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

This study has been completed.
Sponsor:
Collaborators:
Southern Methodist University
University of Houston
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Conall O'Cleirigh, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01393301
First received: July 11, 2011
Last updated: April 25, 2017
Last verified: April 2017
July 11, 2011
April 25, 2017
October 2011
May 2015   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
  • 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.
Treatment Acceptability [ 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, which will be considered favorable acceptability based on retention of 80% or greater of participants. Participants' self-report of their reactions to the intervention and study participation will be assessed through a qualitative exit interview.
Complete list of historical versions of study NCT01393301 on ClinicalTrials.gov Archive Site
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Integrated Treatment for Smoking Cessation & Anxiety in People With HIV
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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
  • Nicotine Dependence
  • Symptoms of Anxiety
  • HIV
  • 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
  • Behavioral: Control
    Enhanced standard smoking cessation treatment and NRT.
    Other Name: Enhanced Treatment as Usual (ETAU)
  • 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.
    Intervention: Behavioral: Integrated cognitive-behavioral therapy for smoking cessation and anxiety
  • Control Arm
    Enhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT).
    Intervention: Behavioral: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
May 2015
May 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01393301
R34DA031038-01A1
1R34DA031038-01A1 ( US NIH Grant/Contract Award Number )
Yes
Not Provided
Not Provided
Not Provided
Conall O'Cleirigh, Massachusetts General Hospital
Massachusetts General Hospital
  • Southern Methodist University
  • University of Houston
  • National Institute on Drug Abuse (NIDA)
Principal Investigator: Conall O'Cleirigh, Ph.D. Massachusetts General Hospital
Massachusetts General Hospital
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP