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Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start-II 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
American Lung Association self-management strategies 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, Self-guided 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 Type

Experimental

Experimental

Arm Label

Multi-component Behavioral Treatment

Self-guided Treatment

Arm Description

This treatment consists of nine weekly phone-based individual treatment sessions, 45-60 minutes each, delivered by a trained study therapist.

This treatment consists of self-help materials from the American Lung Association that address evidence-based smoking cessation and self-management strategies.

Outcomes

Primary Outcome Measures

Two-Week Smoking Abstinence
Number of days abstinent for 2 weeks post-quit, as verified by CO < 5 ppm

Secondary Outcome Measures

Smoking Status
Self-reported 7-day point prevalence abstinence, as verified by CO < 5 ppm

Full Information

First Posted
November 20, 2020
Last Updated
March 27, 2023
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04646174
Brief Title
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start-II Study
Official Title
Addressing Psychological Risk Factors Underlying Smoking Persistence: The Fresh Start-II Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (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 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).

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, Self-guided Treatment

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Multi-component Behavioral Treatment
Arm Type
Experimental
Arm Description
This treatment consists of nine weekly phone-based individual treatment sessions, 45-60 minutes each, delivered by a trained study therapist.
Arm Title
Self-guided Treatment
Arm Type
Experimental
Arm Description
This treatment consists of self-help materials from the American Lung Association that address evidence-based smoking cessation and self-management strategies.
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.
Intervention Type
Behavioral
Intervention Name(s)
American Lung Association self-management strategies for smoking cessation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Two-Week Smoking Abstinence
Description
Number of days abstinent for 2 weeks post-quit, as verified by CO < 5 ppm
Time Frame
14 days post-quit date
Secondary Outcome Measure Information:
Title
Smoking Status
Description
Self-reported 7-day point prevalence abstinence, as verified by CO < 5 ppm
Time Frame
3 months post-quit

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 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-II Study

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