NCT03077945

A Cognitive Behavioral Stress Intervention for Women Who Smoke

Completed NA Last updated 14 March 2018

What this trial tests

NA trial testing heart rate variability biofeedback and cognitive reappraisal in Smoking, Cigarette in 70 participants. Completed in 30 May 2017.

Timeline

1 December 2016

Primary endpoint
30 May 2017

30 May 2017

Quick facts

Lead sponsor	Rutgers, The State University of New Jersey
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	70
Start date	1 December 2016
Primary completion	30 May 2017
Estimated completion	30 May 2017
Sites	1 location across United States

Drugs / interventions tested

• heart rate variability biofeedback and cognitive reappraisal
• control tasks

Conditions studied

• Smoking, Cigarette — all drugs for Smoking, Cigarette →
• Smoking Cessation — all drugs for Smoking Cessation →
• Stress — all drugs for Stress →
• Stress, Emotional — all drugs for Stress, Emotional →

Sponsor

Rutgers, The State University of New Jersey

Who can join

Adults 18 to 65, female only, with Smoking, Cigarette or Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.