NCT03194919

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 12, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

October 8, 2021

Status Verified

September 1, 2021

Enrollment Period

5.1 years

First QC Date

June 19, 2017

Last Update Submit

September 30, 2021

Conditions

Nicotine Dependence, Cigarettes

Keywords

online interventione-Healthnegotiating quit date

Outcome Measures

Primary Outcomes (1)

  • Quit attempt

    User report a quit attempt

    Within 6 weeks after starting the first session of the intervention

Secondary Outcomes (2)

  • Number of sessions in preparation phase completed

    Within 6 weeks after starting the first session of the intervention

  • Number of sessions in preparation phase started

    Within 6 weeks after starting the first session of the intervention

Study Arms (2)

Negotiating quit date

EXPERIMENTAL

Endre: a digital smoking cessation counsellor

Other: Endre: a digital smoking cessation counsellor

Preset quit date

ACTIVE COMPARATOR

Endre: a digital smoking cessation counsellor

Other: Endre: a digital smoking cessation counsellor

Interventions

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).

Negotiating quit datePreset quit date

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Prague, Czechia

NOT YET RECRUITING

The Norwegian Centre for Addiction Research

Oslo, Norway

RECRUITING

Related Publications (1)

  • 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.

    PMID: 27354373BACKGROUND

Related Links

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Håvar Brendryen, PhD

    University of Oslo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Håvar Brendryen, PhD

CONTACT

99521714brendryen@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

June 19, 2017

First Posted

June 21, 2017

Study Start

September 12, 2017

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

October 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)NO(1)