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| ID | Type | Description | Link |
|---|---|---|---|
| 101031962 | Other Grant/Funding Number | European Commission Marie Skłodowska-Curie |
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This study aims to investigate the associations between emotion regulation ability, stress-induced neural activity changes, and susceptibility to relapse in smokers attempting to quit. Participants will undergo assessments of emotion regulation, neural activity via quantitative electroencephalography (qEEG), and stress responses before and during a 24-hour nicotine abstinence period. They will then participate in a computerized smoking cessation intervention, and their abstinence status will be monitored for 6 months.
The study will examine the unique and interactive effects of emotion regulation ability (a trait-like vulnerability factor) and biomarkers of stress responses (emotion regulation and neural activation changes) prior to smoking cessation, on cravings, abstinence adherence, and response to a smoking cessation intervention.
The study will be divided into three main phases:
The primary outcomes are maintenance of abstinence, smoking lapses, and time to relapse. Secondary outcomes include changes in emotion regulation, neural activity, stress responses, withdrawal symptoms, and cue-induced cravings.
The study hypothesizes that smokers who fail to maintain long-term abstinence will exhibit enhanced stress-induced high-frequency qEEG oscillations, disrupted connectivity in emotion regulation brain regions, and emotion regulation deficits. It is also hypothesized that the interplay between these measures will predict smoking cessation outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smoking Cessation Intervention | Experimental | Participants receive Flexiquit, an avatar-led computerized smoking cessation program. Flexiquit is a self-delivered app providing: motivational interviewing, psychoeducation on addiction/withdrawal, cognitive-behavioral strategies for cravings, relapse prevention, stress/emotion regulation skills. Delivered over 6 months starting Day 2 after initial assessments. Adherence monitored. Biochemical verification of abstinence at 3 and 6 months post-quit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexiquit Computerized Smoking Cessation Program | Behavioral | Flexiquit is an avatar-led, self-directed computerized program delivering evidence-based techniques to assist with smoking cessation. It includes motivational interviewing, psychoeducation on nicotine addiction, cognitive-behavioral strategies for coping with cravings, relapse prevention, and stress/emotion regulation skills training. Participants receive the program over 6 months and their adherence is monitored. The program provides tailored feedback to support abstinence. |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of Abstinence | Defined as biochemically verified (via expired carbon monoxide) continuous abstinence from smoking for the full 6 month period after the quit date | Measured at 3 and 6 month follow-ups |
| Time to First Smoking Lapse | Defined as the number of days between the quit date and the first smoking lapse (smoking even a puff of a cigarette). Smoking lapses will be monitored continuously via self-report. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Withdrawal Symptoms | Assessed via standardized withdrawal symptom questionnaires at baseline and after 24 hours of abstinence. | Baseline, 24 hours |
| Emotion Regulation | Measured via heart rate variability before and after stress exposure at baseline and 24-hour timepoints |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Panos Zanos, Ph.D. | Contact | +35722892243 | zanos.panos@ucy.ac.cy |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Applied Neuroscience | Recruiting | Nicosia | 2100 | Cyprus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28845999 | Background | Karekla M, Panayiotou G, Collins BN. Predictors of urge to smoke under stressful conditions: An experimental investigation utilizing the PASAT-C task to induce negative affect in smokers. Psychol Addict Behav. 2017 Nov;31(7):735-743. doi: 10.1037/adb0000309. Epub 2017 Aug 28. | |
| 32383736 | Background | Karekla M, Savvides SN, Gloster A. An Avatar-Led Intervention Promotes Smoking Cessation in Young Adults: A Pilot Randomized Clinical Trial. Ann Behav Med. 2020 Oct 1;54(10):747-760. doi: 10.1093/abm/kaaa013. |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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Intervention Model: Single Group Assignment This is a single-arm study where all participants will receive the same smoking cessation intervention after completing the initial assessments.
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| Baseline, 24 hours |
| Neural Activity | Quantitative EEG spectral power and coherence between brain regions involved in emotion regulation assessed at baseline and after 24-hour abstinence. | Baseline, 24 hours |
| Stress Responses | Salivary cortisol levels measured before and after stress exposure at baseline and 24-hour timepoints | Baseline, 24 hours |
| D001523 |
| Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |