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

NCT03904186

CompletedNA

Sponsor: Massachusetts General Hospital

Conditions: Human Immunodeficiency Virus, Smoking Cessation, Smoking, Cigarette, Smoking, Anxiety

Interventions: QUIT, Time-Matched Control (TM)

Countries: United States

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 79 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (3)
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Houston, Texas, United States