Phase 2
Completed N=10
Heart Rate Variability Biofeedback for Smoking Cessation
Tobacco Smoking
Source: ClinicalTrials.gov NCT03972137 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Intervention Feasibility: Participant Attendance — 6.30; 8.71 Sessions
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intervention Feasibility: Participant Attendance |
6.30; 8.71 | — |
| PRIMARY Intervention Feasibility: Participant Ratings of Effectiveness |
3.03; 3.19 | — |
| PRIMARY Intervention Feasibility: Participant Ratings of Appropriateness |
3.61; 2.87 | — |
| PRIMARY Intervention Feasibility: Participant Ratings of Ease of the Intervention |
2.4; 1.58 | — |
| PRIMARY Intervention Acceptability: Participant Ratings of Satisfaction and Liking |
3.24; 3.52 | — |
| SECONDARY Number of Participants With Self-Reported Abstinence, Cotinine Verified Abstinence, and Carbon Monoxide Analysis of Breathe Sample (CO < 8ppm) |
6; 4; NA; 4; 2; 4 | — |
| SECONDARY Cigarettes Smoked Per Day |
11.56; 0.14; 0 | .003 sig |
| SECONDARY Change in Total Emotional Distress |
39.9; 23.5; 12.2; 13.75; 11.5; 5.0 | .010 sig |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03972137). 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. Informational only — not medical advice.