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

Copd Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04043728
• Other study ID #: ORA # 18082201
• Status: Completed
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: February 2021
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cigarette Smoking
• Copd
• Nicotine Dependence
• Smoking Cessation
• Tobacco Use
• Tobacco Use Disorder

Intervention

Behavioral:
• Unified Protocol adapted for smoking cessation
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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Achieved 24-hour Smoking Abstinence at End-of-treatment	The clinical endpoint will be achievement of 24-hour smoking abstinence at end-of-treatment, as verified by CO < 5 ppm.	24 hours post-quit date
Secondary	Percent Change in Smoking Motives Questionnaire-Revised (SMQ-R) Average Score	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.	Through active treatment phase (approximately 4 weeks)