Trial Outcomes & Findings for Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study (NCT NCT04043728)
NCT ID: NCT04043728
Last Updated: 2021-03-17
Results Overview
The clinical endpoint will be achievement of 24-hour smoking abstinence at end-of-treatment, as verified by CO \< 5 ppm.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
24 hours post-quit date
Results posted on
2021-03-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
5
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
Baseline Characteristics
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
Baseline characteristics by cohort
| Measure |
Mindfulness
n=6 Participants
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.
|
Interoceptive Exposure (Practice Quitting)
n=6 Participants
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.
|
Behavioral Activation (Countering Emotional Behaviors)
n=6 Participants
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.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
63.3 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 6.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 hours post-quit dateThe clinical endpoint will be achievement of 24-hour smoking abstinence at end-of-treatment, as verified by CO \< 5 ppm.
Outcome measures
| Measure |
Mindfulness
n=6 Participants
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.
|
Interoceptive Exposure (Practice Quitting)
n=6 Participants
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.
|
Behavioral Activation (Countering Emotional Behaviors)
n=6 Participants
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.
|
|---|---|---|---|
|
Number of Participants Who Achieved 24-hour Smoking Abstinence at End-of-treatment
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mindfulness
n=6 Participants
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.
|
Interoceptive Exposure (Practice Quitting)
n=6 Participants
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.
|
Behavioral Activation (Countering Emotional Behaviors)
n=6 Participants
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.
|
|---|---|---|---|
|
Percent Change in Smoking Motives Questionnaire-Revised (SMQ-R) Average Score
|
-0.11 Percent score change
Standard Deviation 0.24
|
-0.32 Percent score change
Standard Deviation 0.25
|
-0.11 Percent score change
Standard Deviation 0.20
|
Adverse Events
Mindfulness
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Interoceptive Exposure (Practice Quitting)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Behavioral Activation (Countering Emotional Behaviors)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place