Cigarette Smoking, Copd, Nicotine Dependence, Smoking Cessation, Tobacco Use
Conditions
Keywords
COPD, Smoking cessation, Nicotine dependence, Tobacco use, Cigarette smoking, Behavioral treatment
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).
Interventions
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.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved 24-hour Smoking Abstinence at End-of-treatment | 24 hours post-quit date | The clinical endpoint will be achievement of 24-hour smoking abstinence at end-of-treatment, as verified by CO \< 5 ppm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Smoking Motives Questionnaire-Revised (SMQ-R) Average Score | Through active treatment phase (approximately 4 weeks) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 6 |
| 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).
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. | 6 |
| 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.
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. | 6 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | Mindfulness | Interoceptive Exposure (Practice Quitting) | Behavioral Activation (Countering Emotional Behaviors) | Total |
|---|---|---|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 6.1 | 61.5 years STANDARD_DEVIATION 6.4 | 63.3 years STANDARD_DEVIATION 4 | 60.6 years STANDARD_DEVIATION 6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 6 Participants | 6 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 5 Participants | 6 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 4 Participants | 14 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
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.
Time frame: 24 hours post-quit date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness | Number of Participants Who Achieved 24-hour Smoking Abstinence at End-of-treatment | 1 Participants |
| Interoceptive Exposure (Practice Quitting) | Number of Participants Who Achieved 24-hour Smoking Abstinence at End-of-treatment | 1 Participants |
| Behavioral Activation (Countering Emotional Behaviors) | Number of Participants Who Achieved 24-hour Smoking Abstinence at End-of-treatment | 2 Participants |
Secondary
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.
Time frame: Through active treatment phase (approximately 4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness | Percent Change in Smoking Motives Questionnaire-Revised (SMQ-R) Average Score | -0.11 Percent score change | Standard Deviation 0.24 |
| Interoceptive Exposure (Practice Quitting) | Percent Change in Smoking Motives Questionnaire-Revised (SMQ-R) Average Score | -0.32 Percent score change | Standard Deviation 0.25 |
| Behavioral Activation (Countering Emotional Behaviors) | Percent Change in Smoking Motives Questionnaire-Revised (SMQ-R) Average Score | -0.11 Percent score change | Standard Deviation 0.2 |