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

Rush University Medical Center66 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

Unified Protocol adapted for smoking cessationBEHAVIORAL

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 cessationBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Two-Week Smoking Abstinence

Number of days abstinent for 2 weeks post-quit, as verified by CO \< 5 ppm

Time frame: 14 days post-quit date

Secondary Outcomes

Smoking Status

Self-reported 7-day point prevalence abstinence, as verified by CO \< 5 ppm

Time frame: 3 months post-quit