TY - JOUR AU - Dahne, Jennifer AU - Wahlquist, Amy E AU - Kustanowitz, Jacob AU - Natale, Noelle AU - Fahey, Margaret AU - Graboyes, Evan M AU - Diaz, Vanessa A AU - Carpenter, Matthew J PY - 2023 DA - 2023/11/1 TI - Behavioral Activation–Based Digital Smoking Cessation Intervention for Individuals With Depressive Symptoms: Randomized Clinical Trial JO - J Med Internet Res SP - e49809 VL - 25 KW - smoking cessation KW - depression KW - digital health KW - decentralized trial KW - mental health KW - depressive KW - RCT KW - randomized KW - controlled trial KW - smoking KW - smoke KW - smoker KW - quit KW - quitting KW - cessation KW - eHealth KW - e-health KW - NRT KW - nicotine KW - mobile health KW - mHealth KW - app KW - apps KW - application KW - applications AB - Background: Depression is common among adults who smoke cigarettes. Existing depression-specific cessation interventions have limited reach and are unlikely to improve smoking prevalence rates among this large subgroup of smokers. Objective: This study aimed to determine whether a mobile app–based intervention tailored for depression paired with a mailed sample of nicotine replacement therapy (NRT) is efficacious for treating depression and promoting smoking cessation. Methods: A 2-arm nationwide remote randomized clinical trial was conducted in the United States. Adults (N=150) with elevated depressive symptoms (Patient Health Questionnaire-8≥10) who smoked were enrolled. The mobile app (“Goal2Quit”) provided behavioral strategies for treating depression and quitting smoking based on Behavioral Activation Treatment for Depression. Goal2Quit participants also received a 2-week sample of combination NRT. Treatment as usual participants received a self-help booklet for quitting smoking that was not tailored for depression. Primary end points included Goal2Quit usability, change in depression (Beck Depression Inventory-II) across 12 weeks, and smoking cessation including reduction in cigarettes per day, incidence of 24-hour quit attempts, floating abstinence, and 7-day point prevalence abstinence (PPA). Results: In total, 150 participants were enrolled between June 25, 2020, and February 23, 2022, of which 80 were female (53.3%) and the mean age was 38.4 (SD 10.3) years. At baseline, participants on average reported moderate depressive symptoms and smoked a mean of 14.7 (SD 7.5) cigarettes per day. Goal2Quit usability was strong with a mean usability rating on the System Usability Scale of 78.5 (SD 16.9), with 70% scoring above the ≥68 cutoff for above-average usability. Retention data for app use were generally strong immediately following trial enrollment and declined in subsequent weeks. Those who received Goal2Quit and the NRT sample reported lower mean depressive symptoms over the trial duration as compared to treatment as usual (difference of mean 3.72, SE 1.37 points less; P=.01). Across time points, all cessation outcomes favored Goal2Quit. Regarding abstinence, Goal2Quit participants reported significantly higher rates of 7-day PPA at weeks 4 (11% vs 0%; P=.02), 8 (7-day PPA: 12% vs 0%; P=.02), and 12 (16% vs 2%; P=.02). Conclusions: A mobile app intervention tailored for depression paired with a sample of NRT was effective for depression treatment and smoking cessation. Findings support the utility of this intervention approach for addressing the currently unmet public health treatment need for tailored, scalable depression-specific cessation treatments. Trial Registration: ClinicalTrials.gov NCT03837379; https://clinicaltrials.gov/ct2/show/NCT03837379 SN - 1438-8871 UR - https://www.jmir.org/2023/1/e49809 UR - https://doi.org/10.2196/49809 UR - http://www.ncbi.nlm.nih.gov/pubmed/37910157 DO - 10.2196/49809 ID - info:doi/10.2196/49809 ER -