Integrated Treatment for Smoking Cessation & Anxiety in People With HIV Phase 1 (Project Quit)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This is the 1-year initial 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 = 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Nicotine Dependence Symptoms of Anxiety HIV |
Behavioral: Integrated cognitive-behavioral therapy for smoking cessation and anxiety |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Integrated Treatment for Smoking Cessation & Anxiety in People With HIV Phase 1 |
- Treatment Acceptability [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 12 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
-
Behavioral: Integrated cognitive-behavioral therapy for smoking cessation and anxiety
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 initial 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 done with a small group of individuals (N = 12). This phase will be used to establish feasibility of treatment delivery, participant acceptability, and potential for a treatment effect 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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18-65 years old
- Informed consent
- Daily smoker
- Motivated to quit smoking
- Anxiety symptom elevation
Exclusion Criteria:
- Use of other tobacco products
- Untreated or unstable psychiatric disorders
- Current use of cognitive-behavioral therapy or medication for smoking cessation treatment
- Cognitive-behavioral therapy for anxiety within the past year
- Insufficient command of English
Contacts and Locations| Contact: Conall O'Cleirigh, Ph.D. | 617-643-0385 | cocleirigh@partners.org |
| Contact: Jesse Kosiba, BA | 617-724-0637 |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Conall O'Cleirigh, Ph.D. 617-643-0385 cocleirigh@partners.org | |
| Contact: Jesse Kosiba, BA 617-724-0637 | |
| Principal Investigator: Conall O'Cleirigh, Ph.D. | |
More Information
No publications provided
| Responsible Party: | Conall O'Cleirigh, Ph.D., Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01393301 History of Changes |
| Other Study ID Numbers: | R34 DA031038-01A1, 1R34DA031038-01A1 |
| Study First Received: | July 11, 2011 |
| Last Updated: | February 24, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Massachusetts General Hospital:
|
Nicotine dependence Smoking, cessation Quitting Anxiety symptoms Cognitive-behavioral therapy |
Additional relevant MeSH terms:
|
Anxiety Disorders Tobacco Use Disorder Smoking |
Mental Disorders Substance-Related Disorders Habits |
ClinicalTrials.gov processed this record on May 19, 2013