Negotiating a Quit Date or Not in Online Interventions

NCT ID: NCT03194919

Last Updated: 2021-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-12

Study Completion Date

2022-10-01

Brief Summary

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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

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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

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Nicotine Dependence, Cigarettes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

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.

Study Groups

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Negotiating quit date

Endre: a digital smoking cessation counsellor

Group Type EXPERIMENTAL

Endre: a digital smoking cessation counsellor

Intervention Type OTHER

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).

Preset quit date

Endre: a digital smoking cessation counsellor

Group Type ACTIVE_COMPARATOR

Endre: a digital smoking cessation counsellor

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Research Council of Norway

OTHER

Sponsor Role collaborator

Charles University, Czech Republic

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role lead

Responsible Party

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Håvar Brendryen

Senior Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Håvar Brendryen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Locations

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Department of Addictology, 1st Faculty of Medicine, Charles University

Prague, , Czechia

Site Status NOT_YET_RECRUITING

The Norwegian Centre for Addiction Research

Oslo, , Norway

Site Status RECRUITING

Countries

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Czechia Norway

Central Contacts

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Håvar Brendryen, PhD

Role: CONTACT

99521714 ext. +47

Facility Contacts

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Roman Gabrhelík, PhD

Role: primary

Håvar Brendryen, PhD

Role: primary

99521714 ext. +47

References

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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.

Reference Type BACKGROUND
PMID: 27354373 (View on PubMed)

Related Links

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https://www.sv.uio.no/psi/english/people/aca/haavabre/index.html

Official home page for PI at host institution

Other Identifiers

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NFR 228158/H10-B

Identifier Type: -

Identifier Source: org_study_id

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