Clinical trial NCT04043728: Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
Official title: Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Copd
Smoking Cessation
Nicotine Dependence
Tobacco Use
Cigarette Smoking
Keywords: COPD
Smoking cessation
Nicotine dependence
Tobacco use
Cigarette smoking
Behavioral treatment
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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. The specific aim is to:

Aim: Develop a multi-component behavioral treatment to address psychological risk factors among COPD patients. We will conduct a component analysis using single case design experiments with 15 participants to a) examine the contribution of each treatment component to the behavioral target of smoking for affect regulation, and b) establish proof-of-concept on the clinical endpoint of initial cessation (\>24 hours abstinence).

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.

Primary outcomes:
measure: Number of Participants Who Achieved 24-hour Smoking Abstinence at End-of-treatment
timeFrame: 24 hours post-quit date
Secondary outcomes:
measure: Percent Change in Smoking Motives Questionnaire-Revised (SMQ-R) Average Score
timeFrame: Through active treatment phase (approximately 4 weeks)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Amanda R Mathew, PhD
role: PRINCIPAL_INVESTIGATOR
References: