N/A
N=18
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
Copd · Smoking Cessation · Nicotine Dependence · Tobacco Use · Cigarette Smoking
Bottom Line
View on ClinicalTrials.gov: NCT04043728 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Number of Participants Who Achieved 24-hour Smoking Abstinence at End-of-treatment — 1; 1; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Unified Protocol adapted for smoking cessation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieved 24-hour Smoking Abstinence at End-of-treatment |
1; 1; 2 | — |
| SECONDARY Percent Change in Smoking Motives Questionnaire-Revised (SMQ-R) Average Score |
-0.11; -0.32; -0.11 | — |
Summary
Chronic Obstructive Pulmonary Disease (COPD) is caused primarily by smoking and smoking cessation is the first-line treatment for slowing disease progression. Despite this, nearly 50% of COPD patients continue to smoke following diagnosis. Smokers with COPD report high rates of co-occurring conditions - nicotine dependence, depression, and anxiety - which serve as barriers to quitting. The current study will pilot test a behavioral intervention designed to target the common psychological factors underlying these co-occurring conditions and foster smoking cessation among COPD patients.
Eligibility Criteria
Inclusion Criteria
Eligible participants will be males and females who are:
- Diagnosed with COPD (as documented in electronic health record [EHR]),
- Daily cigarette smokers (5 or more cigarettes per day over past 30 days),
- Intend to quit smoking within the next 60 days,
- Report at least moderate level of smoking for affective regulation (SMQ-R coping subscale score 30 or greater),
- Have access to a smart phone, tablet, or computer, and
- Are able to communicate fluently in English
Exclusion Criteria
- Any concurrent medical or psychiatric condition which would preclude ability to provide informed consent or perform study procedures (e.g., moderate to severe dementia and/or severe, uncontrolled schizophrenia), as determined by the treating physician or study PI.
Data sourced from ClinicalTrials.gov (NCT04043728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.