Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
24 februari 2021 uppdaterad av: Rush University Medical Center
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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Interventionell
Inskrivning (Faktisk)
18
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60612
- Rush University Medical Center
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
|
Experimentell: 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).
|
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.
|
|
Experimentell: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants Who Achieved 24-hour Smoking Abstinence at End-of-treatment
Tidsram: 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.
|
24 hours post-quit date
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percent Change in Smoking Motives Questionnaire-Revised (SMQ-R) Average Score
Tidsram: 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.
|
Through active treatment phase (approximately 4 weeks)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
9 september 2019
Primärt slutförande (Faktisk)
31 mars 2020
Avslutad studie (Faktisk)
31 mars 2020
Studieregistreringsdatum
Först inskickad
1 augusti 2019
Först inskickad som uppfyllde QC-kriterierna
1 augusti 2019
Första postat (Faktisk)
2 augusti 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 mars 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 februari 2021
Senast verifierad
1 februari 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ORA # 18082201
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
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Nej
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Nej
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