Heart Rate Variability Biofeedback for Smoking Cessation Treatment

NCT05224050 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: Pro20190015395R34DA043751-03
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Smoking

Keywords

Smoking Cessation; Heart Rate Variability Biofeedback

Outcome Measures

Primary Outcomes (7)

• Intervention Feasibility: Participant Attendance

  Number of intervention sessions attended out of 7 possible sessions.

  6 weeks

• Intervention Feasibility: Participant Practice Adherence

  Time (in minutes) spent practicing the breathing intervention

  6 weeks

• Intervention Feasibility: Participant Ratings of Effectiveness

  Effectiveness was assessed via self-report ratings on four items assessing the intervention in terms of helping them quit and manage emotional distress, rated on a 0=completely disagree to 4=completely agree Likert-type scale. Mean total scores were computed by averaging the items for each respective timepoint. Mean total scores range from 0-4. For this scale, higher scores are indicative of greater perceived intervention efficacy.

  Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit), and Week 16 (i.e., 3-MFU)

• Intervention Feasibility: Participant Ratings of Appropriateness

  Appropriateness was assessed via self-report ratings on two items assessing the intervention in terms of comprehension and fit, rated on a 0=completely disagree to 4=completely agree Likert-type scale. Mean total scores were computed by averaging the items for each respective timepoint. Mean total scores range from 0-4. For this scale, higher scores are indicative of greater perceived intervention appropriateness.

  Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit), and Week 16 (i.e., 3-MFU)

• Intervention Feasibility: Participant Ratings of Ease of the Intervention

  Ease of the Intervention was assessed via self-report ratings on three items assessing ease of use and fit into daily lifestyle, rated on a 0=completely disagree to 4=completely agree Likert-type scale. Mean total scores were computed by averaging the items for each respective timepoint. Mean total scores range from 0-4. For this scale, higher scores are indicative of greater perceived ease of the intervention and fit into daily lifestyle.

  Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit) and Week 16 (i.e., 3-MFU)

• Intervention Feasibility: Interventionist Ratings of Technical Issues

  The intervention used several pieces of technology, including remote session delivery via Zoom, smartphone assisted carbon monoxide (CO) monitor and HRVB devices, remote survey administration, as well as in-person use of biofeedback and physiological monitoring equipment. Technological limitations were assessed via self-report items documenting incidences of technical issues during intervention sessions and their related effects on intervention delivery. Items include Yes/No and open-text responses.

  6 weeks

• Intervention Acceptability: Participant Rating of Satisfaction and Liking

  Satisfaction and liking will be assessed via self-report items regarding satisfaction with learning the intervention, liking the intervention, breathing techniques, nicotine replacement, and recommending the intervention to others. Items are rated on a 0=completely disagree to 4=completely agree Likert-type scale. Mean total scores were computed by averaging the items for each respective timepoint. Mean total scores range from 0-4. For this scale, higher scores are indicative of greater satisfaction and liking of the intervention and greater perceived intervention acceptability.

  Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit) and Week 16 (i.e., 3-MFU)

Secondary Outcomes (4)

• Changes in Total Emotional Distress

  Week 0, Week 5, Week 6, and Week 16 (i.e., Baseline, 2-weeks Post-Quit, 1-Month Post-Quit, 3-MFU)

• Changes in Smoking Behavior: Quit Day Abstinence

  Week 3 (i.e., Quit Date)

• Changes in Smoking Behavior: Sustained Smoking Cessation

  Week 16 (i.e., 3-MFU)

• Changes in Smoking Behavior: Reduced Smoking Rate

  Week 0, Week 3, Week 5, Week 6, and Week 16 (i.e., Baseline, Quit Date, 2-Weeks Post-Quit, 1-Month Post-Quit, 3-Month follow up)

Study Arms (1)

Heart Rate Variability Biofeedback-Smoking Cessation Therapy (HRVB-SCT)

EXPERIMENTAL

All participants in this open trial will receive individualized training in resonance breathing using biofeedback to help improve self-regulation (HRVB), cognitive-behavioral smoking cessation treatment (SCT), and up to 8-weeks of the transdermal nicotine patch (NRT).

Behavioral: Cognitive-Behavioral Smoking Cessation; Biological: Heart Rate Variability Biofeedback; Drug: Nicotine patch

Interventions

Cognitive-Behavioral Smoking Cessation BEHAVIORAL

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.

Also known as: Cognitive-behavioral therapy, Smoking cessation counseling

Heart Rate Variability Biofeedback-Smoking Cessation Therapy (HRVB-SCT)

Heart Rate Variability Biofeedback BIOLOGICAL

Participants will be provided with seven individualized trainings in resonance breathing using biofeedback to help improve self-regulation.

Also known as: Biofeedback, Respiratory biofeedback

Heart Rate Variability Biofeedback-Smoking Cessation Therapy (HRVB-SCT)

Nicotine patch DRUG

All participants will be offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.

Also known as: Transdermal nicotine patch, Nicotine replacement therapy

Heart Rate Variability Biofeedback-Smoking Cessation Therapy (HRVB-SCT)

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 21-50
• Smoking ≥ 5 cigarettes, daily, for at least two years
• Expired carbon monoxide analysis of breath sample ≥8 ppm
• A score of \> 5 on the Readiness to Quit Ladder (i.e., desire to quit smoking within the next 6 months)
• Ability to read and speak English fluently
• Computer and Smartphone proficient

You may not qualify if:

• Use of other tobacco or nicotine products for recreation or to aid in cessation or use of medication to aid in smoking cessation or currently receiving counseling for smoking cessation
• Endorsement of current or past psychotic or manic symptoms indicative of bipolar spectrum or schizophrenia spectrum disorders and/or current suicidal or homicidal ideation
• Self-reported pending legal issue with potential to result in incarceration
• Plan to move from the New Brunswick, New Jersey area within the next 6 months
• Inability to provide written informed consent
• Current evidence of another substance use disorder
• Severe visual or hearing impairments
• Self-reported medical issues of potential concern to nicotine patch users (i.e., unstable angina pectoris, myocardial infarction, or significant cardiac arrhythmia (including atrial fibrillation) in the past 90 days

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Rutgers, School of Arts and Sciences, One Spring Street

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (1)

• Leyro TM, Buckman JF, Bates ME. Theoretical implications and clinical support for heart rate variability biofeedback for substance use disorders. Curr Opin Psychol. 2019 Dec;30:92-97. doi: 10.1016/j.copsyc.2019.03.008. Epub 2019 Apr 2.

  PMID: 31055246 BACKGROUND

MeSH Terms

Conditions

Tobacco Smoking; Smoking Cessation

Interventions

Cognitive Behavioral Therapy; Biofeedback, Psychology; Tobacco Use Cessation Devices; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use; Health Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics; Feedback, Psychological; Drug Therapy

Results Point of Contact

• Title: Dr. Teresa Leyro
• Organization: Rutgers, The State University of New Jersey

[email protected]

848-445-2090

Study Officials

• Teresa M, Leyro, Ph.D.

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open trial with all participants receiving the experimental intervention (HRVB) in addition to smoking cessation therapy and nicotine replacement therapy patch.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All participants will receive individualized smoking cessation therapy (SCT), nicotine replacement therapy patch (NRT) and heart rate variability biofeedback (HRVB)

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: February 4, 2022
• Study Start: November 29, 2021
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: May 1, 2024
• Results First Posted: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)