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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03904186
Collaborator
The Fenway Institute (Other), University of Texas at Austin (Other), University of Houston (Other), Baylor College of Medicine (Other), Southern Methodist University (Other)
360
3
3
38.3
120
3.1

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: QUIT
  • Behavioral: Time-Matched Control (TM)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Effectiveness of an Integrated Treatment to Address Smoking Cessation and Anxiety/ Depression in People Living With HIV
Actual Study Start Date :
Dec 19, 2019
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Short-Term Point Prevalence Smoking Abstinence [Time frame: 1-Month Follow-Up (end of treatment/approximately 1-month post quit date)]

    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).

  2. Long-Term Point Prevalence Smoking Abstinence [Time frame: 6-Month Follow-Up (approximately 6-months post quit date)]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114
2 Fenway Community Health Boston Massachusetts United States 02215
3 Thomas Street Health Center Houston Texas United States 77009

Sponsors and Collaborators

  • Massachusetts General Hospital
  • The Fenway Institute
  • University of Texas at Austin
  • University of Houston
  • Baylor College of Medicine
  • Southern Methodist University

Investigators

  • Principal Investigator: Jasper Smits, PhD, University of Texas at Austin
  • Principal Investigator: Michael Zvolensky, PhD, University of Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Conall O'Cleirigh, Associate Professor of Psychology, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT03904186
Other Study ID Numbers:
  • R01DA047933
First Posted:
Apr 5, 2019
Last Update Posted:
Feb 3, 2021
Last Verified:
Feb 1, 2021

Study Results

No Results Posted as of Feb 3, 2021