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.
The present investigation is an open trial investigating the feasibility and acceptability of heart rate variability biofeedback smoking cessation treatment (HRVB-SCT) for individuals who smoke cigarettes. Significant findings will also support the expansion of HRVB as a transdiagnostic treatment adjunct that alters cardiac vagal functioning to promote emotional and behavioral regulation, changing the status quo of cognitive-behavioral intervention approaches and decreasing the health and economic burden of smokers who suffer from emotional distress. The goals are to: (a) assess the feasibility and acceptability of the HRVB-SCT intervention (b) assess the efficacy of the intervention in modifying smoking behavior and emotional distress; and (c) collect additional information to inform a subsequent randomized clinical trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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.
Participants will be provided with seven individualized trainings in resonance breathing using biofeedback to help improve self-regulation.
All participants will be offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.
Rutgers, School of Arts and Sciences, One Spring Street
New Brunswick, New Jersey, United States
Intervention Feasibility: Participant Attendance
Number of intervention sessions attended out of 7 possible sessions.
Time frame: 6 weeks
Intervention Feasibility: Participant Practice Adherence
Time (in minutes) spent practicing the breathing intervention
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: Week 1 (i.e., treatment initiation), Week 6 (i.e., end of treatment/1-month post-quit) and Week 16 (i.e., 3-MFU)
Changes in Total Emotional Distress
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. Anxiety: Normal: 0-3, Mild: 4-5, Moderate: 6-7, Severe: 8-9, Extremely Severe: 10-21. Stress: Normal: 0-7, Mild: 8-9, Moderate: 10-12, Severe: 13-16, Extremely Severe: 17-21. Total scores are computed by summing the subscales. Total scores for the DASS-21 range from 0-63. For all scales, higher scores are indicative of greater emotional distress and less change in total distress symptoms over time.
Time frame: 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
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).
Time frame: Week 3 (i.e., Quit Date)
Changes in Smoking Behavior: Sustained Smoking Cessation
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).
Time frame: Week 16 (i.e., 3-MFU)
Changes in Smoking Behavior: Reduced Smoking Rate
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.
Time frame: 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)