NCT05224050

Heart Rate Variability Biofeedback for Smoking Cessation Treatment

Open Trial of Heart Rate Variability Biofeedback for Smoking Cessation Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to conduct an open trial examining the feasibility and acceptability of an adapted heart rate variability biofeedback and smoking cessation treatment that was using a primarily virtual remote intervention.

Detailed description

The present investigation is an open trial investigating the feasibility and acceptability of heart rate variability biofeedback smoking cessation treatment (HRVB-SCT) for individuals who smoke cigarettes. Significant findings will also support the expansion of HRVB as a transdiagnostic treatment adjunct that alters cardiac vagal functioning to promote emotional and behavioral regulation, changing the status quo of cognitive-behavioral intervention approaches and decreasing the health and economic burden of smokers who suffer from emotional distress. The goals are to: (a) assess the feasibility and acceptability of the HRVB-SCT intervention (b) assess the efficacy of the intervention in modifying smoking behavior and emotional distress; and (c) collect additional information to inform a subsequent randomized clinical trial.

Conditions

• Tobacco Smoking

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive-Behavioral Smoking Cessation	Participants will be provided with six individualized smoking cessation counseling sessions designed to help them prepare to quit, set a quit date, behaviorally manage early abstinence, and to resume cessation upon lapse.
BIOLOGICAL	Heart Rate Variability Biofeedback	Participants will be provided with seven individualized trainings in resonance breathing using biofeedback to help improve self-regulation.
DRUG	Nicotine patch	All participants will be offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.

Timeline

• Start date: 2021-11-29
• Primary completion: 2023-06-15
• Completion: 2023-06-15
• First posted: 2022-02-04
• Last updated: 2024-05-01
• Results posted: 2024-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study