Cognitive Behavioral Therapy for Smoking Cessation in HIV/AIDS

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byMichael Zvolensky, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Research Team

Jasper Smits, PhD

Principal Investigator

University of Texas at Austin

Michael Zvolensky, PhD

Principal Investigator

University of Houston

Eligibility Criteria

This trial is for HIV-positive individuals aged 18-79 who smoke daily and are motivated to quit. They must understand English well enough to give informed consent. People using other tobacco products, undergoing current smoking cessation treatment, or with untreated/unstable psychiatric disorders can't participate.

Inclusion Criteria

I am between 18 and 79 years old.

HIV-positive

You are willing to stop smoking.

See 2 more

Exclusion Criteria

I do not have untreated or unstable mental health issues.

You use tobacco products regularly, except for cigarettes.

Insufficient command of the English language

See 2 more

Treatment Details

Interventions

QUIT (Behavioural Intervention)
Time-Matched Control (TM) (Behavioural Intervention)

Trial OverviewThe study tests a cognitive-behavioral-based intervention called QUIT against a Time-Matched Control (TM) to help smokers living with HIV quit by reducing anxiety and depression. It's a fully powered trial aiming to see if the intervention increases abstinence from smoking at 1-month and 6-month follow-ups.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: QUIT Treatment for Smoking Cessation and Distress ToleranceExperimental Treatment1 Intervention

Participants in this intervention arm will receive a Cognitive-Behavioral therapy-based intervention for smoking cessation in people living with HIV.

Group II: Time and Intensity-Match ControlActive Control1 Intervention

Participants in this control arm will receive an intervention matched in time and intensity with the experimental arm.

Group III: Standard of CareActive Control1 Intervention

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.