptoms and functional impairment at 3 and 6 months postrandomization. We also will examine putative mechanisms (eg, anxiety sensitivity [AS] and COVID-19-specific stress and fear) of the intervention effects. Further, as treatment effects may differ across sociocultural factors, perceived discrimination, social support, and socioeconomic status (SES) will be evaluated as potential moderators of treatment effects on the primary outcomes. Process evaluation using data collected during the study, as well as individual interviews with participants, will complement quantitative data. CONCLUSIONS: Data from this efficacy trial will determine whether EASE successfully improves symptoms of anxiety and depression and whether these improvements outperform an active comparison control app. If successful, findings from this study have the potential to decrease anxiety and depression symptoms among vulnerable populations determined to be most at risk of exacerbated, long-lasting negative health sequelae. Data from this study may be used to support an implementation and dissemination trial of EASE within real-world behavioral health and social service settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT05074693; https://clinicaltrials.gov/ct2/show/NCT05074693. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40713.