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

Copd Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04646174
• Other study ID #: 18082201
• Status: Completed
• Phase: N/A
• Start date: December 14, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• 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.
• American 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.

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	Two-Week Smoking Abstinence	Number of days abstinent for 2 weeks post-quit, as verified by CO < 5 ppm	14 days post-quit date
Secondary	Smoking Status	Self-reported 7-day point prevalence abstinence, as verified by CO < 5 ppm	3 months post-quit