Effectiveness of an online smoking cessation self-help intervention. A randomized clinical trial.

ISRCTN	ISRCTN74423766
DOI	https://doi.org/10.1186/ISRCTN74423766
Secondary identifying numbers	N/A

Submission date: 12/09/2005
Registration date: 12/09/2005
Last edited: 28/01/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Ms Jeannet Kramer
Scientific

Trimbos Institute - The Netherlands Institute for Mental Health and Addiction
Centre for Prevention and Brief Intervention
P.O. Box 725
Utrecht
3500 AS
Netherlands

Phone	+31 (0)30 2959380
Email	jkramer@trimbos.nl

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	Compared to an online smoking cessation brochure, does participation in an online self-help smoking cessation program lead to: 1. A greater percentage successful quitters, three and six months after the start of the intervention 2. A greater percentage of quitting attempts
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Smoking cessation
Intervention	The online self-help smoking cessation program consists of three components: 1. Smoking cessation module containing exercises which are based on cognitive behavioural therapy 2. Discussion forum 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.
Intervention type	Other
Primary outcome measure	1. Abstinence 2. Smoking in the last 7 days (point prevalence) 3. Incidence of quitting attempts of 24 hours or longer
Secondary outcome measures	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 stage)
Overall study start date	01/08/2005
Completion date	31/07/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	1104
Key inclusion criteria	1. Patients that are 18 years or older 2. Currently smoking cigarettes or rolling tobacco 3. Intend to quit smoking within a month 4. Have access to the Internet
Key exclusion criteria	1. Patients that 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
Date of first enrolment	01/08/2005
Date of final enrolment	31/07/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Trimbos Institute - The Netherlands Institute for Mental Health and Addiction

Utrecht
3500 AS
Netherlands

Sponsor information

Trimbos Institute (The Netherlands)
Charity

Da Costakade 45 Postbus 725
Utrecht
3500 AS
Netherlands

"ROR"	https://ror.org/02amggm23

Funders

Funder type

Research council

ZON-MW, The Netherlands Organization for Health Research and Development

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	22/01/2009		Yes	No