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Negotiating a Quit Date or Not in Online Interventions

Primary Purpose

Nicotine Dependence, Cigarettes

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Endre: a digital smoking cessation counsellor
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nicotine Dependence, Cigarettes focused on measuring online intervention, e-Health, negotiating quit date

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

  • Department of Addictology, 1st Faculty of Medicine, Charles University
  • The Norwegian Centre for Addiction ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Negotiating quit date

Preset quit date

Arm Description

Endre: a digital smoking cessation counsellor

Endre: a digital smoking cessation counsellor

Outcomes

Primary Outcome Measures

Quit attempt
User report a quit attempt

Secondary Outcome Measures

Number of sessions in preparation phase completed
Ten sessions are available
Number of sessions in preparation phase started
Ten sessions are available

Full Information

First Posted
June 19, 2017
Last Updated
September 30, 2021
Sponsor
University of Oslo
Collaborators
The Research Council of Norway, Charles University, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT03194919
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 12, 2017 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
The Research Council of Norway, Charles University, Czech Republic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Cigarettes
Keywords
online intervention, e-Health, negotiating quit date

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Negotiating quit date
Arm Type
Experimental
Arm Description
Endre: a digital smoking cessation counsellor
Arm Title
Preset quit date
Arm Type
Active Comparator
Arm Description
Endre: a digital smoking cessation counsellor
Intervention Type
Other
Intervention Name(s)
Endre: a digital smoking cessation counsellor
Intervention Description
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 Measure Information:
Title
Quit attempt
Description
User report a quit attempt
Time Frame
Within 6 weeks after starting the first session of the intervention
Secondary Outcome Measure Information:
Title
Number of sessions in preparation phase completed
Description
Ten sessions are available
Time Frame
Within 6 weeks after starting the first session of the intervention
Title
Number of sessions in preparation phase started
Description
Ten sessions are available
Time Frame
Within 6 weeks after starting the first session of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Håvar Brendryen, PhD
Phone
99521714
Ext
+47
Email
brendryen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Håvar Brendryen, PhD
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Addictology, 1st Faculty of Medicine, Charles University
City
Prague
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roman Gabrhelík, PhD
Email
gabrhelik@adiktologie.cz
Facility Name
The Norwegian Centre for Addiction Research
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Håvar Brendryen, PhD
Phone
99521714
Ext
+47
Email
brendryen@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27354373
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.
Results Reference
background
Links:
URL
https://www.sv.uio.no/psi/english/people/aca/haavabre/index.html
Description
Official home page for PI at host institution

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Negotiating a Quit Date or Not in Online Interventions

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