Integrated Treatment for Smoking Cessation & Anxiety in People With HIV



Status:Completed
Conditions:Anxiety, Smoking Cessation, HIV / AIDS, Tobacco Consumers
Therapuetic Areas:Immunology / Infectious Diseases, Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:3/22/2019
Start Date:October 2011
End Date:May 2015

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During the 1-year formative phase of a study to develop an integrated treatment for quitting
smoking for anxiety-vulnerable HIV+ smokers. During this first phase of the study, start-up
activities will include piloting the integrated treatment on a small group of individuals (N
= up to 12), obtaining expert consultant and participant feedback, and development of the
final treatment manual and procedures. The goal during this phase will be to establish
feasibility of treatment delivery, participant acceptability, and potential for a treatment
effect before conducting a pilot randomized trial of the treatment. During the two-year pilot
RCT phase of the above study, we directly develop and test a novel psychosocial/behavioral
and pharmacological smoking cessation intervention for HIV+ smokers with interfering
psychological distress.

This study represents an important step in treating nicotine dependence in HIV-positive
individuals. This study addresses an important public health issue by assessing an
intervention that may lead to a more effective application for the treatment of at-risk HIV+
smokers. The 1-year formative phase of the study will develop an integrated treatment for
quitting smoking for anxiety-vulnerable HIV+ smokers. The proposed treatment will include
cognitive-behavioral talk therapy for quitting smoking, a nicotine patch, and
cognitive-behavioral talk therapy for anxiety. The pilot of the proposed treatment will be
conducted with a small group of individuals (N = up to 12). This phase will be used to
establish feasibility of treatment delivery, and participant acceptability before conducting
a pilot randomized trial of the treatment. Additionally, this phase will monitor smoking
cessation history through Point Prevalence Abstinence (PPA), as well as anxiety symptoms
through the Anxiety Sensitivity Index (ASI) at the baseline and follow-up assessments. This
study represents an important step in treating nicotine dependence in HIV-positive
individuals. This study addresses an important public health issue by assessing an
intervention that may lead to a more effective application for the treatment of at-risk HIV+
smokers. The pilot RCT phase of the study (years 2 and 3), will test the developed
cognitive-behavioral intervention in a pilot randomized-controlled trial format. The outcomes
for this trial will be to determine the acceptability and feasibility of the intervention and
the potential for an effect on increasing point prevalence abstinence and deceasing
psychological distress.

Inclusion Criteria:

- 18-65 years old

- Informed consent

- Daily smoker

- Motivated to quit smoking

Exclusion Criteria:

- Use of other tobacco products

- Untreated or unstable psychiatric disorders

- Current use of cognitive-behavioral therapy or medication for smoking cessation
treatment

- Insufficient command of English
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
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