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

NCT ID: NCT04646174

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-14
• Study Completion Date: 2022-12-31

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multi-component Behavioral Treatment

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

Group Type: EXPERIMENTAL

Unified Protocol adapted for smoking cessation

Intervention Type: 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.

American Lung Association self-management strategies for smoking cessation

Intervention Type: 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.

Self-guided Treatment

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

Group Type: EXPERIMENTAL

American Lung Association self-management strategies for smoking cessation

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amanda Mathew, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

18082201

Identifier Type: -

Identifier Source: org_study_id