Heart Rate Variability Biofeedback for Smoking Cessation (HRVB-SCT)
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|ClinicalTrials.gov Identifier: NCT03972137|
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : June 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Smoking||Behavioral: Cognitiive-Behaivoral Smoking Cessation Behavioral: Heart Rate Variability Biofeedback Drug: Nicotine patch||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants will be assigned to individualized smoking cessation, nicotine replacement therapy patch, and heart rate variability biofeedback.|
|Masking:||None (Open Label)|
|Masking Description:||This is an open trial with all participants receiving what will become the 'active intervention' in a subsequent randomized clinical trial.|
|Official Title:||Development and Pilot Investigation of Heart Rate Variability Biofeedback for Smoking Cessation|
|Actual Study Start Date :||April 24, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||May 31, 2020|
All participants in this open trial will receive individualized cognitive-behavioral smoking cessation treatment, up to 8 weeks of the transdermal nicotine patch, and individualized heart rate variability biofeedback.
Behavioral: Cognitiive-Behaivoral Smoking Cessation
Participants will be provided with five 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.
Behavioral: Heart Rate Variability Biofeedback
Heart Rate Variability Biofeedback: All participants will be provided with individualized training in resonance breathing using biofeedback to help improve self-regulation.
Drug: Nicotine patch
All participants will be offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.
- Intervention Feasibility: Participant Attendance and Adherence [ Time Frame: Weekly from Week 1 through Week 7 ]A composite index of attendance and adherence (e.g., homework completion) will be used to index intervention feasibility, from Week 1 through Week 7 (i.e., end-of-treatment).
- Intervention Feasibility, Treatment Initiation: Participant Ratings of Perceived Effectiveness and Appropriateness [ Time Frame: Week 1 ]Feasibility will be assessed via participant ratings of perceived effectiveness of the intervention in terms of helping them quit and manage emotional distress, ease of use, and perceived appropriateness of the intervention, upon treatment initiation.
- Intervention Feasibility, End-of Treatment: Participant Ratings of Perceived Effectiveness and Appropriateness [ Time Frame: Week 7, i.e., end-of-treatment ]Feasibility will be assessed via participant ratings of perceived effectiveness of the intervention in terms of helping them quit and manage emotional distress, ease of use, and perceived appropriateness of the intervention, upon completing the intervention.
- Intervention Acceptability, Treatment Initiation: Participant Ratings of Satisfaction and Liking [ Time Frame: Week 1 ]Acceptability of the intervention will be based on participant ratings of satisfaction and liking of intervention components, upon treatment initiation.
- Intervention Acceptability, End-of-Treatment: Participant Ratings of Satisfaction and Liking [ Time Frame: Week 7, i.e., end-of-treatment ]Acceptability of the intervention will be based on participant ratings of satisfaction and liking of intervention components, upon completing the intervention at Week 7.
- Changes in Smoking Rate [ Time Frame: Week 0 (i.e., baseline), Week 3 (i.e., quit date), Week 5 (i.e., 2-weeks post-quit), Week 7 (i.e., 1-month post-quit), and Week 16 (i.e., 3-months post-quit) ]Change in smoking behavior from Week 0 (i.e., baseline) through Week 16 (i.e., 3-months post-quit) will be assessed via the well established Timeline Followback calendar interview.
- Smoking Cessation [ Time Frame: Week 3 (i.e, Quit date), Week 5 (i.e., 2-weeks post-quit), Week 7 (i.e., 1-month post-quit), and Week 16 (i.e., 3-months post-quit) ]Smoking cessation will be based upon self-report and carbon monoxide analysis of breath sample (<5 ppm) at Week 3, i.e., the quit date, and at Week 5, Week 7, and Week 16, corresponding with 2-weeks, 1-month, and 3-months post-quit date. Participants whose abstinence is verified via carbon monoxide analysis of breath at Week 16, which occurs approximately five weeks following transdermal nicotine patch termination for those who use the full 8-week course, will provide a saliva sample for cotinine testing to biologically verify abstinence (<12 ng/mL). Participants whose carbon monoxide analysis of breath sample (I.e., Weeks 3, 5, and 7) or cotinine analysis (Week 16) do not indicate abstinence will be coded as smoking.
- Change in Total Emotional Distress [ Time Frame: Week 0, Week 5, Week 7, Week 16, i.e., baseline, 2-weeks, 1-month, and 3-months post-quit ]Self-reported changes, over time, in total emotional distress will be evaluated via the 21-item, Depression, Anxiety and Stress Scale from Week 0 (i.e., baseline) to Week 5 Week 7, and Week 16, corresponding with 2-weeks, 1-month, and 3-months post-quit. Items will be 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972137
|Contact: Teresa M Leyro, Ph.D.||email@example.com|
|Contact: Mindy Kibbeyfirstname.lastname@example.org|
|United States, New Jersey|
|Rutgers, School of Arts and Sciences, One Spring Street||Recruiting|
|New Brunswick, New Jersey, United States, 08901|
|Contact: Teresa Leyro, Ph.D. 732-659-4283 ext 6172231024 email@example.com|
|Contact: Mindy Kibbey 732-659-4283 firstname.lastname@example.org|