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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: Netherlands Trial Register
Last refreshed on: 28 April 2013
Main ID:  NTR94
Date of registration: 28/07/2005
Primary sponsor: Trimbos-institute - Netherlands Institute of Mental Health and Addiction
Public title: Effectiveness of an online smoking cessation self-help intervention. A randomized clinical trial.
Scientific title: Effectiveness of an online smoking cessation self-help intervention to help smokers quit smoking. A randomized clinical trial. - Effectiveness of an online smoking cessation self-help intervention. A randomized clinical trial.
Date of first enrolment: 1/8/2005
Target sample size: 1104
Recruitment status: complete
URL:  http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=94
Study type:  intervention
Study design:  Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized  
Countries of recruitment
The Netherlands
Contacts
Name: Jeannet  Kramer
Address:  Trimbos Institute - The Netherlands, Institute for Mental Health and Addiction. Centre for Prevention and Brief Intervention, P.O. Box 725, Da Costakade 45 3500 AS Utrecht The Netherlands
Telephone: +31 (0)30 2959380
Email: jkramer@trimbos.nl
Affiliation: 
Name: Jeannet  Kramer
Address:  Trimbos Institute - The Netherlands, Institute for Mental Health and Addiction. Centre for Prevention and Brief Intervention, P.O. Box 725, Da Costakade 45 3500 AS Utrecht The Netherlands
Telephone: +31 (0)30 2959380
Email: jkramer@trimbos.nl
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Subjects are included if they:

1. Are 18 years or older;

2. Are currently smoking cigarettes or rolling tobacco;

3. Intend to quit smoking within a month;

4. Have access to the Internet.

Exclusion criteria: Subjects are excluded when they:

1. Do not meet the inclusion criteria;

2. Are already preparing a quitting attempt with the help of a counsellor or course;

3. Are already preparing a quitting attempt with help of pharmacotherapy;

4. Are involved in another (experimental) study with an interfering design or interfering goals.


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Smoking cessation

Intervention(s)
The online self-help smoking cessation program consists of three components;
1. A smoking cessation module containing exercises which are based on cognitive behavioural therapy;
2. A discussion forum, and
3. State-of-the art information and tips about smoking cessation.

The control group gets access to an online smoking cessation brochure (?Quit smoking; why and how?) which advises on smoking cessation and gives information about withdrawal symptoms. Each intervention can be used in accordance with their needs.

Both interventions are developed by STIVORO.
Primary Outcome(s)
1. Abstinence;

2. Smoking in the last 7 days (point prevalence);

3. Incidence of quitting attempts of 24 hours or longer.
Secondary Outcome(s)
1. Decrease of the daily cigarette consumption;

2. Number of quitting attempts of 24 hours or longer;

3. Stage transition in the stage-of-change (motivational stadium).
Secondary ID(s)
ISRCTN74423766
N/A
Source(s) of Monetary Support
ZON-MW, The Netherlands Organization for Health Research and Development
Secondary Sponsor(s)
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