Negotiating a Quit Date or Not in Online Interventions

Not Applicable

• Conditions: Nicotine Dependence, Cigarettes

• Registration Number: NCT03194919
• Lead Sponsor: University of Oslo

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.

Study Timeline

• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-21
• Study Start: 2017-09-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-30
• Last Update Posted: 2021-10-08
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quit attempt	Within 6 weeks after starting the first session of the intervention	User report a quit attempt

Secondary Outcome Measures

Name	Time	Method
Number of sessions in preparation phase completed	Within 6 weeks after starting the first session of the intervention	Ten sessions are available
Number of sessions in preparation phase started	Within 6 weeks after starting the first session of the intervention	Ten sessions are available

Trial Locations

Locations (2)

The Norwegian Centre for Addiction Research; 🇳🇴 Oslo, Norway

Department of Addictology, 1st Faculty of Medicine, Charles University; 🇨🇿 Prague, Czechia