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

NCT04646174 | Completed

• 1 other identifier: 18082201
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Copd; Smoking Cessation; Nicotine Dependence; Tobacco Use; Cigarette Smoking; Behavioral Treatment; Self-guided Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Smoking Status

  3 months post-quit

Study Arms (2)

Multi-component Behavioral Treatment

EXPERIMENTAL

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

Self-guided Treatment

EXPERIMENTAL

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

Interventions

Unified Protocol adapted for smoking cessation BEHAVIORAL

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.

Multi-component Behavioral Treatment

American Lung Association self-management strategies for smoking cessation BEHAVIORAL

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.

Multi-component Behavioral Treatment; Self-guided Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Smoking Cessation; Tobacco Use Disorder; Tobacco Use; Cigarette Smoking

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Tobacco Smoking; Smoking

Study Officials

• Amanda Mathew, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 27, 2020
• Study Start: December 14, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)