search
Back to results

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

Primary Purpose

Copd, Smoking Cessation, Nicotine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unified Protocol adapted for smoking cessation
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Copd focused on measuring COPD, Smoking cessation, Nicotine dependence, Tobacco use, Cigarette smoking, Behavioral treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Mindfulness

Interoceptive Exposure (Practice Quitting)

Behavioral Activation (Countering Emotional Behaviors)

Arm Description

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.

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percent Change in Smoking Motives Questionnaire-Revised (SMQ-R) Average Score
The secondary outcome is percent change in Smoking Motives Questionnaire-Revised (SMQ-R) average score. The SMQ-R measures the construct of smoking for affect regulation (i.e., smoking to improve mood or reduce distress). SMQ-R average score is computed as the average of 13 items, each assessed on a 0 to 100 scale, with higher scores indicating greater smoking for affect regulation.

Full Information

First Posted
August 1, 2019
Last Updated
February 24, 2021
Sponsor
Rush University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04043728
Brief Title
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
Official Title
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Copd, Smoking Cessation, Nicotine Dependence, Tobacco Use, Cigarette Smoking
Keywords
COPD, Smoking cessation, Nicotine dependence, Tobacco use, Cigarette smoking, Behavioral treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness
Arm Type
Experimental
Arm Description
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.
Arm Title
Interoceptive Exposure (Practice Quitting)
Arm Type
Experimental
Arm Description
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).
Arm Title
Behavioral Activation (Countering Emotional Behaviors)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Unified Protocol adapted for smoking cessation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Who Achieved 24-hour Smoking Abstinence at End-of-treatment
Description
The clinical endpoint will be achievement of 24-hour smoking abstinence at end-of-treatment, as verified by CO < 5 ppm.
Time Frame
24 hours post-quit date
Secondary Outcome Measure Information:
Title
Percent Change in Smoking Motives Questionnaire-Revised (SMQ-R) Average Score
Description
The secondary outcome is percent change in Smoking Motives Questionnaire-Revised (SMQ-R) average score. The SMQ-R measures the construct of smoking for affect regulation (i.e., smoking to improve mood or reduce distress). SMQ-R average score is computed as the average of 13 items, each assessed on a 0 to 100 scale, with higher scores indicating greater smoking for affect regulation.
Time Frame
Through active treatment phase (approximately 4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda R Mathew, PhD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs