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Completed

NCT Number: NCT04043728

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Unified Protocol adapted for smoking cessation

Behavioral

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. All participants will be provided with the American Lung Association Freedom from Smoking guide to aid in their quit attempt.

Primary outcomes

  1. Number of Participants Who Achieved 24-hour Smoking Abstinence at End-of-treatment

    Time frame: 24 hours post-quit date

    The clinical endpoint will be achievement of 24-hour smoking abstinence at end-of-treatment, as verified by CO < 5 ppm.

Secondary outcomes

  1. Percent Change in Smoking Motives Questionnaire-Revised (SMQ-R) Average Score

    Time frame: Through active treatment phase (approximately 4 weeks)

    The secondary outcome is percent change in Smoking Motives Questionnaire-Revised (SMQ-R) average score. The SMQ-R measures the construct of smoking for affect regulation (i.e., smoking to improve mood or reduce distress). SMQ-R average score is computed as the average of 13 items, each assessed on a 0 to 100 scale, with higher scores indicating greater smoking for affect regulation.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 2, 2019
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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