Integrated Treatment for Smoking Cessation & Anxiety in People With HIV (Project Quit)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Nicotine Dependence; Symptoms of Anxiety; HIV	Behavioral: Integrated cognitive-behavioral therapy for smoking cessation and anxiety; Behavioral: Control	Not Applicable

Detailed Description:

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.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	72 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Masking Description:	For formative stage of the study, no masking was used as that phase was an open pilot. Outcomes assessor masked during the pilot RCT.
Primary Purpose:	Treatment
Official Title:	Integrated Treatment for Smoking Cessation & Anxiety in People With HIV
Study Start Date :	October 2011
Actual Primary Completion Date :	May 2015
Actual Study Completion Date :	May 2015

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Behavioral Intervention Arm; Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress.	Behavioral: Integrated cognitive-behavioral therapy for smoking cessation and anxiety; Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress.; Other Name: QUESTT
Control Arm; Enhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT).	Behavioral: Control; Enhanced standard smoking cessation treatment and NRT.; Other Name: Enhanced Treatment as Usual (ETAU)

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Treatment Acceptability (Formative Phase of R34) [ Time Frame: 6 months ]
   The investigators will use the Treatment CEQ, a 6-item measure, to assess treatment credibility and expectancy for participants between their baseline assessment and 6-month follow-up assessment. The investigators will administer the scale after the first treatment session. Acceptability will also be evaluated on the basis of participant retention, and participant self report. Participants' self-report of their reactions to the intervention and study participation will be assessed through a qualitative exit interview.
2. Short and long-term point prevalence abstinence (PPA; pilot RCT phase) [ Time Frame: 6 months ]
   Smoking outcomes are assessed post treatment and at follow up by comparing the reported 7 day abstinence (assessed through self-report and independent verification) across the randomized conditions controlling for pre-randomization levels.
3. Treatment related changes in psychological distress (pilot RCT phase) [ Time Frame: 6 months ]
   These changes are assessed through anxiety, depression, and/or distress tolerance checklists assessed post-treatment and at follow-up by comparing the total scale scores across the randomized conditions controlling for pre-randomization levels.

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Southern Methodist University

University of Houston

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:	Conall O'Cleirigh, Ph.D.	Massachusetts General Hospital

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Conall O'Cleirigh, Ph.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01393301 History of Changes
Other Study ID Numbers:	R34DA031038-01A1 ( U.S. NIH Grant/Contract ); 1R34DA031038-01A1 ( U.S. NIH Grant/Contract )
First Posted:	July 13, 2011
Last Update Posted:	April 26, 2017
Last Verified:	April 2017

Keywords provided by Conall O'Cleirigh, Massachusetts General Hospital:

Nicotine dependence; Smoking, cessation; Quitting; Anxiety symptoms; Cognitive-behavioral therapy

Additional relevant MeSH terms:

Anxiety Disorders; Tobacco Use Disorder; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Nicotine; Ganglionic Stimulants; Autonomic Agents	Peripheral Nervous System Agents; Physiological Effects of Drugs; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action