Evaluation of an integrated treatment to address smoking cessation and anxiety/depressive symptoms among people living with HIV: Study protocol for a randomized controlled trial

Background Interventions that target anxiety/depressive symptoms in the context of smoking treatment have shown promise irrespective of psychiatric diagnosis. Yet, these tailored treatments are largely absent for persons who smoke and are living with HIV (SLWH). Objective To evaluate a novel, smoking cessation intervention that addresses anxiety/depression and HIV-related health (QUIT) against a time-matched control (TMC) and a standard of care (SOC) condition. Methods SLWH (N = 180) will be recruited and enrolled from 3 medical clinics in Boston, MA, and Houston, TX. The trial will consist of a baseline assessment, a 10-week intervention/assessment period, and follow-up assessments, accounting for a total study duration of approximately 8 months. All participants will complete a baseline visit and a pre-randomization standardized psychoeducation visit, and will then be randomized to one of three conditions: QUIT, TMC, or SOC. QUIT and TMC will consist of nine 60-min, cognitive behavioral therapy-based, individual weekly counseling sessions using standard smoking cessation counseling; additionally, QUIT will target anxiety and depressive symptoms by addressing underlying mechanisms related to mood and quit difficulty. SOC participants will complete weekly self-report surveys for nine weeks. All participants will be encouraged to quit at Session 7 and will be offered nicotine replacement therapy to help. Conclusions QUIT is designed to improve smoking cessation in SLWH by addressing anxiety and depression and HIV-related health issues. If successful, the QUIT intervention would be ready for implementation and dissemination into “real-world” behavioral health and social service settings consistent with the four objectives outlined in NIDA's Strategic Plan.