| - candidate number | 1155 |
| - NTR Number | NTR94 |
| - ISRCTN | ISRCTN74423766 |
| - Date ISRCTN created | 12-sep-2005 |
| - date ISRCTN requested | 18-aug-2005 |
| - Date Registered NTR | 28-jul-2005 |
| - Secondary IDs | N/A |
| - 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. |
| - ACRONYM | Effectiveness of an online smoking cessation self-help intervention. A randomized clinical trial. |
| - hypothesis | 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. |
| - Healt Condition(s) or Problem(s) studied | Smoking cessation |
| - 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. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-aug-2005 |
| - planned closingdate | 31-jul-2007 |
| - Target number of participants | 1104 |
| - Interventions | 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 | 1. Abstinence; 2. Smoking in the last 7 days (point prevalence); 3. Incidence of quitting attempts of 24 hours or longer. |
| - Secondary outcome | 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). |
| - Timepoints | N/A |
| - Trial web site | http://www.stoppenmetrokenonderzoek.nl |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | Jeannet Kramer |
| - CONTACT for SCIENTIFIC QUERIES | Jeannet Kramer |
| - Sponsor/Initiator | Trimbos-institute - Netherlands Institute of Mental Health and Addiction |
| - Funding (Source(s) of Monetary or Material Support) | ZON-MW, The Netherlands Organization for Health Research and Development |
| - Publications | N/A |
| - Brief summary | In a randomized clinical trial (RCT) the effectiveness of an online smoking cessation self-help intervention will be compared to the effectiveness of an online smoking cessation brochure. The online self-help program consists of three components; 1. a smoking cessation module containing exercises which are based on cognitive behavioural therapy; 2. a discussion forum; 3. state-of-the art information and tips about smoking cessation. The control group gets access to an online smoking cessation brochure which advises on smoking cessation and gives information about withdrawal symptoms. Abstinence, smoking in the last 7 days (point prevalence), and incidence of quitting attempts of 24 hours or longer are the primary outcomes in this study. Measurements take place before the intervention and four and seven months after baseline. |
| - Main changes (audit trail) | |
| - RECORD | 28-jul-2005 - 9-dec-2009 |
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