CopdNCT04646174
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start-II Study
A study testing Unified Protocol adapted for smoking cessation and American Lung Association self-management strategies 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 and American Lung Association self-management strategies for smoking cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Official title: Addressing Psychological Risk Factors Underlying Smoking Persistence: The Fresh Start-II 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 proposed research will develop and 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: Examine effects of psychological risk factor reduction on smoking outcome. We will conduct a pilot trial in which 62 participants are randomized to the multi-component behavioral treatment (9 weekly sessions) or self-guided treatment (mailing of printed self-help materials).The primary outcome is number of days abstinent for 2 weeks post-quit (range = 0-14 days).
- Conditions
- Copd, Smoking Cessation, Nicotine Dependence, Tobacco Use, Cigarette Smoking
- Being tested
- Unified Protocol adapted for smoking cessation, American Lung Association self-management strategies for smoking cessation
- Keywords
- Copd, Smoking Cessation, Nicotine Dependence, Tobacco Use, Cigarette Smoking, Behavioral Treatment, Self-guided 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.
American Lung Association self-management strategies for smoking cessationBehavioural
Treatment components are self-management strategies provided through printed self-help materials from the American Lung Association. The materials consist of the Freedom from Smoking guide, Relaxation Exercises for Better Breathing, and COPD; Exercise and Daily Activity guide that address evidence-based smoking cessation and self-management strategies to aid in a quit attempt.
| Study group | Role | What they receive |
|---|---|---|
| Multi-component Behavioral Treatment | Experimental | This treatment consists of nine weekly phone-based individual treatment sessions, 45-60 minutes each, delivered by a trained study therapist. Receives: Behavioral: Unified Protocol adapted for smoking cessation; Behavioral: American Lung Association self-management strategies for smoking cessation |
| Self-guided Treatment | Experimental | This treatment consists of self-help materials from the American Lung Association that address evidence-based smoking cessation and self-management strategies. Receives: Behavioral: American Lung Association self-management strategies for smoking cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-Week Smoking Abstinence
Number of days abstinent for 2 weeks post-quit, as verified by CO < 5 ppm
Measured: 14 days post-quit date
Secondary outcomes (1)
Smoking Status
Self-reported 7-day point prevalence abstinence, as verified by CO < 5 ppm
Measured: 3 months post-quit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start14 Dec 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda Mathew, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646174
- Sponsor's protocol ID
- 18082201
- Status last verified
- Mar 2023
- First submitted
- 20 Nov 2020
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Psychological Risk Factors Underlying Smoking Persistence: The Fresh Start-II Study
- ClinicalTrials.gov ID
- NCT04646174
- Acronym / sponsor ID
- 18082201
- Conditions
- Copd, Smoking Cessation, Nicotine Dependence, Tobacco Use, Cigarette Smoking
- Keywords
- Copd, Smoking Cessation, Nicotine Dependence, Tobacco Use, Cigarette Smoking, Behavioral Treatment, Self-guided Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 27 Nov 2020 (actual)
- Results
- Not posted in the source record
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 proposed research will develop and 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: Examine effects of psychological risk factor reduction on smoking outcome. We will conduct a pilot trial in which 62 participants are randomized to the multi-component behavioral treatment (9 weekly sessions) or self-guided treatment (mailing of printed self-help materials).The primary outcome is number of days abstinent for 2 weeks post-quit (range = 0-14 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-component Behavioral Treatment | Experimental | Behavioral: Unified Protocol adapted for smoking cessation, Behavioral: American Lung Association self-management strategies for smoking cessationThis treatment consists of nine weekly phone-based individual treatment sessions, 45-60 minutes each, delivered by a trained study therapist. |
| Self-guided Treatment | Experimental | Behavioral: American Lung Association self-management strategies for smoking cessationThis treatment consists of self-help materials from the American Lung Association that address evidence-based smoking cessation and self-management strategies. |
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. | Behavioural | Multi-component Behavioral Treatment |
| American Lung Association self-management strategies for smoking cessationTreatment components are self-management strategies provided through printed self-help materials from the American Lung Association. The materials consist of the Freedom from Smoking guide, Relaxation Exercises for Better Breathing, and COPD; Exercise and Daily Activity guide that address evidence-based smoking cessation and self-management strategies to aid in a quit attempt. | Behavioural | Multi-component Behavioral Treatment, Self-guided Treatment |
Primary outcome
Two-Week Smoking Abstinence
Time frame: 14 days post-quit date
Number of days abstinent for 2 weeks post-quit, as verified by CO < 5 ppm
1 secondary outcome
Smoking Status
Time frame: 3 months post-quit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Copd
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A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
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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 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 and American Lung Association self-management strategies 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 29 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Two-Week Smoking Abstinence (time frame: 14 days post-quit date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2023.