Negotiating a Quit Date or Not in Online Interventions

Overview

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.

Full Title of Study: “The Effect of Negotiating a Quit Date on Attempting to Quit Smoking”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2021

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.

Interventions

  • 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).

Arms, Groups and Cohorts

  • Experimental: Negotiating quit date
    • Endre: a digital smoking cessation counsellor
  • Active Comparator: Preset quit date
    • Endre: a digital smoking cessation counsellor

Clinical Trial Outcome Measures

Primary Measures

  • Quit attempt
    • Time Frame: Within 6 weeks after starting the first session of the intervention
    • User report a quit attempt

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Oslo
  • Collaborator
    • The Research Council of Norway
  • Provider of Information About this Clinical Study
    • Principal Investigator: Håvar Brendryen, Senior Research Scientist – University of Oslo
  • Overall Official(s)
    • Håvar Brendryen, PhD, Principal Investigator, University of Oslo
  • Overall Contact(s)
    • Håvar Brendryen, PhD, 99521714, brendryen@gmail.com

References

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.