Integrated Treatment for Smoking Cessation & Anxiety in People With HIV
Project Quit
2 other identifiers
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2011
CompletedFirst Posted
Study publicly available on registry
July 13, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
March 20, 2019
CompletedMay 3, 2023
April 1, 2023
3.6 years
July 11, 2011
January 7, 2019
April 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Treatment Acceptability
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)
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)
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 Outcomes (1)
Treatment Related Changes in Psychological Distress.
6 months
Study Arms (2)
Behavioral Intervention Arm
EXPERIMENTALStandard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress.
Control Arm
OTHEREnhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT).
Interventions
Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress.
Enhanced standard smoking cessation treatment and NRT.
Eligibility Criteria
You may qualify if:
- years old
- Informed consent
- Daily smoker
- Motivated to quit smoking
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Southern Methodist Universitycollaborator
- University of Houstoncollaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (2)
Mdege ND, Shah S, Dogar O, Pool ER, Weatherburn P, Siddiqi K, Zyambo C, Livingstone-Banks J. Interventions for tobacco use cessation in people living with HIV. Cochrane Database Syst Rev. 2024 Aug 5;8(8):CD011120. doi: 10.1002/14651858.CD011120.pub3.
PMID: 39101506DERIVEDO'Cleirigh C, Zvolensky MJ, Smits JAJ, Labbe AK, Coleman JN, Wilner JG, Stanton AM, Gonzalez A, Garey L, Regenauer KS, Rosenfield D. Integrated Treatment for Smoking Cessation, Anxiety, and Depressed Mood in People Living With HIV: A Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2018 Oct 1;79(2):261-268. doi: 10.1097/QAI.0000000000001787.
PMID: 30212438DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Conall O'Cleirigh, PI
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Conall O'Cleirigh, Ph.D.
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- For formative stage of the study, no masking was used as that phase was an open pilot. Outcomes assessor masked during the pilot RCT.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.D.
Study Record Dates
First Submitted
July 11, 2011
First Posted
July 13, 2011
Study Start
October 1, 2011
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
May 3, 2023
Results First Posted
March 20, 2019
Record last verified: 2023-04