Online Lapse Management Intervention
Testing the Efficacy of a Lapse Management System in an Online Smoking Cessation
1 other identifier
interventional
1,500
2 countries
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2017
CompletedFirst Posted
Study publicly available on registry
June 19, 2017
CompletedStudy Start
First participant enrolled
September 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedOctober 8, 2021
September 1, 2021
5.1 years
June 14, 2017
September 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
7 day point prevalence abstinence from cigarettes
no tobacco smoking during the last seven days
measured at six months post cessation
Secondary Outcomes (3)
7 day point prevalence abstinence from cigarettes
measured at one month post cessation
7 day point prevalence abstinence from any nicotine products
measured at one month post cessation
7 day point prevalence abstinence from any nicotine products
measured at six months post cessation
Other Outcomes (2)
user engagement
during a one month timeframe after initial quit attempt
number of lapse episodes after initial quit attempt
assessed one month after cessation day
Study Arms (3)
Standard web-application
ACTIVE COMPARATOREndre: a digital smoking cessation counsellor
Web-based lapse management system
EXPERIMENTALEndre: a digital smoking cessation counsellor + Lapse management system triggered from web-page
SMS & web-based lapse management system
EXPERIMENTALEndre: a digital smoking cessation counsellor + Lapse management system triggered by SMS-textmessage
Interventions
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).
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.
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.
Eligibility Criteria
You may qualify if:
- 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")
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oslolead
- The Research Council of Norwaycollaborator
- Charles University, Czech Republiccollaborator
Study Sites (2)
Department of Addictology, 1st Faculty of Medicine, Charles University
Prague, Czechia
The Norwegian Centre for Addiction Research
Oslo, Norway
Related Publications (1)
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.
PMID: 27354373BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Håvar Brendryen, PhD
University of Oslo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- The recruitment procedure and the treatment is fully automated and delivered by web, e-mail and SMS-textmessages - i.e., the participant is not contacted by any care providers, investigators or assessors during recruitment or treatment - and data are collected by means of web-based questionnaires. However, non-responders to the questionnaires will be contacted by phone for telephone interview.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior researcher
Study Record Dates
First Submitted
June 14, 2017
First Posted
June 19, 2017
Study Start
September 12, 2017
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
October 8, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share