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

Study Overview
=================
Brief 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.

Detailed 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).

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

Conditions
-----------------
Copd, Smoking Cessation, Nicotine Dependence, Tobacco Use, Cigarette Smoking

Intervention / Treatment
-----------------
* Behavioral: Unified Protocol adapted for smoking cessation
* Behavioral: American Lung Association self-management strategies for smoking cessation


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-component Behavioral Treatment<br>This treatment consists of nine weekly phone-based individual treatment sessions, 45-60 minutes each, delivered by a trained study therapist. | Behavioral: Unified Protocol adapted for smoking cessation<br>* 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.<br>Behavioral: American Lung Association self-management strategies for smoking cessation<br>* 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.<br>|
| Experimental: Self-guided Treatment<br>This treatment consists of self-help materials from the American Lung Association that address evidence-based smoking cessation and self-management strategies. | Behavioral: American Lung Association self-management strategies for smoking cessation<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Status | Self-reported 7-day point prevalence abstinence, as verified by CO < 5 ppm | 3 months post-quit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Copd, Smoking Cessation, Nicotine Dependence, Tobacco Use, Cigarette Smoking, Behavioral Treatment, Self-guided Treatment