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

Completed · Not applicable

Conditions studied: Human Immunodeficiency Virus, Smoking Cessation, Smoking, Cigarette, Smoking, Anxiety, Depression, Nicotine Dependence

In brief

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).

Key facts

Study ID

NCT03904186

Run by

Massachusetts General Hospital

People needed

131

Starts

2019-12-19

Expected to finish

2025-02-28

Last updated by the study team

2026-02-09

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-79 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Fenway Community Health — Boston, Massachusetts, United States
• Thomas Street Health Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.