Heart Rate Variability Biofeedback for Smoking Cessation

NCT03972137 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2018001848R34DA043751
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Open trial of heart rate variability biofeedback as an adjunct to individualized smoking cessation counseling (SCT) plus transdermal nicotine replacement patch (NRT) in smokers with elevated emotional distress.

Conditions

Tobacco Smoking

Keywords

Smoking Cessation; Heart rate variability biofeedback

Outcome Measures

Primary Outcomes (5)

• Intervention Feasibility: Participant Attendance

  Number of intervention sessions attended out of 10 possible sessions.

  7 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. Higher scores on this scale are indicative of greater perceived intervention efficacy. Mean scores obtained following the first intervention session and 3-month follow-up session are reported.

  Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)

• 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. Higher scores on this scale are indicative of greater perceived intervention appropriateness. Mean scores obtained following the first intervention session and 3-month follow-up session are reported.

  Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)

• 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. Higher scores on this scale are indicative of greater perceived ease of the intervention and fit into daily lifestyle. Mean scores obtained following the first intervention session and 3-month follow-up session are reported.

  Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)

• Intervention Acceptability: Participant Ratings of Satisfaction and Liking

  Satisfaction and liking were assessed via self-report ratings on five items assessing satisfaction with learning the intervention, liking the intervention, breathing techniques, nicotine replacement, and recommending the intervention to friends, rated on a 0=completely disagree to 4=completely agree Likert-type scale. Higher scores on this scale are indicative of greater intervention acceptability. Mean scores obtained following the first intervention session and 3-month follow-up session are reported.

  Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)

Secondary Outcomes (3)

• Number of Participants With Self-Reported Abstinence, Cotinine Verified Abstinence, and Carbon Monoxide Analysis of Breathe Sample (CO < 8ppm)

  Week 3 (i.e., Quit Date) and Week 16 (i.e., 3-month follow-up)

• Cigarettes Smoked Per Day

  Week 0 (i.e., baseline), Week 3 (i.e., Quit Date) and Week 16 (i.e., 3-month follow-up)

• Change in Total Emotional Distress

  Week 0 (i.e., baseline), Week 5 (i.e., 2-weeks post-quit), Week 7 (i.e., 1-month post-quit) and Week 16 (i.e., 3-month follow-up)

Study Arms (1)

Heart Rate Variability Biofeedback-Smoking Cessation Therapy

EXPERIMENTAL

All participants in this open trial received individualized cognitive-behavioral smoking cessation treatment (SCT), up to 8 weeks of the transdermal nicotine patch (NRT) and individualized heart rate variability biofeedback (HRVB).

Behavioral: Cognitive-Behavioral Smoking Cessation; Behavioral: Heart Rate Variability Biofeedback (HRVB); Drug: Transdermal Nicotine patch

Interventions

Cognitive-Behavioral Smoking Cessation BEHAVIORAL

Participants were 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 (SCT)

Heart Rate Variability Biofeedback-Smoking Cessation Therapy

Heart Rate Variability Biofeedback (HRVB) BEHAVIORAL

All participants were provided with individualized training in resonance breathing using biofeedback to help improve self-regulation.

Also known as: Biofeedback, Respiratory biofeedback

Heart Rate Variability Biofeedback-Smoking Cessation Therapy

Transdermal Nicotine patch DRUG

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

Also known as: Nicotine patch, Nicotine replacement therapy (NRT)

Heart Rate Variability Biofeedback-Smoking Cessation Therapy

Eligibility Criteria

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

You may qualify if:

• Smoking ≥5 cigarettes, daily, for at least two years
• expired carbon monoxide analysis of breath sample ≥8 ppm
• elevated affective distress
• motivation to quit
• computer proficient

You may not qualify if:

• current use of other tobacco or nicotine products for recreation or to aid in cessation, use of pharmacological intervention for cessation, or current enrollment in a psychosocial intervention 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
• inability to provide written informed consent
• current evidence of another substance use disorder
• severe visual or hearing impairments
• self-reported medical condition or medication use that may be contraindicated for participation in a HRVB or confound autonomic parameters:
• self-reported medical issues of potential concern to nicotine patch users

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

tml124@psych.rutgers.edu

848-445-2090

Study Officials

• Teresa Leyro, Ph.D.

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open trial with all participants receiving what will become the 'active intervention' in a subsequent randomized clinical trial.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: June 3, 2019
• Study Start: April 24, 2019
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: August 25, 2020
• Results First Posted: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)