Phase 2
N=28
Heart Rate Variability Biofeedback for Smoking Cessation Treatment
Tobacco Smoking
Bottom Line
View on ClinicalTrials.gov: NCT05224050 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Intervention Feasibility: Participant Attendance — 5.32 Sessions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cognitive-Behavioral Smoking Cessation (Behavioral); Heart Rate Variability Biofeedback (Biological); Nicotine patch (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intervention Feasibility: Participant Attendance |
5.32 | — |
| PRIMARY Intervention Feasibility: Participant Practice Adherence |
8.01 | — |
| PRIMARY Intervention Feasibility: Participant Ratings of Effectiveness |
3.02; 3.29; 2.80 | — |
| PRIMARY Intervention Feasibility: Participant Ratings of Appropriateness |
3.46; 3.68; 3.28 | — |
| PRIMARY Intervention Feasibility: Participant Ratings of Ease of the Intervention |
2.70; 2.58; 2.73 | — |
| PRIMARY Intervention Feasibility: Interventionist Ratings of Technical Issues |
117 | — |
| PRIMARY Intervention Acceptability: Participant Rating of Satisfaction and Liking |
3.24; 3.68; 3.45 | — |
| SECONDARY Changes in Total Emotional Distress |
12.50; 15.44; 18.16; 21.50; 3.39; 3.15 | 0.40 |
| SECONDARY Changes in Smoking Behavior: Quit Day Abstinence |
8 | — |
| SECONDARY Changes in Smoking Behavior: Sustained Smoking Cessation |
3 | — |
| SECONDARY Changes in Smoking Behavior: Reduced Smoking Rate |
14.73; 1.14; 1.09; 1.12; 3.30 | <0.001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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 condition or medication use that may be contraindicated for participation in heart rate variability biofeedback training or confound autonomic parameters: Being overweight or obese (i.e., body mass index > 35); Severe asthma or breathing problems (e.g., chronic obstructive pulmonary disease, emphysema, bronchitis); currently pregnant or lactating or plans to become pregnant in the next 4 months; Autoimmune disorder (e.g., multiple sclerosis; under or overactive thyroid); Neurodegenerative disorder (e.g., Alzheimer's disease, Parkinson's disease); Current use of a psychotropic medication or use of other medication that may affect the cardiovascular system (e.g., mood stabilizers, anti-psychotics, monoamine oxidase inhibitors, tricyclics, beta blockers, benzodiazepines; patients taking selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors will be enrolled if on a stable regimen for at least 6 weeks); History of heart murmur or arrhythmia; Pacemaker or other implanted cardiac devices; Heart disease; or Abnormal heart or respiratory parameters including respiration rate > 20 breaths per minute, extra systoles, or hypertension (e.g., blood pressure reading ≥ 140/90; this may be determined following baseline assessment. Importantly, the presence of any of these exclusion factors, if unknown to the participant would not put them at any risk if they participated in the study, it would simply make the cardiovascular data more difficult (if not impossible) to process and interpret, and
- 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
Data sourced from ClinicalTrials.gov (NCT05224050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.