|- candidate number||6049|
|- NTR Number||NTR1892|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-jul-2009|
|- Secondary IDs||MEC 08-3-003 Maastricht University/AZM|
|- Public Title||Relapse prevention for smoking cessation.|
|- Scientific Title||Relapse prevention for smoking cessation: testing explicit regulation processes using dismantling designs.|
|- hypothesis||Providing smokers (who are motivated to quit smoking) with personalised feedback (regarding smoking relapse, action planning and self efficacy) will be significantly more effective in preventing relapse than not providing any kind of feedback.
Providing multiple interactive feedback occasions is significantly more effective in preventing relapse than providing no feedback or a single feedback moment.|
|- Healt Condition(s) or Problem(s) studied||Smoking cessation, Relapse prevention, Internet based tailored advice|
|- Inclusion criteria||Daily smokers, between the age of 18-65, willing to quit individually within one month after they sign in for participation.|
|- Exclusion criteria||1. Not being a daily smoker;|
2. Smokers who have already quitted smoking;
3. Being younger than 18 years or older than 65 years.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||8-dec-2008|
|- planned closingdate||30-sep-2010|
|- Target number of participants||525|
|- Interventions||There are two intervention groups:|
1. Participants receive tailored feedback after filling in the baseline questionnaire and they fill in electronic diaries with assignments (three before the quit-attempt and three after the quit-attempt);
2. Same as intervention 1, however these participants also receive tailored feedback after the quit-attempt (11 times, during three months).
|- Primary outcome||Effect of the intervention on smoking relapse.
|- Secondary outcome||1. Effect of the intervention on smoking cesstion;|
2. Proces evaluation.
|- Timepoints||1. Baseline measurement;|
2. Six months follow-up;
3. Twelve months follow-up.
|- Trial web site||www.sq4u.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. Iman Elfeddali|
|- CONTACT for SCIENTIFIC QUERIES||Drs. Iman Elfeddali|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||At least 63 % of the smokers in the Netherlands have unsuccessfully tried to quit smoking one or more times. On average, only 7% of quit attempts are successful, while relapse rates are very high during the first week: 50 % during the first week and 62 % during the first two weeks. In our study we aim at analyzing the importance of concepts within health psychology that have not been explored fully to understand and change the process of relapse: e.g. action planning. Action planning refers to the process of goal setting. In order to test the efficacy of an internet-based tailoring program in which the concept of action planning is embedded, a RCT with 3 arms (N=525) is conducted to compare the effects of general action planning and interactive action planning. And, to compare these results with a control group at 6 and 12 months after the pretest. Self-reports will be validated. |
The study is conducted in the Netherlands among daily smokers, in the age of 18-65 years, willing to quit within a month.
|- Main changes (audit trail)|
|- RECORD||1-jul-2009 - 6-okt-2009|