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. 2021 Jul:106:106420.
doi: 10.1016/j.cct.2021.106420. Epub 2021 Apr 30.

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

Lorra Garey  1 , Megan R Wirtz  2 , Allison K Labbe  3 , Michael J Zvolensky  1 , Jasper A J Smits  4 , Thomas P Giordano  5 , David Rosenfield  6 , Gregory K Robbins  7 , Douglas E Levy  8 , Samantha M McKetchnie  9 , Tanisha Bell  10 , Conall O'Cleirigh  11
Affiliations

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

Lorra Garey et al. Contemp Clin Trials. 2021 Jul.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT03904186.

Keywords: Anxiety; Depression; Efficacy/effectiveness; HIV; Psychosocial treatment; Smoking cessation.

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Figures

Figure 1.
Figure 1.
Participant Flowchart
Figure 2.
Figure 2.
Mediation Model.
See this image and copyright information in PMC

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