Integrated Treatment for Smoking Cessation & Anxiety in People With HIV (Project Quit)
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ClinicalTrials.gov Identifier: NCT01393301 |
Recruitment Status
:
Completed
First Posted
: July 13, 2011
Last Update Posted
: April 26, 2017
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Condition or disease | Intervention/treatment | Phase |
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Nicotine Dependence Symptoms of Anxiety HIV | Behavioral: Integrated cognitive-behavioral therapy for smoking cessation and anxiety Behavioral: Control | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 72 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (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 |
Official Title: | Integrated Treatment for Smoking Cessation & Anxiety in People With HIV |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | May 2015 |
Actual Study Completion Date : | May 2015 |
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.
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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
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Control Arm
Enhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT).
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Behavioral: Control
Enhanced standard smoking cessation treatment and NRT.
Other Name: Enhanced Treatment as Usual (ETAU)
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- 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.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393301
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Conall O'Cleirigh, Ph.D. | Massachusetts General Hospital |
Responsible Party: | Conall O'Cleirigh, Ph.D., Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01393301 History of Changes |
Other Study ID Numbers: |
R34DA031038-01A1 ( U.S. NIH Grant/Contract ) 1R34DA031038-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | July 13, 2011 Key Record Dates |
Last Update Posted: | April 26, 2017 |
Last Verified: | April 2017 |
Keywords provided by Conall O'Cleirigh, Massachusetts General Hospital:
Nicotine dependence Smoking, cessation Quitting Anxiety symptoms Cognitive-behavioral therapy |
Additional relevant MeSH terms:
Anxiety Disorders Tobacco Use Disorder Mental Disorders Substance-Related Disorders Chemically-Induced Disorders Nicotine Ganglionic Stimulants Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |