Nicotine Dependence, CigarettesNCT03194919
Negotiating a Quit Date or Not in Online Interventions
A study testing Endre: a digital smoking cessation counsellor in people with Nicotine Dependence, Cigarettes, run by University of Oslo at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Cigarettes
- What is being tested?
- Endre: a digital smoking cessation counsellor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Sep 2017to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Czechia1 site, 1 recruiting
- Not yet recruiting
Department of Addictology, 1st Faculty of Medicine, Charles University
Prague
Roman Gabrhelík, PhD, gabrhelik@adiktologie.cz
Norway1 site, 1 recruiting
- Recruiting
The Norwegian Centre for Addiction Research
Oslo
Håvar Brendryen, PhD, 99521714 ext. +47, brendryen@gmail.com
About this study
Official title: The Effect of Negotiating a Quit Date on Attempting to Quit Smoking
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.
Read the 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.
- Conditions
- Nicotine Dependence, Cigarettes
- Being tested
- Endre: a digital smoking cessation counsellor
- Keywords
- online intervention, e-Health, negotiating quit date
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endre: a digital smoking cessation counsellorOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Negotiating quit date | Experimental | Endre: a digital smoking cessation counsellor Receives: Other: Endre: a digital smoking cessation counsellor |
| Preset quit date | Active comparator | Endre: a digital smoking cessation counsellor Receives: Other: Endre: a digital smoking cessation counsellor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quit attempt
User report a quit attempt
Measured: Within 6 weeks after starting the first session of the intervention
Secondary outcomes (2)
Number of sessions in preparation phase completed
Ten sessions are available
Measured: Within 6 weeks after starting the first session of the intervention
Number of sessions in preparation phase started
Ten sessions are available
Measured: Within 6 weeks after starting the first session of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start12 Sep 2017
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine Dependence, CigarettesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, Charles University, Czech Republic
- Responsible party
- Principal investigator, Håvar Brendryen, University of Oslo
- Investigators
- Håvar Brendryen, PhD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194919
- Sponsor's protocol ID
- NFR 228158/H10-B
- Status last verified
- Sep 2021
- First submitted
- 19 Jun 2017
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27354373
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Negotiating a Quit Date on Attempting to Quit Smoking
- ClinicalTrials.gov ID
- NCT03194919
- Acronym / sponsor ID
- NFR 228158/H10-B
- Conditions
- Nicotine Dependence, Cigarettes
- Keywords
- online intervention, e-Health, negotiating quit date
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- The Research Council of Norway, Charles University, Czech Republic
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Negotiating quit date | Experimental | Other: Endre: a digital smoking cessation counsellorEndre: a digital smoking cessation counsellor |
| Preset quit date | Active comparator | Other: Endre: a digital smoking cessation counsellorEndre: a digital smoking cessation counsellor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endre: a digital smoking cessation counsellorA 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). | Other | Negotiating quit date, Preset quit date |
Primary outcome
Quit attempt
Time frame: Within 6 weeks after starting the first session of the intervention
User report a quit attempt
2 secondary outcomes
Number of sessions in preparation phase completed
Time frame: Within 6 weeks after starting the first session of the intervention
Number of sessions in preparation phase started
Time frame: Within 6 weeks after starting the first session of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Background: PubMed 27354373Holter 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.
- Official home page for PI at host institutionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Håvar Brendryen, PhD principal investigator
University of Oslo
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endre: a digital smoking cessation counsellor in people with Nicotine Dependence, Cigarettes, run by University of Oslo at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Håvar Brendryen, PhD (99521714 ext. +47, brendryen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quit attempt (time frame: Within 6 weeks after starting the first session of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03194919, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.