Heart Rate Variability Biofeedback for Smoking Cessation Treatment

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)

Population: Of the N=28 participants who enrolled in the study, n=27 had available data at Week 1 for this measure; Of the n=19 who completed treatment, n=18 had available data at Week 6; n=16 completed this measure at their 3-month follow up.

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

Population: There was a total of 291 intervention sessions where instances of technical issues could have occurred and been reported.

Number of intervention sessions attended out of 7 possible sessions.

Time frame: 6 weeks

Population: Data on the Intent-to-treat N=28 participants who completed the baseline session and were enrolled in the study.

Time (in minutes) spent practicing the breathing intervention

Time frame: 6 weeks

Population: Data on the Intent-to-treat N=28 participants who completed the baseline session and were enrolled in the study.

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)

Population: Of the N=28 participants who enrolled in the study, n=26 had available data at Week 1 for this measure; Of the n=19 who completed treatment, n=17 had available data at Week 6; n=16 completed this measure at their 3-month follow up.

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.

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)

Population: Of the N=28 participants who enrolled in the study, n=27 had available data at Week 1 for this measure; Of the n=19 who completed treatment, n=18 had available data at Week 6; n=16 completed this measure at their 3-month follow up.

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)

Population: Of the N=28 participants who enrolled in the study, n=27 had available data at Week 1 for this measure; Of the n=19 who completed treatment, n=18 had data available at Week 6; n=16 completed this measure at their 3-month follow up.

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)

Population: Of the N=28 who were eligible and initiated treatment, n=22 attended their quit date.

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)

Population: Of the N=28 participants who were eligible and attended their baseline session, n=22 attended their quit date, n=20 attended their 2-weeks post-quit session, n=19 attended their 1-month post-quit session, and n=16 attended their 3-month follow up.

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)

Population: Of the N=28 who were eligible and initiated treatment, n=16 attended their 3-month follow-up session.

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)

Population: Of the N=28 participants who were eligible and attended their baseline session, n=20, n=19, and n=16 attended and completed this measure at their 2-weeks post-quit, 1-month post-quit, and 3-month follow up sessions.