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Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start-II Study

Addressing Psychological Risk Factors Underlying Smoking Persistence: The Fresh Start-II Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04646174
Enrollment
66
Registered
2020-11-27
Start date
2020-12-14
Completion date
2022-12-31
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cigarette Smoking, Copd, Nicotine Dependence, Smoking Cessation, Tobacco Use

Keywords

Copd, Smoking Cessation, Nicotine Dependence, Tobacco Use, Cigarette Smoking, Behavioral Treatment, Self-guided 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 proposed research will develop and 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: Examine effects of psychological risk factor reduction on smoking outcome. We will conduct a pilot trial in which 62 participants are randomized to the multi-component behavioral treatment (9 weekly sessions) or self-guided treatment (mailing of printed self-help materials).The primary outcome is number of days abstinent for 2 weeks post-quit (range = 0-14 days).

Interventions

Treatment components are cognitive-behavioral strategies adapted from the Unified Protocol (UP) for the Transdiagnostic Treatment of Emotional Disorders. Behavioral counseling strategies for smoking cessation, drawn from current US Public Health Service guidelines, are incorporated in each treatment module.

BEHAVIORALAmerican Lung Association self-management strategies for smoking cessation

Treatment components are self-management strategies provided through printed self-help materials from the American Lung Association. The materials consist of the Freedom from Smoking guide, Relaxation Exercises for Better Breathing, and COPD; Exercise and Daily Activity guide that address evidence-based smoking cessation and self-management strategies to aid in a quit attempt.

Sponsors

Rush University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Two-Week Smoking Abstinence14 days post-quit dateNumber of days abstinent for 2 weeks post-quit, as verified by CO \< 5 ppm

Secondary

MeasureTime frameDescription
Smoking Status3 months post-quitSelf-reported 7-day point prevalence abstinence, as verified by CO \< 5 ppm

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026