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Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study

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Status

Completed

Conditions

Cigarette Smoking
Nicotine Dependence
Copd
Tobacco Use
Smoking Cessation

Treatments

Behavioral: Unified Protocol adapted for smoking cessation

Study type

Interventional

Funder types

Other

Identifiers

NCT04043728
ORA # 18082201

Details and patient eligibility

About

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.

Full 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).

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 3 patient groups

Mindfulness
Experimental group
Description:
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.
Treatment:
Behavioral: Unified Protocol adapted for smoking cessation
Interoceptive Exposure (Practice Quitting)
Experimental group
Description:
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).
Treatment:
Behavioral: Unified Protocol adapted for smoking cessation
Behavioral Activation (Countering Emotional Behaviors)
Experimental group
Description:
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.
Treatment:
Behavioral: Unified Protocol adapted for smoking cessation

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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