Effectiveness of an Integrated Treatment to Address Smoking Cessation and Anxiety/ Depression in People Living With HIV

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).

Study Overview

• Status: Recruiting
• Conditions: Depression; Smoking; Smoking Cessation; Anxiety; Nicotine Dependence; Human Immunodeficiency Virus; Smoking, Cigarette
• Intervention / Treatment: Behavioral: QUIT; Behavioral: Time-Matched Control (TM)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Conall M O'Cleirigh, PhD; Phone Number: 617-643-0385; Email: cocleirigh@mgh.harvard.edu
• Study Contact Backup: Name: Samantha M McKetchnie, MSW; Phone Number: 617-724-9944; Email: smarquez1@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Samantha M McKetchnie, MSW; Phone Number: 617-643-0385; Email: smarquez1@mgh.harvard.edu
      • Principal Investigator: Conall O'Cleirigh, Ph.D.
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Fenway Community Health
      • Contact: Samantha M McKetchnie, MSW; Phone Number: 617-927-6465; Email: smarquezmcketchnie@fenwayhealth.org
      • Principal Investigator: Conall O'Cleirigh, PhD
  • Texas
    • Houston, Texas, United States, 77009
      • Recruiting
      • Thomas Street Health Center
      • Contact: Denise Flores; Phone Number: 713-873-4526; Email: Denise.Flores@bcm.edu
      • Principal Investigator: Thomas Giordano, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QUIT Treatment for Smoking Cessation and Distress Tolerance; Participants in this intervention arm will receive a Cognitive-Behavioral therapy-based intervention for smoking cessation in people living with HIV.	Behavioral: QUIT; QUIT is a transdiagnostic Cognitive Behavioral Therapy-based smoking cessation protocol designed to address distress intolerance, anxiety sensitivity, and anhedonia in people living with HIV who smoke. QUIT is delivered in 9 60-minute individual weekly sessions over a 10-week period. Sessions are active, with treatment components practiced within and outside of the session. Participants will also receive the transdermal nicotine patch for 8 weeks, starting when they attempt to quit smoking during week 7 of the study.
Active Comparator: Time and Intensity-Match Control; Participants in this control arm will receive an intervention matched in time and intensity with the experimental arm.	Behavioral: Time-Matched Control (TM); Participants will receive a standard smoking cessation treatment, based on the clinical practice guidelines from the U.S. Department of Health and Human Services, Treating Tobacco Use and Dependence. Treatment will be delivered in nine, 60-minute sessions over a ten-week period. The treatment is based on a treatment protocol developed and used previously by Dr. Zvolensky. Because clinical guidelines recommend that all smokers attempting to quit smoking receive pharmacotherapy, participants will also receive the transdermal nicotine patch for 8 weeks.
No Intervention: Standard of Care; At each clinic, routine assessment of smoking status occurs at least annually for patients receiving care, but prescription for pharmacotherapy for smoking cessation and referral for behavioral smoking cessation services are rare. Patients will receive the standard of care at the clinic they attend. SOC patients will also attend the first session that participants in the other sessions receive (pre-randomization), will come to the clinic for assessment only during the weeks lining up with sessions 6-10 for the other conditions, and receive the transdermal nicotine patch for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-Term Point Prevalence Smoking Abstinence	Biologically verified 7-day point prevalence abstinence (PPA). Using the timeline follow-back method (TLFB), participants will self-report the last time they smoked. TLFB results will be biologically verified with carbon monoxide analysis of breath samples (if stated abstinence is between 24 hours and 2 weeks), saliva cotinine (if stated abstinence is 2+ weeks and participant is currently using nicotine replacement therapy), or urine anabasine (if stated abstinence is 2+ weeks and participant is not currently using nicotine replacement therapy).	Time frame: 1-Month Follow-Up (end of treatment/approximately 1-month post quit date)
Long-Term Point Prevalence Smoking Abstinence	Biologically verified 7-day point prevalence abstinence (PPA). Using the timeline follow-back method (TLFB), participants will self-report the last time they smoked. TLFB results will be biologically verified with carbon monoxide analysis of breath samples (if stated abstinence is between 24 hours and 2 weeks), saliva cotinine (if stated abstinence is 2+ weeks and participant is currently using nicotine replacement therapy), or urine anabasine (if stated abstinence is 2+ weeks and participant is not currently using nicotine replacement therapy).	Time frame: 6-Month Follow-Up (approximately 6-months post quit date)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Baylor College of Medicine; University of Houston; University of Texas at Austin; Southern Methodist University; The Fenway Institute
• Investigators: Principal Investigator: Michael Zvolensky, PhD, University of Houston; Principal Investigator: Jasper Smits, PhD, University of Texas at Austin

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2019
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): February 28, 2024

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: HIV; Tobacco Use; Cognitive Behavioral Therapy; Physiological Effects of Drugs; Nicotine; Peripheral Nervous System Agents; Substance-Related Disorders; Anhedonia; Depressive Symptoms; Tobacco Use Disorder; Autonomic Agents; Neurotransmitter Agents; Anxiety Symptoms; Molecular Mechanisms of Pharmacological Action; Anxiety Sensitivity; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Anxious; Quitting; Distress Intolerance
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; RNA Virus Infections; Virus Diseases; Infections; Mood Disorders; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Depression; Depressive Disorder; HIV Infections; Anxiety Disorders; Tobacco Use Disorder; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: R01DA047933 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: One year following achievement of aims of the project (i.e., publication of the main outcome paper), de-identified data from this project will be provided to interested individuals. These data will be provided in digital format with clear labels for all variables. Data will be released directly by the investigators providing evidence of their institution's IRB approval for planned analyses of the data. The study team will be available to address queries.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No