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

NCT04043728 | Completed Results

• 1 other identifier: ORA # 18082201
• Study Type: interventional
• Target: 18
• 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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Achieved 24-hour Smoking Abstinence at End-of-treatment

  The clinical endpoint will be achievement of 24-hour smoking abstinence at end-of-treatment, as verified by CO \< 5 ppm.

  24 hours post-quit date

Secondary Outcomes (1)

• Percent Change in Smoking Motives Questionnaire-Revised (SMQ-R) Average Score

  Through active treatment phase (approximately 4 weeks)

Study Arms (3)

Mindfulness

EXPERIMENTAL

This module introduces mindfulness training skills, with the goal of cultivating nonjudgmental, present-focused experience of emotions, thoughts, and physical sensations related to cigarette smoking. By progressing though a series of experiential exercises (e.g., awareness of the breath, anchoring in the present), this module seeks to reduce maladaptive attempts to control negative emotions and facilitate tolerance of the physical and emotional symptoms of nicotine withdrawal.

Behavioral: Unified Protocol adapted for smoking cessation

Interoceptive Exposure (Practice Quitting)

EXPERIMENTAL

This module introduces interoceptive exposure, a technique in which participants purposefully and systematically complete exercises to evoke physical sensations typically associated with anxiety and distress, in order to reduce fear and avoidance of these sensations. Interoceptive exercises will focus on a gradual exposure to nicotine withdrawal symptoms, through a series of 'practice quit attempts' (i.e., brief periods of smoking abstinence without intention to permanently quit).

Behavioral: Unified Protocol adapted for smoking cessation

Behavioral Activation (Countering Emotional Behaviors)

EXPERIMENTAL

This module introduces behavioral activation, which seeks to increase positive emotions by systematically introducing greater engagement with natural rewards. Treatment sessions focus on the identification of avoidance strategies, including cigarette smoking as a coping strategy for negative emotions. The goal of this treatment module is to replace smoking with adaptive coping strategies to facilitate contact with and enjoyment of reinforcing activities that are incompatible with smoking.

Behavioral: Unified Protocol adapted 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. All participants will be provided with the American Lung Association Freedom from Smoking guide to aid in their quit attempt.

Behavioral Activation (Countering Emotional Behaviors); Interoceptive Exposure (Practice Quitting); Mindfulness

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

Related Publications (1)

• Mathew AR, Avery EF, Cox C, Nwanah P, Kalhan R, Hitsman B, Powell LH. Development of a targeted behavioral treatment for smoking cessation among individuals with Chronic Obstructive Pulmonary Disease. J Behav Med. 2023 Dec;46(6):1010-1022. doi: 10.1007/s10865-023-00411-z. Epub 2023 May 6.

  PMID: 37148395 DERIVED

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

Results Point of Contact

• Title: Dr. Amanda Mathew
• Organization: Rush University Medical Center

amanda_mathew@rush.edu

13125631273

Study Officials

• Amanda R Mathew, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 2, 2019
• Study Start: September 9, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: March 17, 2021
• Results First Posted: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)