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Completed

NCT Number: NCT01393301

Integrated Treatment for Smoking Cessation & Anxiety in People With HIV

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.

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Key information

Conditions

Nicotine Dependence Anxiety Disorders Behavior Chemically-Induced Disorders HIV Health Behavior Mental Disorders Smoking Cessation Substance-Related Disorders Symptoms of Anxiety Tobacco Use Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrated cognitive-behavioral therapy for smoking cessation and anxiety

Behavioral

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

Control

Behavioral

Enhanced standard smoking cessation treatment and NRT.

Other names: Enhanced Treatment as Usual (ETAU)

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

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

Registry information

Acronym: Project Quit

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 13, 2011
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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