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A Cognitive Behavioral Stress Intervention for Women Who Smoke

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ClinicalTrials.gov Identifier: NCT03077945
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : March 14, 2018
Sponsor:
Collaborators:
Nepalese Psychological Association
New Jersey Psychological Association
Information provided by (Responsible Party):
Yasmine Omar, Rutgers, The State University of New Jersey

Brief Summary:
  1. PURPOSE OF THE STUDY 1.1 Justification The purpose of the project is to examine the effect of breathing biofeedback and thoughts about stress on performance under stress and cigarette cravings. Smoking rates in the United States have been steadily going down over the past 50 years, and now 16.8% of adults smoke (Centers for Disease Control and Prevention, 2015). Most smokers try to quit, but end up going back to smoking (Garcia-Rodriguez et al., 2013; Piasecki, 2006; Rafful et al., 2013). The reasons people go back to smoking may have something to do with stress in their lives, particularly for women who smoke. This study wants to see if we can reduce temporary stress and lower craving to smoke after stress.

    1.2 Description of the Research Project Approximately 60 adult women will participate in the study. Participants must be between 18 and 65 years old, able to read English fluently, and must agree to engage in the research procedures (stress protocol, physiological assessment, breathing training, questionnaires) to participate. People who are taking medications that interfere with physiological assessment are excluded from participating including people with: self-identified substance use problems, self-identified psychosis, morbid obesity (BMI>40), and people who take anti-cholinergic medication, beta blockers, Ritalin, benzodiazepines, tricyclic antidepressants or bupropion, varenicline, antipsychotic medication, or nicotine replacement therapy. People who have a cardiac rhythm abnormality or major neurological problem are also excluded from the study. Also, participants may not participate if they are pregnant or color-blind. Participation is strictly voluntary.

  2. PROGRESSION OF THIS STUDY 2.1 Procedures The study visit procedures will take place at the Emotion and Psychopathology Laboratory at Rutgers University, located at the Rutgers Institute for Health, Healthcare Policy, and Aging Research. Participants will first complete some questionnaires and provide some basic information about themselves (demographic information, responses to emotion and stress, and smoking history). Next, participants will engage in a baseline psychophysiological assessment where investigators will examine heart rate, breathing, and blood pressure. Next, investigators will either ask participants to sit quietly for 30 minutes while completing a computer task and watching short videos, or practice a specific deep breathing exercise for 30 minutes. Then participants will do three tasks on a computer. The tasks will ask participants to trace different shapes, answer math problems while receiving feedback about how they're doing, and identify colors and words on a screen. Finally, participants will be asked to sit quietly for 15 minutes before investigators remove the psychophysiological recording equipment. One week after the study visit, investigators will contact participants via phone to ask them some questions about the study visit.

2.2 Duration of the study This study visit will last approximately 3 hours. Length of the visit may vary because each individual may complete procedures at a different pace. The phone call after the study visit will last approximately 10-15 minutes.


Condition or disease Intervention/treatment Phase
Smoking, Cigarette Smoking Cessation Stress Stress, Emotional Stress Reaction Behavioral: heart rate variability biofeedback and cognitive reappraisal Behavioral: control tasks Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to the intervention or control condition, blocked by age and level of motivation to quit smoking.
Masking: Single (Participant)
Primary Purpose: Basic Science
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : May 30, 2017

Arm Intervention/treatment
Experimental: Intervention Condition
This group will receive the heart rate variability biofeedback intervention in addition to the cognitive reappraisal of stress intervention
Behavioral: heart rate variability biofeedback and cognitive reappraisal
Placebo Comparator: Control Condition
This group will complete control tasks, including viewing neutral videos.
Behavioral: control tasks



Primary Outcome Measures :
  1. Change in cigarette craving [ Time Frame: Total time frame of measurement is 3 hours. The QSU-B will be completed at T=0, T=25, T=75, T=90 ]
    Change in self-reported craving to smoke a cigarette as reported in the Questionnaire on Smoking Urges - Brief (QSU-B).

  2. Change in heart rate variability [ Time Frame: 3 hours ]
    Change in heart rate variability over the course of the study, as recorded on Biopac Acqknowledge software

  3. Performance on a stress task [ Time Frame: 10-15 minutes ]
    Performance on the color-word Stroop task


Secondary Outcome Measures :
  1. Changes in smoking behavior at follow-up [ Time Frame: followup phone calls take place one week after the study visit ]
    changes in cigarettes smoked or methods of coping with stress or craving will be assessed one week after the study visit is completed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • To be included in the study, participants must report smoking at least 10 cigarettes per day, and agree to complete study procedures, which requires a willingness to practice quitting smoking.
  • They must also provide a breath carbon monoxide sample of at least 15ppm to verify their smoking status.

Exclusion Criteria:

  • Exclusionary criteria include being pregnant or trying to become pregnant
  • Color-blindness
  • Current psychosis, current substance dependence, current body mass index (BMI) of over 40
  • Current diagnosis of a cardiac rhythm abnormality (mitrovalve prolapse, frequent premature ventricular contractions
  • Atrial fibrillation, bundle branch block) or a major neurological problem, history of a myocardial infarction, or past-week use of illicit drugs
  • Nicotine replacement therapy, bupropion, varenicline, anti-cholinergic medications, beta blockers, Ritalin
  • Benzodiazepines
  • Tricyclic antidepressants
  • Antipsychotic medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077945


Locations
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United States, New Jersey
Institute for Health, Health Care Policy and Aging Research
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Nepalese Psychological Association
New Jersey Psychological Association
Investigators
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Study Director: Yasmine Omar, M.S. Rutgers, The State University of New Jersey
Principal Investigator: Edward Selby, Ph.D. Rutgers, The State University of New Jersey

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Responsible Party: Yasmine Omar, Clinical Psychology PhD Candidate, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03077945     History of Changes
Other Study ID Numbers: 16-782M
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yasmine Omar, Rutgers, The State University of New Jersey:
biofeedback
heart rate variability
HRV
psychophysiology
reappraisal
cognitive reappraisal
arousal reappraisal
woman
women
female
smoker
relapse
cigarette
craving
self regulation
emotion regulation
stress response
cognitive behavioral intervention
respiratory sinus arrhythmia
smoking cessation intervention
Additional relevant MeSH terms:
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Fractures, Stress
Stress, Psychological
Fractures, Bone
Wounds and Injuries
Behavioral Symptoms