Online Lapse Management Intervention

September 30, 2021 updated by: Håvar Brendryen, University of Oslo

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
      • Praha, Czechia
        • Not yet recruiting
        • Department of Addictology, 1st Faculty of Medicine, Charles University
        • Contact:
  • Norway
      • Oslo, Norway
        • Recruiting
        • The Norwegian Centre for Addiction Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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")

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard web-application
Endre: a digital smoking cessation counsellor
Other: Endre: a digital smoking cessation counsellor
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).
Experimental: Web-based lapse management system
Endre: a digital smoking cessation counsellor + Lapse management system triggered from web-page
Other: Endre: a digital smoking cessation counsellor
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).
Other: Lapse management system triggered from web-page
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.
Experimental: SMS & web-based lapse management system
Endre: a digital smoking cessation counsellor + Lapse management system triggered by SMS-textmessage
Other: Endre: a digital smoking cessation counsellor
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).
Other: Lapse management system triggered by SMS-textmessage
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7 day point prevalence abstinence from cigarettes
Time Frame: measured at six months post cessation
no tobacco smoking during the last seven days
measured at six months post cessation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7 day point prevalence abstinence from cigarettes
Time Frame: measured at one month post cessation
no tobacco smoking during the last seven days
measured at one month post cessation
7 day point prevalence abstinence from any nicotine products
Time Frame: measured at one month post cessation
no use of products containing nicotine (smoking tobacco, snuff, e-cigarettes, nicotine replacement products etc) during the last seven days
measured at one month post cessation
7 day point prevalence abstinence from any nicotine products
Time Frame: measured at six months post cessation
no use of products containing nicotine (smoking tobacco, snuff, e-cigarettes, nicotine replacement products etc) during the last seven days
measured at six months post cessation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
user engagement
Time Frame: during a one month timeframe after initial quit attempt
number of completed sessions after initial quit attempt
during a one month timeframe after initial quit attempt
number of lapse episodes after initial quit attempt
Time Frame: assessed one month after cessation day
lapse episode = experiencing a temporary setback, i.e., smoking one or several cigarettes and then beeing abstinent again
assessed one month after cessation day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Collaborators

Charles University, Czech Republic
The Research Council of Norway

Investigators

  • Principal Investigator: Håvar Brendryen, PhD, University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2017

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

June 14, 2017

First Submitted That Met QC Criteria

June 16, 2017

First Posted (Actual)

June 19, 2017

Study Record Updates

Last Update Posted (Actual)

October 8, 2021

Last Update Submitted That Met QC Criteria

September 30, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFR 228158/H10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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