Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2026-01-28 @ 9:28 PM
Study NCT ID:
NCT06544057
Status:
RECRUITING
Last Update Posted:
2024-11-29
First Post:
2024-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-time eCounselling for Nicotine Addiction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D000072137', 'term': 'Vaping'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012907', 'term': 'Smoking'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-07-11', 'size': 56504, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-07-11T07:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "The blinding procedure aims to minimise bias by ensuring the outcome assessor, a member of our research team, remains unaware of participants' treatment allocation (Intervention or WLCG). This 'Single-Blind' design involves blinding the internal team's outcome assessor, who evaluates study endpoints without knowledge of participants' group assignments. To uphold blinding integrity, outcome assessors refrain from engaging with participants or study personnel. Participants and intervention administrators are not blinded due to the intervention nature"}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This was a two-arm Block randomised pilot trial with study centres using block randomisation comparing Wait-list and Active.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2024-07-12', 'studyFirstSubmitQcDate': '2024-08-05', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abstinence status', 'timeFrame': '1 week post study: 7 days retrospective', 'description': 'This is a binary indicator, suggesting whether or not participants are abstinent at point of questioning'}, {'measure': 'Nicotine consumption (cigarettes, units)', 'timeFrame': 'Baseline; 6 weeks after the intervention', 'description': 'Unit: Number of cigarettes consumed, on average, per day'}, {'measure': 'Nicotine consumption (cigarettes, time)', 'timeFrame': 'Baseline; 6 weeks after the intervention', 'description': 'Time: Time spent smoking nicotine, on average, per day'}, {'measure': 'Nicotine consumption (vape, units)', 'timeFrame': 'Baseline; 6 weeks after the intervention', 'description': "Unit: Number of 15-minute 'episodes' of vaping, on average, per day"}, {'measure': 'Nicotine consumption (vape, time)', 'timeFrame': 'Baseline; 6 weeks after the intervention', 'description': 'Time: Time spent vaping nicotine, on average, per day'}], 'secondaryOutcomes': [{'measure': 'Dependence and Craving (CDS)', 'timeFrame': 'Baseline; 6 weeks after the intervention', 'description': 'Cigarette dependence and craving experiences will be assessed using the Cigarette Dependence Scale (CDS), which measures various aspects of nicotine dependence, including withdrawal symptoms, desire to quit, time spent using, and the effects of consumption on activities. The scale has possible values of 1, 2, 3, 4, 5. On this ordinal scale, higher values denote stronger agreement.'}, {'measure': 'Dependence and Craving (EDS)', 'timeFrame': 'Baseline; 6 weeks after the intervention', 'description': 'The (Electronic) e-Cigarette Dependence Scale (EDS) captures similar dimensions of dependence specific to e-cigarette use and will be administered at the same time points as the Cigarette Dependence Scale (CDS), which measures various aspects of nicotine dependence, including withdrawal symptoms, desire to quit, time spent using, and the effects of consumption on activities. This scale measures the level of nicotine dependence in those who use e-cigarettes or vapes. The scale has possible values of 1, 2, 3, 4, 5. On this ordinal scale, higher values denote stronger agreement.'}, {'measure': 'Readiness to Quit', 'timeFrame': 'Baseline; Every week during the intervention', 'description': 'Participants\' readiness to quit smoking will be assessed using the contemplation ladder (CL), which measures their current stage of change in the quitting process. The Contemplation Ladder (CL) measures readiness to quit using an 11-point Likert scale, ranging from "No thoughts of quitting" (0) to "Taking action to quit" (10). he possible values of the measure were 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11. On this ordinal scale, higher values denote stronger agreement regarding readiness to quit.'}, {'measure': "Perceived Smoking Abstinence Efficacy as assessed by questionnaire measuring participants' confidence in their ability to quit smoking, and their resistance to temptation to relapse", 'timeFrame': 'Baseline; Every week during the intervention', 'description': "The questionnaire comprises items related to positive social situations, negative affect situations, and habitual/craving situations. Responses will be recorded on a 5-point Likert scale ranging from 'Not at all tempted' to 'Extremely tempted'. The possible values of the measure were 1, 2, 3, 4, 5, 6, 7, 8, 9. On this ordinal scale, higher values denote stronger agreement regarding self-efficacy in nicotine abstinence."}, {'measure': 'Decisional balance', 'timeFrame': 'Baseline; Every week during the intervention', 'description': "'Decisional balance' evaluates the pros and cons of nicotine consumption and quitting. This scale measures participant's relative weighing of the pros and cons of smoking/vaping. The possible values of the measure were 1, 2, 3, 4, 5. On this ordinal scale, higher values denote stronger agreement."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smoking cessation', 'Vaping', 'Public health', 'eHealth', 'Nicotine addiction', 'Feasibility'], 'conditions': ['Nicotine Use Disorder']}, 'referencesModule': {'references': [{'pmid': '1935872', 'type': 'BACKGROUND', 'citation': 'Biener L, Abrams DB. The Contemplation Ladder: validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10(5):360-5. doi: 10.1037//0278-6133.10.5.360.'}, {'pmid': '12589389', 'type': 'BACKGROUND', 'citation': 'Etter JF, Le Houezec J, Perneger TV. A self-administered questionnaire to measure dependence on cigarettes: the cigarette dependence scale. Neuropsychopharmacology. 2003 Feb;28(2):359-70. doi: 10.1038/sj.npp.1300030.'}, {'pmid': '29301008', 'type': 'BACKGROUND', 'citation': "Morean ME, Krishnan-Sarin S, Sussman S, Foulds J, Fishbein H, Grana R, O'Malley SS. Psychometric Evaluation of the E-cigarette Dependence Scale. Nicotine Tob Res. 2019 Oct 26;21(11):1556-1564. doi: 10.1093/ntr/ntx271."}, {'pmid': '10170434', 'type': 'BACKGROUND', 'citation': 'Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997 Sep-Oct;12(1):38-48. doi: 10.4278/0890-1171-12.1.38.'}, {'type': 'BACKGROUND', 'citation': 'Abrams, D. B., Herzog, T. A., Emmons, K. M., Linnan, L., & Stages of Change Working Group. (2000). Predicting smoking cessation from intentions and plans: Does type of smoker matter? Health Psychology, 19(1S), 24-33. DOI: 10.1016/j.addicn.2023.100068.'}, {'type': 'BACKGROUND', 'citation': 'Fidancı, I., Sümer, H. C., & Fırat, S. (2017). The role of emotion regulation difficulties and smoking-related cognitions in understanding anxiety and smoking among treatment-seeking smokers. Journal of Cognitive Psychotherapy, 31(3), 227-240'}, {'pmid': '2378287', 'type': 'BACKGROUND', 'citation': 'Velicer WF, Diclemente CC, Rossi JS, Prochaska JO. Relapse situations and self-efficacy: an integrative model. Addict Behav. 1990;15(3):271-83. doi: 10.1016/0306-4603(90)90070-e.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to pilot an eHealth intervention (real-time telecounselling) in nicotine addiction. The main questions it aims to answer are:\n\nIs the intervention likely to be efficacious in preventing an increase in Abstinence? Is the intervention likely to be efficacious in preventing an increase in nicotine consumption? Is the intervention likely to be efficacious in influencing Readiness to quit nicotine? How feasible is the intervention for developing a larger-scale trial?\n\nResearchers will compare a range of outcome measures between the active and control arms, to see if a pilot eHealth intervention can successfully treat nicotine addiction.', 'detailedDescription': 'The goal of this clinical trial is to pilot an eHealth intervention in nicotine addiction (real-time telecounselling) . It will also attempt to better understand the psychology of nicotine addiction and craving regarding consumption behaviour. The main questions it aims to answer are:\n\nIs the intervention likely to be efficacious in preventing an increase in Abstinence? Is the intervention likely to be efficacious in preventing an increase in nicotine consumption? Is the intervention likely to be efficacious in influencing Readiness to quit nicotine? How feasible is the intervention for developing a larger-scale trial?\n\nResearchers will compare outcomes pre and post intervention in the active arm, and also between active and control arms, to ascertain the treatment effect of the intervention on primary (nicotine consumption, abstinence) and secondary (self-efficacy, readiness to quit, decisional balance) measures, in tests of efficacy.\n\nFollowing randomisation, participants will be allocated to either the active arm or the control arm. In the active arm, participants will undergo six weekly sessions of real-time CBT-MI (Cognitive Behavioural Therapy with Motivational Interviewing), with each session lasting approximately 45 to 60 minutes. In the control arm: A Wait List Control Group (WLCG) will denote the comparator, who will undergo screening and assessment only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 18-65 Years old\n2. Self Reported smoking ≥ 5 cigarettes per day, or regular vaper of \\> 0mg nicotine\n3. Desire to quit nicotine consumption\n4. Willing to set a quit date\n5. Able to provide written informed consent to participate -\n\nExclusion Criteria:\n\n1. Enrolled in another behavioural intervention programme\n2. Pregnant, breastfeeding or planning to become pregnant.\n3. Individuals currently experiencing a problematic relationship with alcohol or drugs\n4. Documented Cognitive Impairment\n5. Individuals with a PHQ-9 score of ≥ 14 or a GAD-7 score of \\>12.'}, 'identificationModule': {'nctId': 'NCT06544057', 'briefTitle': 'Real-time eCounselling for Nicotine Addiction', 'organization': {'class': 'OTHER', 'fullName': 'Overcome'}, 'officialTitle': 'Real-time eCounselling for Nicotine Addiction: a Feasibility Study and Pilot RCT', 'orgStudyIdInfo': {'id': 'P-PF-03.24.0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBT-MI', 'description': 'Behavioural Therapy (CBT) with Motivational Interviewing (MI) techniques. It comprises six individual sessions delivered via real-time video (Zoom) on mobile or computer platforms. Sessions last approximately 45 to 60 minutes each.', 'interventionNames': ['Behavioral: CBT-MI']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list', 'description': 'Control group will undergo recruitment and screening and be assigned to a wait-list, to undergo the intervention after the active group. Data collection will continue as in the active arm, to compare with that collected in the active arm'}], 'interventions': [{'name': 'CBT-MI', 'type': 'BEHAVIORAL', 'description': "CBT-MI combines elements from Cognitive Behavioural Therapy and Motivational Interviewing in treating nicotine addiction, delivered remotely via Zoom by trained 'layperson coaches'", 'armGroupLabels': ['CBT-MI']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LE67 2BF', 'city': 'Leicester', 'state': 'Midlands', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Helen Hayward, BSc', 'role': 'CONTACT', 'email': 'operations_manager@overcome.org.uk', 'phone': '447423967654'}], 'facility': 'Key contact', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}], 'centralContacts': [{'name': 'Helen Hayward, BSc', 'role': 'CONTACT', 'email': 'operations_manager@overcome.org.uk', 'phone': '447423967654'}], 'overallOfficials': [{'name': 'Helen Hayward, BSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Overcome'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'A member of the research team (HH) will regularly monitor the trial and its delivery to ensure ongoing study protocol compliance. In the event of deviations from the study protocol or unexpected events, the study team will promptly document and report such occurrences to the designated individuals and the Institutional Ethics review board, following the established reporting timelines. All study-related documentation, including data collection forms and interview transcripts, will be securely stored in password-protected electronic databases, adhering to data security and confidentiality guidelines.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Overcome', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}