Negotiating a Quit Date or Not in Online Interventions

Study Overview
=================
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.

Official Title
-----------------
The Effect of Negotiating a Quit Date on Attempting to Quit Smoking

Conditions
-----------------
Nicotine Dependence, Cigarettes

Intervention / Treatment
-----------------
* Other: Endre: a digital smoking cessation counsellor


Participation Criteria
=================
Eligibility Criteria
-----------------
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: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Negotiating quit date<br>Endre: a digital smoking cessation counsellor | Other: Endre: a digital smoking cessation counsellor<br>* 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).<br>|
| Active Comparator: Preset quit date<br>Endre: a digital smoking cessation counsellor | Other: Endre: a digital smoking cessation counsellor<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quit attempt | User report a quit attempt | Within 6 weeks after starting the first session of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of sessions in preparation phase completed | Ten sessions are available | Within 6 weeks after starting the first session of the intervention | 
| Number of sessions in preparation phase started | Ten sessions are available | Within 6 weeks after starting the first session of the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
e-Health, online intervention, negotiating quit date