Dataset Information

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.

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.

SUBMITTER: Garey L

PROVIDER: S-EPMC10080995 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature

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Publications

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.

Garey Lorra L Wirtz Megan R MR Labbe Allison K AK Zvolensky Michael J MJ Smits Jasper A J JAJ Giordano Thomas P TP Rosenfield David D Robbins Gregory K GK Levy Douglas E DE McKetchnie Samantha M SM Bell Tanisha T O'Cleirigh Conall C

Contemporary clinical trials 20210430

<h4>Background</h4>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).<h4>Objective</h4>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.<h4>Methods</h4>SLWH ...[more]

PMID: 33933667

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Project description:ObjectiveAmong people living with HIV, cigarette smoking rates are higher than among the general population, and anxiety, depression, and their disorders are common and associated with smoking and poorer outcomes during cessation. This study evaluated the efficacy of an integrated smoking cessation intervention, developed to target anxiety, depression, and smoking cessation concurrently among people living with HIV.MethodSmokers living with HIV who reported at least moderate motivation to quit smoking were randomized into a novel 9-week integrated intervention (QUIT), consisting of 1 psychoeducation (prerandomization) session and 9 weekly 1-hour sessions of cognitive behavioral therapy for smoking cessation and anxiety/depression plus nicotine replacement therapy, or a 9-week enhanced standard smoking intervention (ETAU), consisting of 1 psychoeducation session (prerandomization) and 4 brief weekly check-in sessions plus nicotine replacement therapy. All were instructed to make a quit attempt at week 6.ResultsSeventy-two participants were enrolled, and 53 were randomized. 41/53 participants completed the active treatment phase of the study. 7-day point-prevalence abstinence, verified with expired carbon monoxide, was significantly higher among those in the integrated intervention than those in the enhanced standard intervention both end-of-treatment {[MQUIT = 59%, METAU = 9%; b = 5.60, 95% confidence interval: (2.64 to 8.56), t(332) = 3.72, P < 0.001]} and 6-months post-quit date {[MQUIT = 46%, METAU = 5%; b = 7.69, 95% confidence interval: (4.60 to 10.78), t(332) = 4.90, P < 0.001]}. Consideration of patterns of missingness did not alter the significance of these findings.ConclusionsThe integrated intervention was associated with substantially higher short-term and long-term abstinence rates than the enhanced standard intervention. These data provide promising initial evidence supporting the benefits of an integrated anxiety-depression/smoking cessation program specifically tailored for people living with HIV.

Project description:ImportanceLung cancer has become a leading cause of death among people living with human immunodeficiency virus (HIV) (PLWH). Over 40% of PLWH in the United States smoke cigarettes; HIV independently increases the risk of lung cancer.ObjectiveTo project cumulative lung cancer mortality by smoking exposure among PLWH in care.DesignUsing a validated microsimulation model of HIV, we applied standard demographic data and recent HIV/AIDS epidemiology statistics with specific details on smoking exposure, combining smoking status (current, former, or never) and intensity (heavy, moderate, or light). We stratified reported mortality rates attributable to lung cancer and other non-AIDS-related causes by smoking exposure and accounted for an HIV-conferred independent risk of lung cancer. Lung cancer mortality risk ratios (vs never smokers) for male and female current moderate smokers were 23.6 and 24.2, respectively, and for those who quit smoking at age 40 years were 4.3 and 4.5. In sensitivity analyses, we accounted for nonadherence to antiretroviral therapy (ART) and for a range of HIV-conferred risks of death from lung cancer and from other non-AIDS-related diseases (eg, cardiovascular disease).Main outcomes and measuresCumulative lung cancer mortality by age 80 years (stratified by sex, age at entry to HIV care, and smoking exposure); total expected lung cancer deaths, accounting for nonadherence to ART.ResultsAmong 40-year-old men with HIV, estimated cumulative lung cancer mortality for heavy, moderate, and light smokers who continued to smoke was 28.9%, 23.0%, and 18.8%, respectively; for those who quit smoking at age 40 years, it was 7.9%, 6.1%, and 4.3%; and for never smokers, it was 1.6%. Among women, the corresponding mortality for current smokers was 27.8%, 20.9%, and 16.6%; for former smokers, it was 7.5%, 5.2%, and 3.7%; and for never smokers, it was 1.2%. ART-adherent individuals who continued to smoke were 6 to 13 times more likely to die from lung cancer than from traditional AIDS-related causes, depending on sex and smoking intensity. Due to greater AIDS-related mortality risks, individuals with incomplete ART adherence had higher overall mortality but lower lung cancer mortality. Applying model projections to the approximately 644 200 PLWH aged 20 to 64 in care in the United States, 59 900 (9.3%) are expected to die from lung cancer if smoking habits do not change.Conclusions and relevanceThose PLWH who adhere to ART but smoke are substantially more likely to die from lung cancer than from AIDS-related causes.

Project description:BackgroundThe prevalence of smoking among people living with HIV (PLHIV) is higher than that reported in the general population, and it is a significant risk factor for noncommunicable diseases in this group. Mobile phone interventions to promote healthier behaviors (mobile health, mHealth) have the potential to reach a large number of people at a low cost. It has been hypothesized that mHealth interventions may not be as effective as face-to-face strategies in achieving smoking cessation, but there is no systematic evidence to support this, especially among PLHIV.ObjectiveThis study aimed to compare two modes of intervention delivery (mHealth vs face-to-face) for smoking cessation among PLHIV.MethodsLiterature on randomized controlled trials (RCTs) investigating effects of mHealth or face-to-face intervention strategies on short-term (4 weeks to <6 months) and long-term (≥6 months) smoking abstinence among PLHIV was sought. We systematically reviewed relevant RCTs and conducted pairwise meta-analyses to estimate relative treatment effects of mHealth and face-to-face interventions using standard care as comparison. Given the absence of head-to-head trials comparing mHealth with face-to-face interventions, we performed adjusted indirect comparison meta-analyses to compare these interventions.ResultsA total of 10 studies involving 1772 PLHIV met the inclusion criteria. The average age of the study population was 45 years, and women comprised about 37%. In the short term, mHealth-delivered interventions were significantly more efficacious in increasing smoking cessation than no intervention control (risk ratio, RR, 2.81, 95% CI 1.44-5.49; n=726) and face-to-face interventions (RR 2.31, 95% CI 1.13-4.72; n=726). In the short term, face-to-face interventions were no more effective than no intervention in increasing smoking cessation (RR 1.22, 95% CI 0.94-1.58; n=1144). In terms of achieving long-term results among PLHIV, there was no significant difference in the rates of smoking cessation between those who received mHealth-delivered interventions, face-to-face interventions, or no intervention. Trial sequential analysis showed that only 15.16% (726/1304) and 5.56% (632/11,364) of the required information sizes were accrued to accept or reject a 25% relative risk reduction for short- and long-term smoking cessation treatment effects. In addition, sequential monitoring boundaries were not crossed, indicating that the cumulative evidence may be unreliable and inconclusive.ConclusionsCompared with face-to-face interventions, mHealth-delivered interventions can better increase smoking cessation rate in the short term. The evidence that mHealth increases smoking cessation rate in the short term is encouraging but not sufficient to allow a definitive conclusion presently. Future research should focus on strategies for sustaining smoking cessation treatment effects among PLHIV in the long term.

Dataset Information

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

Objective

Methods

Conclusions

Publications

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.

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