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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03194919
Other study ID # NFR 228158/H10-B
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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: -

Study Design


Related Conditions & MeSH terms


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
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