Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-26 @ 12:49 AM
Study NCT ID:
NCT05991934
Status:
COMPLETED
Last Update Posted:
2025-05-20
First Post:
2023-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Testing the Impact of Smartphone-based Messaging to Support Young Adult Smoking Cessation - Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jthrul@jhu.edu', 'phone': '(443) 318-6633\u202c', 'title': 'Johannes Thrul, PhD', 'organization': 'Johns Hopkins Bloomberg School of Public Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 45 days', 'eventGroups': [{'id': 'EG000', 'title': 'Single Arm Pilot', 'description': "The micro-randomized trial will determine if CBT and Mindfulness/ACT messages are superior to control messages in reducing the primary outcome momentary smoking urges. Based on participants' training data collected in the initial 14 days of EMA monitoring, intervention messages will be delivered during time-periods and at high-risk locations for smoking. In the intervention phase, participants will be prompted to complete 3 geofence-triggered EMAs per day for a total of 30 days. Each EMA will be followed by an intervention message and the type of message (CBT, Mindfulness/ACT, control) will be randomly selected at each time point (within-subject randomization).", 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Smoking Urge as Assessed by Survey Item', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}, {'units': 'Message exposures', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Pilot', 'description': "The micro-randomized trial will determine if CBT and Mindfulness/ACT messages are superior to control messages in reducing the primary outcome momentary smoking urges. Based on participants' training data collected in the initial 14 days of EMA monitoring, intervention messages will be delivered during time-periods and at high-risk locations for smoking. In the intervention phase, participants will be prompted to complete 3 geofence-triggered EMAs per day for a total of 30 days. Each EMA will be followed by an intervention message and the type of message (CBT, Mindfulness/ACT, control) will be randomly selected at each time point (within-subject randomization)."}], 'classes': [{'title': 'Control: Pre-message EMA, smoking urge', 'categories': [{'measurements': [{'value': '2.59', 'spread': '1.30', 'groupId': 'OG000'}]}]}, {'title': 'Control: Follow-up EMA, smoking urge', 'categories': [{'measurements': [{'value': '2.39', 'spread': '1.27', 'groupId': 'OG000'}]}]}, {'title': 'CBT: Pre-message EMA, smoking urge', 'categories': [{'measurements': [{'value': '2.53', 'spread': '1.50', 'groupId': 'OG000'}]}]}, {'title': 'CBT: Follow-up EMA, smoking urge', 'categories': [{'measurements': [{'value': '2.16', 'spread': '1.35', 'groupId': 'OG000'}]}]}, {'title': 'ACT: Pre-message EMA, smoking urge', 'categories': [{'measurements': [{'value': '2.76', 'spread': '1.34', 'groupId': 'OG000'}]}]}, {'title': 'ACT: Follow-up EMA, smoking urge', 'categories': [{'measurements': [{'value': '2.40', 'spread': '1.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 15 minutes after message delivery', 'description': "The primary outcome is change in participants' rating of smoking urge from pre- to post-message surveys. Urge is assessed by a single item on a 5-point scale, ranging from 1 (very low) to 5 (very high) in pre and post surveys. Pre-message surveys are completed immediately before message delivery and post-message surveys are prompted 15 minutes after intervention message delivery. . Data presented here are Mean and Standard Deviation of smoking urge before (pre-message EMA) and after (follow-up EMA) a message was delivered for the different message conditions (Control, Cognitive behavioral therapy (CBT), Mindfulness or Acceptance and commitment Therapy (ACT)). Messages were randomized within subjects.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Message exposures', 'denomUnitsSelected': 'Message exposures', 'populationDescription': 'A total of 4 participants removed after the initial assessment phase who did not provide required data to construct geo-fences of high-risk situations for smoking that were required for the intervention phase and thus did not advance to the intervention phase and did not receive intervention messages.'}, {'type': 'PRIMARY', 'title': 'Change in Number of Cigarettes Smoked Per Day in Past Week as Assessed by a Single Item', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Pilot', 'description': "The micro-randomized trial will determine if CBT and Mindfulness/ACT messages are superior to control messages in reducing the primary outcome momentary smoking urges. Based on participants' training data collected in the initial 14 days of EMA monitoring, intervention messages will be delivered during time-periods and at high-risk locations for smoking. In the intervention phase, participants will be prompted to complete 3 geofence-triggered EMAs per day for a total of 30 days. Each EMA will be followed by an intervention message and the type of message (CBT, Mindfulness/ACT, control) will be randomly selected at each time point (within-subject randomization)."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.1', 'spread': '5.8', 'groupId': 'OG000'}]}]}, {'title': '45-day follow-up', 'categories': [{'measurements': [{'value': '3.2', 'spread': '2.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 45-day follow-up', 'description': 'The primary outcome will be change in self-reported number of cigarettes smoked per day in the past week from baseline to 45-days.', 'unitOfMeasure': 'Cigarettes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 4 participants removed after the initial assessment phase who did not provide required data to construct geo-fences of high-risk situations for smoking that were required for the intervention phase and thus did not advance to the intervention phase and did not receive intervention messages.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Arm Pilot', 'description': "The micro-randomized trial will determine if CBT and Mindfulness/ACT messages are superior to control messages in reducing the primary outcome momentary smoking urges. Based on participants' training data collected in the initial 14 days of EMA monitoring, intervention messages will be delivered during time-periods and at high-risk locations for smoking. In the intervention phase, participants will be prompted to complete 3 geofence-triggered EMAs per day for a total of 30 days. Each EMA will be followed by an intervention message and the type of message (CBT, Mindfulness/ACT, control) will be randomly selected at each time point (within-subject randomization)."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': "Participants were recruited through Facebook, Instagram, Reddit, and X advertisements that linked to a Qualtrics screening survey. All participants who met eligibility criteria had to provide online consent prior to study involvement. After consenting to participate but before being enrolled into the study, participants were required to send study staff a picture of a valid identification (e.g., driver's license) that had their name, picture, and birthdate to validate their age and identity."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm Pilot', 'description': "The micro-randomized trial will determine if CBT and Mindfulness/ACT messages are superior to control messages in reducing the primary outcome momentary smoking urges. Based on participants' training data collected in the initial 14 days of EMA monitoring, intervention messages will be delivered during time-periods and at high-risk locations for smoking. In the intervention phase, participants will be prompted to complete 3 geofence-triggered EMAs per day for a total of 30 days. Each EMA will be followed by an intervention message and the type of message (CBT, Mindfulness/ACT, control) will be randomly selected at each time point (within-subject randomization)."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.3', 'spread': '3.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-03-19', 'size': 618551, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-02T08:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A pilot micro-randomized trial (within-subject randomization) with 10 young adult smokers will investigate the feasibility of delivering smoking cessation messages based on CBT and mindfulness/ACT for reducing smoking urge 15 minutes after message delivery.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-02', 'studyFirstSubmitDate': '2023-08-07', 'resultsFirstSubmitDate': '2025-05-02', 'studyFirstSubmitQcDate': '2023-08-07', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-02', 'studyFirstPostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking Urge as Assessed by Survey Item', 'timeFrame': 'Baseline, 15 minutes after message delivery', 'description': "The primary outcome is change in participants' rating of smoking urge from pre- to post-message surveys. Urge is assessed by a single item on a 5-point scale, ranging from 1 (very low) to 5 (very high) in pre and post surveys. Pre-message surveys are completed immediately before message delivery and post-message surveys are prompted 15 minutes after intervention message delivery. . Data presented here are Mean and Standard Deviation of smoking urge before (pre-message EMA) and after (follow-up EMA) a message was delivered for the different message conditions (Control, Cognitive behavioral therapy (CBT), Mindfulness or Acceptance and commitment Therapy (ACT)). Messages were randomized within subjects."}, {'measure': 'Change in Number of Cigarettes Smoked Per Day in Past Week as Assessed by a Single Item', 'timeFrame': 'Baseline, 45-day follow-up', 'description': 'The primary outcome will be change in self-reported number of cigarettes smoked per day in the past week from baseline to 45-days.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco Cigarette Smoking']}, 'referencesModule': {'references': [{'pmid': '41211017', 'type': 'DERIVED', 'citation': 'Thrul J, Devkota J, Hamoud J, Waring JJC, Luken A, Han JJ, Naughton F, Zipunnikov V, Mendelson T, Latkin C, Moran M, Epstein D, Desjardins MR. Micro-randomized pilot trial of an app-based smoking urge reduction intervention for young adults. Mhealth. 2025 Oct 29;11:59. doi: 10.21037/mhealth-25-17. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'Clinical practice guidelines for smoking cessation emphasize cognitive behavioral therapy (CBT) to help patients develop coping strategies for urges. Mindfulness or Acceptance and commitment Therapy (ACT) offer a different approach, which teaches smokers psychological flexibility through accepting negative experiences. While there is evidence for the efficacy of both CBT and Mindfulness/ACT smoking cessation interventions, it is unclear if these approaches are efficacious when implemented in real-time and with young adults. The overall goal of this proposal is to evaluate the efficacy of CBT and Mindfulness/ACT messages for young adults targeted at specific high-risk situations for smoking.', 'detailedDescription': "To conduct a pilot trial to test CBT and Mindfulness/ACT intervention message efficacy for reducing momentary smoking urges (N=10). To inform just-in-time interventions, it is crucial to test if CBT and Mindfulness/ACT based messages can reduce momentary smoking urges. The investigators will conduct a micro-randomized trial (repeated within-subject randomizations of messages) to accomplish this. In line with the investigators' existing protocol, participants first collect Ecological Momentary Assessment (EMA) data for 14 days, allowing the investigators to determine high-risk situations for smoking. In the following intervention phase, participants receive tailored messages triggered by geofencing of participants' high-risk locations for a total of 30 days. Tailoring is based on established predictors of smoking relapse (stress and presence of other smokers). The micro-randomized trial tests the efficacy of CBT versus Mindfulness/ACT versus control messages for reducing smoking urge 15 minutes post message delivery. Secondary outcomes include smoking or other tobacco use (including e-cigarettes), affect, and stress. After 45 days, follow up interviews with participants will be conducted to collect information on their study experience."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. live in the U.S.\n2. read English;\n3. are between 18 and 30 years of age;\n4. own an iPhone or Android smartphone;\n5. have smoked ≥100 cigarettes and currently smoke at least 1 cigarette per day on 3 or more days of the week;\n6. are planning to quit smoking within the next 30 days.\n\nExclusion Criteria:\n\n* live internationally\n* don't read English\n* younger than 18, older than 30\n* don't own a iPhone or Android smartphone\n* have smoked less than 100 cigarettes\n* not planning to quit smoking in the next 30 days"}, 'identificationModule': {'nctId': 'NCT05991934', 'briefTitle': 'Testing the Impact of Smartphone-based Messaging to Support Young Adult Smoking Cessation - Pilot', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'Testing the Impact of Smartphone-based Messaging to Support Young Adult Smoking Cessation', 'orgStudyIdInfo': {'id': 'IRB00013413-Pilot'}, 'secondaryIdInfos': [{'id': 'IRB00013413', 'type': 'OTHER', 'domain': 'JHSPH IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm pilot', 'description': "The micro-randomized trial will determine if CBT and Mindfulness/ACT messages are superior to control messages in reducing the primary outcome momentary smoking urges. Based on participants' training data collected in the initial 14 days of EMA monitoring, intervention messages will be delivered during time-periods and at high-risk locations for smoking. In the intervention phase, participants will be prompted to complete 3 geofence-triggered EMAs per day for a total of 30 days. Each EMA will be followed by an intervention message and the type of message (CBT, Mindfulness/ACT, control) will be randomly selected at each time point (within-subject randomization).", 'interventionNames': ['Behavioral: Smartphone-based intervention messages']}], 'interventions': [{'name': 'Smartphone-based intervention messages', 'type': 'BEHAVIORAL', 'description': 'Intervention messages in the proposed trial will address specific high-risk situations for smoking and smoking urges. Messages will focus on two key situational triggers for message matching: 1. Stress (high/low) and 2. Presence of other smokers (yes/no). For each situation, characterized by a combination of these characteristics, several messages were developed. To improve user engagement with the intervention, all messages contain visual content in form of pictures.', 'armGroupLabels': ['Single arm pilot']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Bloomberg School of Public Health', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Johannes Thrul, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins Bloomberg School of Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Any individual requests for data will be honored on a case-by-case basis as deemed appropriate to the research protocol.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}