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

April 7, 2023 updated by: Conall O'Cleirigh, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • QUESTT
Other: 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 Names:
  • Enhanced Treatment as Usual (ETAU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Acceptability
Time Frame: 6 months

Acceptability is defined as intervention participant study completion. Study completion was defined by participants attending at least 7/10 treatment sessions.

Qualitative interviews were also conducted with participants at the end of the study.
6 months
Long-term Point Prevalence Abstinence (PPA; Pilot RCT Phase)
Time Frame: 6 months
Smoking outcomes are assessed at 6-month 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.
6 months
Short-term Point Prevalence Abstinence (PPA; Pilot RCT Phase)
Time Frame: 10 weeks
Smoking outcomes are assessed at end of treatment by comparing the reported 7 day abstinence (assessed through self-report and independent verification) across the randomized conditions controlling for pre-randomization levels.
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Related Changes in Psychological Distress.
Time Frame: 6 months
Treatment related changes in psychological distress was measured by combining the SIGH-A, MADRS, STAI-S, and CES-D into one scale score between baseline and the 6-month follow-up. In accordance with published recommendations, each psychological measure was z-scored to put all outcomes on the same scale. A z-score below 0 indicates a level of psychological distress below the mean (lower psychological distress), while a z-score above 0 indicates a level of psychological distress above the mean (higher psychological distress).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Institute on Drug Abuse (NIDA)
University of Houston
Southern Methodist University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

July 11, 2011

First Submitted That Met QC Criteria

July 12, 2011

First Posted (Estimate)

July 13, 2011

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 7, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34DA031038-01A1 (U.S. NIH Grant/Contract)
  • 1R34DA031038-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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