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

NCT ID: NCT04043728

Last Updated: 2021-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-09
• Study Completion Date: 2020-03-31

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 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. The specific aim is to:

Aim: Develop a multi-component behavioral treatment to address psychological risk factors among COPD patients. We will conduct a component analysis using single case design experiments with 15 participants to a) examine the contribution of each treatment component to the behavioral target of smoking for affect regulation, and b) establish proof-of-concept on the clinical endpoint of initial cessation (>24 hours abstinence).

Conditions

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

Study Design

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

Study Groups

Mindfulness

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.

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

Interoceptive Exposure (Practice Quitting)

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).

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. 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)

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.

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. All participants will be provided with the American Lung Association Freedom from Smoking guide to aid in their 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. All participants will be provided with the American Lung Association Freedom from Smoking guide to aid in their 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 R Mathew, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37148395 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ORA # 18082201

Identifier Type: -

Identifier Source: org_study_id