A Cognitive Behavioral Stress Intervention for Women Who Smoke

NCT03077945 | Completed

• 1 other identifier: 16-782M
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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.
2. 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.

Conditions

Smoking, Cigarette; Smoking Cessation; Stress; Stress, Emotional; Stress Reaction

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Change in cigarette craving

  Change in self-reported craving to smoke a cigarette as reported in the Questionnaire on Smoking Urges - Brief (QSU-B).

  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 heart rate variability

  Change in heart rate variability over the course of the study, as recorded on Biopac Acqknowledge software

  3 hours

• Performance on a stress task

  Performance on the color-word Stroop task

  10-15 minutes

Secondary Outcomes (1)

• Changes in smoking behavior at follow-up

  followup phone calls take place one week after the study visit

Study Arms (2)

Intervention Condition

EXPERIMENTAL

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

Control Condition

PLACEBO COMPARATOR

This group will complete control tasks, including viewing neutral videos.

Behavioral: control tasks

Interventions

heart rate variability biofeedback and cognitive reappraisal BEHAVIORAL

Intervention Condition

control tasks BEHAVIORAL

Control Condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Nepalese Psychological Association: collaborator
• New Jersey Psychological Association: collaborator

Study Sites (1)

Institute for Health, Health Care Policy and Aging Research

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Smoking Cessation; Stress, Psychological; Fractures, Stress; Recurrence; Self-Control; Emotional Regulation; Arrhythmia, Sinus

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Health Behavior; Behavioral Symptoms; Fractures, Bone; Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Social Behavior; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases

Study Officials

• Yasmine Omar, M.S.

  Rutgers, The State University of New Jersey

  STUDY DIRECTOR

• Edward Selby, Ph.D.

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychology PhD Candidate

Model Details: Participants will be randomized to the intervention or control condition, blocked by age and level of motivation to quit smoking.

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 13, 2017
• Study Start: December 1, 2016
• Primary Completion: May 30, 2017
• Study Completion: May 30, 2017
• Last Updated: March 14, 2018

Record last verified: 2018-03

Locations

US (1)