Nicotine Dependence, CigarettesNCT03191825
Online Lapse Management Intervention
A study testing Endre: a digital smoking cessation counsellor, Lapse management system triggered from web-page and Lapse management system triggered by SMS-textmessage in people with Nicotine Dependence, Cigarettes, run by University of Oslo at 2 sites in 2 countries.
Trial summary
The purpose of the trial is to test the adjunctive effect of adding a lapse management system to a best practices web- and mobile smoking cessation program. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Cigarettes
- What is being tested?
- Endre: a digital smoking cessation counsellor, Lapse management system triggered from web-page and Lapse management system triggered by SMS-textmessage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Sep 2017to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 year or older
- beeing a current smoker
- determined to or considering to quit smoking
- provide valid e-mail address
- provide valid norwegian cell phone number
- complete a baseline questionnaire
- complete a ten day run-in period (preparation phase)
- reporting an initial quit attempt ("yes, today I have quit smoking")
Who cannot join
- -
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Czechia1 site, 1 recruiting
- Not yet recruiting
Department of Addictology, 1st Faculty of Medicine, Charles University
Prague
Roman Gabrhelík, PhD, gabrhelik@adiktologie.cz
Norway1 site, 1 recruiting
- Recruiting
The Norwegian Centre for Addiction Research
Oslo
Håvar Brendryen, PhD, 99521714 ext. +47, brendryen@gmail.com
About this study
Official title: Testing the Efficacy of a Lapse Management System in an Online Smoking Cessation
The purpose of the trial is to test the adjunctive effect of adding a lapse management system to a best practices web- and mobile smoking cessation program.
Read the detailed description
Background: Web- and mobile phone health behavior change interventions, including smoking cessation programs, offer great promise, but little is known about the components that may add to their effect.
Objectives: To assess tobacco abstinence associated with an adjunctive lapse management system combined with a best-practices web- and mobilephone based smoking cessation intervention. The investigators hypothesize that a program that includes the lapse management system will yield greater efficacy than a program that does not include such a component.
Methods: The investigators propose a 3-arm RCT with 1500 adult study participants that all receive a best practices web-based smoking cessation program designed for use on snart phones (web-app). Participants are randomized to either the web-app only, the web-app plus a web-based lapse management system, or web-app plus a SMS-based lapse management system.
The lapse management system will be based on the day-to-day logging of target behavior and providing just-in-time therapy to clients reporting a lapse. In the two versions of the lapse management system the logging of target behavior is done by asking a question about smoking status by web or SMS.
Measures: The primary outcome is 7-day point prevalence tobacco abstinence (as assessed at the 1- and 6-months follow-up). Potential predictors, moderators, and mediators of abstinence will also be examined.
Benefits: This protocol describes the first RCT that assesses the incremental efficacy of adding a lapse management system to an online smoking cessation intervention. These interventions constitute a cost-effective means to reach smokers who want to quit. By seeking to identify beneficial adjunctive mechanisms, their efficacy may be improved, which can make a substantial public health impact.
- Conditions
- Nicotine Dependence, Cigarettes
- Being tested
- Endre: a digital smoking cessation counsellor, Lapse management system triggered from web-page, Lapse management system triggered by SMS-textmessage
- Keywords
- online intervention, mHealth m-Health, eHealth e-Health, smoking cessation, lapse management, relapse prevention
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endre: a digital smoking cessation counsellorOther
A comprehensive 25-session intervention delivered by web, e-mail and SMS-text messages. Sessions are released one each day for 18 days, and then every second day for 14 days. Intervention content is tailored based on user input and individual usage pattern. The intervention is described in detail in Holter, Johansen \& Brendryen (2016). How a fully automated eHealth program simulates three therapeutic processes: A case study. Journal of Medical Internet Research 18 (6).
Lapse management system triggered from web-pageOther
The lapse management system is based on a day-to-day logging of the target behavior (smoking). This logging goes on for four weeks after an initial quit attempt. The current version of the system logs by asking the participant about their smoking status every time they log on to "Endre" (the digital smoking cessation counsellor). Participants that report a lapse is routed to a fully automated counselling session delivered by web.
Lapse management system triggered by SMS-textmessageOther
The lapse management system is based on a day-to-day logging of the target behavior (smoking). This logging goes on for four weeks after an initial quit attempt. The current version of the system logs by asking the participant about their smoking status in a textmessage (SMS) sent each evening. Participants that report a lapse, receives a new SMS with a link to a fully automated counselling session delivered by web.
| Study group | Role | What they receive |
|---|---|---|
| Standard web-application | Active comparator | Endre: a digital smoking cessation counsellor Receives: Other: Endre: a digital smoking cessation counsellor |
| Web-based lapse management system | Experimental | Endre: a digital smoking cessation counsellor + Lapse management system triggered from web-page Receives: Other: Endre: a digital smoking cessation counsellor; Other: Lapse management system triggered from web-page |
| SMS & web-based lapse management system | Experimental | Endre: a digital smoking cessation counsellor + Lapse management system triggered by SMS-textmessage Receives: Other: Endre: a digital smoking cessation counsellor; Other: Lapse management system triggered by SMS-textmessage |
What is being measured
The primary outcome is the main question the study is designed to answer.
7 day point prevalence abstinence from cigarettes
no tobacco smoking during the last seven days
Measured: measured at six months post cessation
Secondary outcomes (3)
7 day point prevalence abstinence from cigarettes
no tobacco smoking during the last seven days
Measured: measured at one month post cessation
7 day point prevalence abstinence from any nicotine products
no use of products containing nicotine (smoking tobacco, snuff, e-cigarettes, nicotine replacement products etc) during the last seven days
Measured: measured at one month post cessation
7 day point prevalence abstinence from any nicotine products
no use of products containing nicotine (smoking tobacco, snuff, e-cigarettes, nicotine replacement products etc) during the last seven days
Measured: measured at six months post cessation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start12 Sep 2017
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine Dependence, CigarettesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants receive one out of three versions of a web-based smoking cessation program. Two of the versions includes a lapse management system that are based on a day-to-day logging of target behavior. In one version the logging is done on the web, while on the other version, logging is done by SMS-textmessages.
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, Charles University, Czech Republic
- Responsible party
- Principal investigator, Håvar Brendryen, University of Oslo
- Investigators
- Håvar Brendryen, PhD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191825
- Sponsor's protocol ID
- NFR 228158/H10
- Status last verified
- Sep 2021
- First submitted
- 14 Jun 2017
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holter MT, Johansen A, Brendryen H. How a Fully Automated eHealth Program Simulates Three Therapeutic Processes: A Case Study. J Med Internet Res. 2016 Jun 28;18(6):e176. doi: 10.2196/jmir.5415.
PubMed 27354373
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of a Lapse Management System in an Online Smoking Cessation
- ClinicalTrials.gov ID
- NCT03191825
- Acronym / sponsor ID
- NFR 228158/H10
- Conditions
- Nicotine Dependence, Cigarettes
- Keywords
- online intervention, mHealth m-Health, eHealth e-Health, smoking cessation, lapse management, relapse prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- The Research Council of Norway, Charles University, Czech Republic
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the trial is to test the adjunctive effect of adding a lapse management system to a best practices web- and mobile smoking cessation program.
Detailed description
Background: Web- and mobile phone health behavior change interventions, including smoking cessation programs, offer great promise, but little is known about the components that may add to their effect.
Objectives: To assess tobacco abstinence associated with an adjunctive lapse management system combined with a best-practices web- and mobilephone based smoking cessation intervention. The investigators hypothesize that a program that includes the lapse management system will yield greater efficacy than a program that does not include such a component.
Methods: The investigators propose a 3-arm RCT with 1500 adult study participants that all receive a best practices web-based smoking cessation program designed for use on snart phones (web-app). Participants are randomized to either the web-app only, the web-app plus a web-based lapse management system, or web-app plus a SMS-based lapse management system.
The lapse management system will be based on the day-to-day logging of target behavior and providing just-in-time therapy to clients reporting a lapse. In the two versions of the lapse management system the logging of target behavior is done by asking a question about smoking status by web or SMS.
Measures: The primary outcome is 7-day point prevalence tobacco abstinence (as assessed at the 1- and 6-months follow-up). Potential predictors, moderators, and mediators of abstinence will also be examined.
Benefits: This protocol describes the first RCT that assesses the incremental efficacy of adding a lapse management system to an online smoking cessation intervention. These interventions constitute a cost-effective means to reach smokers who want to quit. By seeking to identify beneficial adjunctive mechanisms, their efficacy may be improved, which can make a substantial public health impact.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All participants receive one out of three versions of a web-based smoking cessation program. Two of the versions includes a lapse management system that are based on a day-to-day logging of target behavior. In one version the logging is done on the web, while on the other version, logging is done by SMS-textmessages.
| Arm | Type | Receives |
|---|---|---|
| Standard web-application | Active comparator | Other: Endre: a digital smoking cessation counsellorEndre: a digital smoking cessation counsellor |
| Web-based lapse management system | Experimental | Other: Endre: a digital smoking cessation counsellor, Other: Lapse management system triggered from web-pageEndre: a digital smoking cessation counsellor + Lapse management system triggered from web-page |
| SMS & web-based lapse management system | Experimental | Other: Endre: a digital smoking cessation counsellor, Other: Lapse management system triggered by SMS-textmessageEndre: a digital smoking cessation counsellor + Lapse management system triggered by SMS-textmessage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 year or older
- beeing a current smoker
- determined to or considering to quit smoking
- provide valid e-mail address
- provide valid norwegian cell phone number
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endre: a digital smoking cessation counsellorA comprehensive 25-session intervention delivered by web, e-mail and SMS-text messages. Sessions are released one each day for 18 days, and then every second day for 14 days. Intervention content is tailored based on user input and individual usage pattern. The intervention is described in detail in Holter, Johansen \& Brendryen (2016). How a fully automated eHealth program simulates three therapeutic processes: A case study. Journal of Medical Internet Research 18 (6). | Other | SMS & web-based lapse management system, Standard web-application, Web-based lapse management system |
| Lapse management system triggered from web-pageThe lapse management system is based on a day-to-day logging of the target behavior (smoking). This logging goes on for four weeks after an initial quit attempt. The current version of the system logs by asking the participant about their smoking status every time they log on to "Endre" (the digital smoking cessation counsellor). Participants that report a lapse is routed to a fully automated counselling session delivered by web. | Other | Web-based lapse management system |
| Lapse management system triggered by SMS-textmessageThe lapse management system is based on a day-to-day logging of the target behavior (smoking). This logging goes on for four weeks after an initial quit attempt. The current version of the system logs by asking the participant about their smoking status in a textmessage (SMS) sent each evening. Participants that report a lapse, receives a new SMS with a link to a fully automated counselling session delivered by web. | Other | SMS & web-based lapse management system |
Primary outcome
7 day point prevalence abstinence from cigarettes
Time frame: measured at six months post cessation
no tobacco smoking during the last seven days
3 secondary outcomes
7 day point prevalence abstinence from cigarettes
Time frame: measured at one month post cessation
7 day point prevalence abstinence from any nicotine products
Time frame: measured at one month post cessation
7 day point prevalence abstinence from any nicotine products
Time frame: measured at six months post cessation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Background: PubMed 27354373Holter MT, Johansen A, Brendryen H. How a Fully Automated eHealth Program Simulates Three Therapeutic Processes: A Case Study. J Med Internet Res. 2016 Jun 28;18(6):e176. doi: 10.2196/jmir.5415.
- Official home page for PI at host institutionLink provided by the sponsor.
- PIs Google Schoolar ProfileLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Håvar Brendryen, PhD principal investigator
University of Oslo
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endre: a digital smoking cessation counsellor, Lapse management system triggered from web-page and Lapse management system triggered by SMS-textmessage in people with Nicotine Dependence, Cigarettes, run by University of Oslo at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Håvar Brendryen, PhD (+47 99 52 17 14, brendryen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7 day point prevalence abstinence from cigarettes (time frame: measured at six months post cessation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03191825, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.