Effectiveness of an Integrated Treatment to Address Smoking Cessation and Anxiety/ Depression in People Living With HIV
1 other identifier
interventional
131
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2019
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2019
CompletedFirst Posted
Study publicly available on registry
April 5, 2019
CompletedStudy Start
First participant enrolled
December 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2025
CompletedFebruary 9, 2026
February 1, 2026
5 years
April 3, 2019
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
Study Arms (3)
QUIT Treatment for Smoking Cessation and Distress Tolerance
EXPERIMENTALParticipants in this intervention arm will receive a Cognitive-Behavioral therapy-based intervention for smoking cessation in people living with HIV.
Time and Intensity-Match Control
ACTIVE COMPARATORParticipants in this control arm will receive an intervention matched in time and intensity with the experimental arm.
Standard of Care
NO INTERVENTIONAt 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- years old
- Daily Smoker
- Motivated to quit smoking
- HIV-positive
- Capability and willingness to give written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- The Fenway Institutecollaborator
- University of Texas at Austincollaborator
- University of Houstoncollaborator
- Baylor College of Medicinecollaborator
- Southern Methodist Universitycollaborator
Study Sites (3)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Fenway Community Health
Boston, Massachusetts, 02215, United States
Thomas Street Health Center
Houston, Texas, 77009, United States
Related Publications (1)
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.
PMID: 33933667DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jasper Smits, PhD
University of Texas at Austin
- PRINCIPAL INVESTIGATOR
Michael Zvolensky, PhD
University of Houston
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychology
Study Record Dates
First Submitted
April 3, 2019
First Posted
April 5, 2019
Study Start
December 19, 2019
Primary Completion
December 1, 2024
Study Completion
February 28, 2025
Last Updated
February 9, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
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.