Clinical trial NCT03904186: Effectiveness of an Integrated Treatment to Address Smoking Cessation and Anxiety/ Depression in People Living With HIV
Official title: Effectiveness of an Integrated Treatment to Address Smoking Cessation and Anxiety/ Depression in People Living With HIV
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Human Immunodeficiency Virus
Smoking Cessation
Smoking, Cigarette
Smoking
Anxiety
Depression
Nicotine Dependence
Keywords: Tobacco Use
Tobacco Use Disorder
Substance-Related Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
HIV
Anxious
Anxiety Symptoms
Depressive Symptoms
Quitting
Cognitive Behavioral Therapy
Anxiety Sensitivity
Distress Intolerance
Anhedonia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: The Fenway Institute
name: University of Texas at Austin
name: University of Houston
name: Baylor College of Medicine
name: Southern Methodist University
First posted: 2019-04-05
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Smokers living with HIV represent a major health disparity population in the United States and the world more generally. Major contributing factors to the maintenance and relapse of smoking among smokers living with HIV include increased exposure to multiple stressors associated with HIV, which often exacerbates anxiety/depression. In a previous project, the feasibility, acceptability, and initial efficacy of a 9-session, cognitive-behavioral-based intervention to address smoking cessation by reducing anxiety and depression via specific emotional vulnerabilities (anxiety sensitivity, distress tolerance, and anhedonia) was tested against an enhanced standard of care in a pilot randomized controlled trial (NCT01393301). It was found that when compared to a brief enhanced treatment as usual control, patients in the intervention achieved higher short-term and long-term smoking abstinence rates. In this project, the investigators seek to test this same intervention in a fully powered, 3-arm efficacy/effectiveness trial. The goal of this study is to randomize 180 smokers across three sites to test the efficacy/effectiveness of the intervention at increasing point prevalence abstinence by reducing anxiety and depression at a 1-month follow-up (the end of treatment timepoint/ approximately 1-month post quit day) and a 6-month follow-up (approximately 6-months post quit day).

Detailed description: Although the prevalence of smoking has declined over the past 50 years, large disparities in tobacco use remain across several subgroups, particularly disadvantaged and health compromised populations. In fact, the initiation and maintenance of smoking is twice as likely for individuals living with HIV than individuals not living with HIV. Smokers living with HIV represent a major health disparity population in the United States (US) and the world more generally, and their unique healthcare needs are not being adequately addressed. For people living with HIV, smoking is related to poorer survival, and among those who are adherent to their antiretroviral treatment regimens, smoking reduces life expectancy more than HIV. A major contributing factor to the maintenance and relapse of smoking among smokers living with HIV is the increased exposure to multiple stressors associated with HIV (e.g., compromised health status, stigma, cognitive impairment), which in turn, contributes to heightened anxiety/depression. Further, smokers living with HIV tend to rely on smoking to regulate their negative mood. As a result, smokers living with HIV require specialty care options that address their unique 'affective needs.' The proposed intervention is informed by the success of a recently completed research project (NCT01393301) in which the feasibility and acceptability of a 9-session, cognitive-behavioral therapy-based intervention to address smoking cessation and symptoms of anxiety and depression by targeting common processes underlying anxiety/depression (distress intolerance, anxiety sensitivity, anhedonia) was tested in a pilot randomized controlled trial (RCT) against an enhanced treatment as usual condition. Investigators named this intervention "QUIT". In the pilot RCT, smoking abstinence was significantly higher in the intervention than in the standard of care control at both the 1-month follow-up (the end-of-treatment timepoint) and the 6-month follow-up, and anxiety and depressive symptom severity was lower in the intervention condition than the control condition at the same timepoints. The present study seeks to conduct a fully powered, 3-arm hybrid efficacy/effectiveness trial, integrating resource utilization and cost-effectiveness analyses. The investigators propose to randomize 180 smokers living with HIV across three implementation sites. Two-fifths of the sample (n = 72) will be randomized to the QUIT intervention; two-fifths (n = 72) to an active, credible time-matched control (TM) and one-fifth (n = 36) to a standard-of-care (SOC) control. The primary outcomes of this study will be point prevalence abstinence at the 1-Month Follow-Up (end of treatment timepoint/ approximately 1-month post quit day) and 6-Month Follow-Up (approximately 6-months post quit day). Changes in anxiety/depressive symptom severity will also be examined, and cost-effectiveness analyses will be conducted.

Eligibility criteria: Inclusion Criteria:

* 18-79 years old
* Daily Smoker
* Motivated to quit smoking
* HIV-positive
* Capability and willingness to give written informed consent

Exclusion Criteria:

* Habitual use of tobacco products other than cigarettes
* Untreated or unstable psychiatric disorders
* Current smoking cessation treatment
* Cognitive behavioral therapy for anxiety within the past year
* Insufficient command of the English language

Primary outcomes:
measure: Short-Term Point Prevalence Smoking Abstinence
timeFrame: Time frame: 1-Month Follow-Up (end of treatment/approximately 1-month post quit date)
measure: Long-Term Point Prevalence Smoking Abstinence
timeFrame: Time frame: 6-Month Follow-Up (approximately 6-months post quit date)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Fenway Community Health
state: Massachusetts
city: Houston
country: United States
facility: Thomas Street Health Center
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Jasper Smits, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Houston
name: Michael Zvolensky, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garey L, Wirtz MR, Labbe AK, Zvolensky MJ, Smits JAJ, Giordano TP, Rosenfield D, Robbins GK, Levy DE, McKetchnie SM, Bell T, O'Cleirigh C. 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. Contemp Clin Trials. 2021 Jul;106:106420. doi: 10.1016/j.cct.2021.106420. Epub 2021 Apr 30.