Clinical trial NCT03194919: Negotiating a Quit Date or Not in Online Interventions
Official title: The Effect of Negotiating a Quit Date on Attempting to Quit Smoking
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nicotine Dependence, Cigarettes
Keywords: online intervention
e-Health
negotiating quit date
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: Charles University, Czech Republic
First posted: 2017-06-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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:

-

Primary outcomes:
measure: Quit attempt
timeFrame: Within 6 weeks after starting the first session of the intervention
Secondary outcomes:
measure: Number of sessions in preparation phase completed
timeFrame: Within 6 weeks after starting the first session of the intervention
measure: Number of sessions in preparation phase started
timeFrame: Within 6 weeks after starting the first session of the intervention
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Department of Addictology, 1st Faculty of Medicine, Charles University
city: Oslo
country: Norway
facility: The Norwegian Centre for Addiction Research
Study officials:
affiliation: University of Oslo
name: Håvar Brendryen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.