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

Rush

Status: Completed

Conditions: Cigarette Smoking; Nicotine Dependence; Copd; Tobacco Use; Smoking Cessation

Treatments: Behavioral: American Lung Association self-management strategies for smoking cessation; Behavioral: Unified Protocol adapted for smoking cessation

Study type: Interventional

Funder types: Other

Identifiers

NCT04646174

18082201

Details and patient eligibility

About

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.

Full 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).

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Multi-component Behavioral Treatment

Experimental group

Description:

This treatment consists of nine weekly phone-based individual treatment sessions, 45-60 minutes each, delivered by a trained study therapist.

Treatment:

Behavioral: Unified Protocol adapted for smoking cessation

Behavioral: American Lung Association self-management strategies for smoking cessation

Self-guided Treatment

Experimental group

Description:

This treatment consists of self-help materials from the American Lung Association that address evidence-based smoking cessation and self-management strategies.

Treatment:

Behavioral: American Lung Association self-management strategies for smoking cessation