NCT05224050: HRVB-SCT

Heart Rate Variability Biofeedback for Smoking Cessation Treatment

Completed Phase 2 Results posted Last updated 1 May 2024

What this trial tests

Phase 2 trial testing Cognitive-Behavioral Smoking Cessation in Tobacco Smoking in 28 participants. Completed in 15 June 2023.

Timeline

29 November 2021

Primary endpoint
15 June 2023

15 June 2023

Quick facts

Lead sponsor	Rutgers, The State University of New Jersey
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	29 November 2021
Primary completion	15 June 2023
Estimated completion	15 June 2023
Sites	1 location across United States

Drugs / interventions tested

• Cognitive-Behavioral Smoking Cessation
• Heart Rate Variability Biofeedback — full drug profile →
• Nicotine patch (nicotine-patch) — full drug profile →

Conditions studied

• Tobacco Smoking — all drugs for Tobacco Smoking →

Sponsor

Rutgers, The State University of New Jersey

Who can join

Adults 21 to 50, any sex, with Tobacco Smoking. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Intervention Feasibility: Participant Attendance Primary · 6 weeks

Number of intervention sessions attended out of 7 possible sessions.

Group	Value	95% CI
Intent-to-treat Sample	5.32	± 2.28

Intervention Feasibility: Participant Practice Adherence Primary · 6 weeks

Time (in minutes) spent practicing the breathing intervention

Group	Value	95% CI
Intent-to-treat Sample	8.01	± 6.03

Intervention Feasibility: Participant Ratings of Effectiveness Primary · Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit), and Week 16 (i.e., 3-MFU)

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.

Group	Value	95% CI
Week 1 (Treatment Initiation)	3.02	± 0.59
Week 6 (End of Treatment)	3.29	± 0.59
Week 16 (3-MFU)	2.80	± 0.90

Intervention Feasibility: Participant Ratings of Appropriateness Primary · Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit), and Week 16 (i.e., 3-MFU)

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.

Group	Value	95% CI
Week 1 (Treatment Initiation)	3.46	± 0.51
Week 6 (End of Treatment)	3.68	± 0.47
Week 16 (3-MFU)	3.28	± 0.73

Intervention Feasibility: Participant Ratings of Ease of the Intervention Primary · Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit) and Week 16 (i.e., 3-MFU)

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.

Group	Value	95% CI
Week 1 (Treatment Initiation)	2.70	± 0.58
Week 6 (End of Treatment)	2.58	± 0.51
Week 16 (3-MFU)	2.73	± 0.65

Intervention Feasibility: Interventionist Ratings of Technical Issues Primary · 6 weeks

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.

Group	Value	95% CI
Interventionist Reports of Technical Issues	117

Intervention Acceptability: Participant Rating of Satisfaction and Liking Primary · Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit) and Week 16 (i.e., 3-MFU)

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.

Group	Value	95% CI
Week 1 (Treatment Initiation)	3.24	± 0.56
Week 6 (End of Treatment)	3.68	± 0.33
Week 16 (3-MFU)	3.45	± 0.62

Changes in Total Emotional Distress Secondary · Week 0, Week 5, Week 6, and Week 16 (i.e., Baseline, 2-weeks Post-Quit, 1-Month Post-Quit, 3-MFU)

Self-reported change in emotional distress was evaluated via the 21-item, Depression, Anxiety and Stress Scale (DASS-21). The DASS-21 is composed of three self-report scales that measure the emotional states of depression, anxiety and stress. Items are rated on a Likert-type scale (0=Did not apply to me at all, to 3=Applied to me very much, or most of the time). Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items. The severity ratings are as follows Depression: Normal 0-4, Mild: 5-6, Moderate: 7-10, Severe: 11-13, Extremely Severe: 14-21. Anxie

DASS-21 Total score

Group	Value	95% CI
Baseline	12.50	± 9.76
2-Weeks Post-Quit	15.44	± 7.38
1-Month Post-Quit	18.16	± 10.68
3-MFU	21.50	± 11.70

DASS-21 Depression score

Group	Value	95% CI
Baseline	3.39	± 3.28
2-Weeks Post-Quit	3.15	± 2.82
1-Month Post-Quit	4.89	± 4.18
3-MFU	7.06	± 4.36

DASS-21 Anxiety score

Group	Value	95% CI
Baseline	3.57	± 3.67
2-Weeks Post-Quit	4.80	± 2.63
1-Month Post-Quit	5.11	± 3.26
3-MFU	5.69	± 4.09

DASS-21 Stress score

Group	Value	95% CI
Baseline	5.54	± 4.48
2-Weeks Post-Quit	7.49	± 3.42
1-Month Post-Quit	8.16	± 4.66
3-MFU	8.75	± 4.85

Changes in Smoking Behavior: Quit Day Abstinence Secondary · Week 3 (i.e., Quit Date)

Quit day abstinence was assessed via self-reported smoking abstinence on Quit Day and verified via carbon monoxide (CO) analysis of breath sample (CO \< 8ppm).

Group	Value	95% CI
Quit Date	8

Changes in Smoking Behavior: Sustained Smoking Cessation Secondary · Week 16 (i.e., 3-MFU)

Sustained smoking cessation was assessed via self-reported abstinence at 3-months post-quit) and verified via carbon monoxide (CO) analysis (CO \< 8ppm) and salivary cotinine levels (\<10 ng/mL).

Group	Value	95% CI
3-Month Follow Up	3

Changes in Smoking Behavior: Reduced Smoking Rate Secondary · 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)

Cigarettes smoked per day (CPD) assessed via self-report responses on the Timeline Followback interview were used to measure changes in smoking behavior from Baseline through Quit Date, 2-weeks post-quit, 1-month post-quit, and 3-months follow up.

Group	Value	95% CI
Baseline	14.73	± 7.09
Quit Date	1.14	± 2.77
2-Weeks Post-Quit	1.09	± 2.00
1-Month Post-Quit	1.12	± 2.80
3-Month Follow Up	3.30	± 3.67

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.