CopdNCT04043728
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
A study testing Unified Protocol adapted for smoking cessation in people with Copd and Smoking Cessation, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Copd, Smoking Cessation, Nicotine Dependence
- What is being tested?
- Unified Protocol adapted for smoking cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
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.
Read the 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
- Being tested
- Unified Protocol adapted for smoking cessation
- Keywords
- COPD, Smoking cessation, Nicotine dependence, Tobacco use, Cigarette smoking, Behavioral treatment
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Smoking Cessation, Tobacco Use Disorder, Tobacco Use, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Protocol adapted for smoking cessationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. Receives: Behavioral: Unified Protocol adapted for smoking cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours post-quit date
Secondary outcomes (1)
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.
Measured: Through active treatment phase (approximately 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start9 Sep 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda R Mathew, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043728
- Sponsor's protocol ID
- ORA # 18082201
- Status last verified
- Feb 2021
- First submitted
- 1 Aug 2019
- Last updated
- 17 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37148395
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
- ClinicalTrials.gov ID
- NCT04043728
- Acronym / sponsor ID
- ORA # 18082201
- Conditions
- Copd, Smoking Cessation, Nicotine Dependence, Tobacco Use, Cigarette Smoking
- Keywords
- COPD, Smoking cessation, Nicotine dependence, Tobacco use, Cigarette smoking, Behavioral treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Posted 25 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Unified Protocol adapted for smoking cessationThis 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. |
| Interoceptive Exposure (Practice Quitting) | Experimental | Behavioral: Unified Protocol adapted for smoking cessationThis 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 Activation (Countering Emotional Behaviors) | Experimental | Behavioral: Unified Protocol adapted for smoking cessationThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unified Protocol adapted for smoking cessationTreatment 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. | Behavioural | Behavioral Activation (Countering Emotional Behaviors), Interoceptive Exposure (Practice Quitting), Mindfulness |
Primary outcome
Number of Participants Who Achieved 24-hour Smoking Abstinence at End-of-treatment
Time frame: 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.
1 secondary outcome
Percent Change in Smoking Motives Questionnaire-Revised (SMQ-R) Average Score
Time frame: Through active treatment phase (approximately 4 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37148395Mathew 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda R Mathew, PhD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol adapted for smoking cessation in people with Copd and Smoking Cessation, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Achieved 24-hour Smoking Abstinence at End-of-treatment (time frame: 24 hours post-quit date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04043728, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.