Negotiating a Quit Date or Not in Online Interventions

Nicotine Dependence, Cigarettes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03194919
• Other study ID #: NFR 228158/H10-B
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2017
• Est. completion date: October 1, 2022

Study information

• Verified date: September 2021
• Source: University of Oslo
• Contact: Håvar Brendryen, PhD
• Phone: 99521714
• Email: brendryen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Nicotine Dependence, Cigarettes
• Tobacco Use Disorder

Intervention

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).

Locations

Country	Name	City	State
Czechia	Department of Addictology, 1st Faculty of Medicine, Charles University	Prague
Norway	The Norwegian Centre for Addiction Research	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
University of Oslo	Charles University, Czech Republic, The Research Council of Norway

Countries where clinical trial is conducted

Czechia,  Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quit attempt	User report a quit attempt	Within 6 weeks after starting the first session of the intervention
Secondary	Number of sessions in preparation phase completed	Ten sessions are available	Within 6 weeks after starting the first session of the intervention
Secondary	Number of sessions in preparation phase started	Ten sessions are available	Within 6 weeks after starting the first session of the intervention

External Links

•   Official home page for PI at host institution