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NCT04646174 | COMPLETED | Copd

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

Rush University Medical Center

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.

Condition or disease

Copd

Smoking Cessation

Nicotine Dependence

Tobacco Use

Cigarette Smoking

Intervention/treatment

Unified Protocol adapted for smoking cessation

American Lung Association self-management strategies for smoking cessation

Phase

NA

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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 66 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Addressing Psychological Risk Factors Underlying Smoking Persistence: The Fresh Start-II Study
Actual Study Start Date : 2020-12-14
Estimated Primary Completion Date : 2022-12-31
Estimated Study Completion Date : 2022-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start-II Study

Location Details

NCT04646174

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Locations

Not yet recruiting

United States, Illinois

Rush University Medical Center

Chicago, Illinois, United States, 60612