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Negotiating a Quit Date or Not in Online Interventions

The Effect of Negotiating a Quit Date on Attempting to Quit Smoking

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03194919
Enrollment
1500
Registered
2017-06-21
Start date
2017-09-12
Completion date
2022-10-01
Last updated
2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine Dependence, Cigarettes

Keywords

online intervention, e-Health, negotiating quit date

Brief summary

The primary purpose of the current study is to test the effect of providing users of automated web-based smoking cessation interventions with the option of negotiating and re-negotiating the quit date.

Detailed description

Web- and mobile phone health behavior change interventions, including smoking cessation programs, offer great promise, but little is known about how such interventions should be designed to increase their efficacy The primary purpose of the current study is to test the effect of providing users of automated web-based smoking cessation interventions with the option of negotiating and re-negotiating the quit date. The investigators propose a 2-arm RCT with 1500 adult study participants that all receive a best practices web-based smoking cessation program designed for use on smart phones (web-app). The intervention includes a ten day/session preparation phase (participants continue smoking) as well as a four week post-cessation follow-up phase (14 sessions). The post-cessation phase will only be given to participants that report an initial quit attempt. Participants will be randomized to two versions of the intervention: 1) A version that does not provide participants with the option of negotiating the quit day (the preparation phase is fixed to ten days/sessions); or 2) a version that provides the participants with the option of negotiating/re-negotiate the quit day on three occasions. The three occasions are on the first day/session of the intervention, on the fourth day/session of the intervention and on the eleventh day/session of the intervention. The primary outcome is making a quit attempt.

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).

Sponsors

The Research Council of Norway
CollaboratorOTHER
Charles University, Czech Republic
CollaboratorOTHER
University of Oslo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

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.

Intervention model description

Participants receive one out of two versions of a web-based smoking cessation program. Either with or without the option of negotiating and re-negotiating the quit date.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 18 year or older * being 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 * start using the intervention (pushing the next page button one time or more on the first session provided

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Quit attemptWithin 6 weeks after starting the first session of the interventionUser report a quit attempt

Secondary

MeasureTime frameDescription
Number of sessions in preparation phase completedWithin 6 weeks after starting the first session of the interventionTen sessions are available
Number of sessions in preparation phase startedWithin 6 weeks after starting the first session of the interventionTen sessions are available

Countries

Czechia, Norway

Contacts

Primary ContactHåvar Brendryen, PhD
brendryen@gmail.com99521714

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026