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Negotiating a Quit Date or Not in Online Interventions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03194919
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : May 14, 2018
Sponsor:
Collaborators:
The Research Council of Norway
Charles University, Czech Republic
Information provided by (Responsible Party):
Håvar Brendryen, University of Oslo

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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence, Cigarettes Other: Endre: a digital smoking cessation counsellor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Masking Description:

The recruitment procedure and the treatment is fully automated and delivered by web, e-mail and SMS-textmessages - i.e., the participant is not contacted by any care providers, investigators or assessors during recruitment or treatment

- and data are collected by means of web-based questionnaires.

Primary Purpose: Prevention
Official Title: The Effect of Negotiating a Quit Date on Attempting to Quit Smoking
Actual Study Start Date : September 12, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Negotiating quit date
Endre: a digital smoking cessation counsellor
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).

Active Comparator: Preset quit date
Endre: a digital smoking cessation counsellor
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).




Primary Outcome Measures :
  1. Quit attempt [ Time Frame: Within 6 weeks after starting the first session of the intervention ]
    User report a quit attempt


Secondary Outcome Measures :
  1. Number of sessions in preparation phase completed [ Time Frame: Within 6 weeks after starting the first session of the intervention ]
    Ten sessions are available

  2. Number of sessions in preparation phase started [ Time Frame: Within 6 weeks after starting the first session of the intervention ]
    Ten sessions are available



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194919


Contacts
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Contact: Håvar Brendryen, PhD 99521714 ext +47 brendryen@gmail.com

Locations
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Czechia
Department of Addictology, 1st Faculty of Medicine, Charles University Not yet recruiting
Prague, Czechia
Contact: Roman Gabrhelík, PhD       gabrhelik@adiktologie.cz   
Norway
The Norwegian Centre for Addiction Research Recruiting
Oslo, Norway
Contact: Håvar Brendryen, PhD    99521714 ext +47    brendryen@gmail.com   
Sponsors and Collaborators
University of Oslo
The Research Council of Norway
Charles University, Czech Republic
Investigators
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Principal Investigator: Håvar Brendryen, PhD University of Oslo

Additional Information:
Publications:
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Responsible Party: Håvar Brendryen, Senior Research Scientist, University of Oslo
ClinicalTrials.gov Identifier: NCT03194919    
Other Study ID Numbers: NFR 228158/H10-B
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Håvar Brendryen, University of Oslo:
online intervention
e-Health
negotiating quit date
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders