|- candidate number||8033|
|- NTR Number||NTR2312|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-apr-2010|
|- Secondary IDs||08-3-003 MEC 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||Giving smokers (who are motivated to quit smoking) an attentional retraining to train away the attention they have for smoking related stimuli will be significantly more effective in preventing smoking relapse than giving them a non-training version of the task. |
|- Healt Condition(s) or Problem(s) studied||Smoking cessation, Relapse prevention, Attentional retraining|
|- 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. Being a non daily smoker;|
2. Not being in the age of 18-65 years;
3. Not willing to quit within one month;
4. Using anti-depressiva, sleeping pills, soft or hard drugs;
5. Drinking more than 16 glasses of alcohol;
6. Being dyslectic;
7. Being color blind or not seeing well even with corrections;
8. Not understanding Dutch.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-dec-2009|
|- planned closingdate||15-jan-2011|
|- Target number of participants||325|
|- Interventions||ATTENTIONAL RETRAINING: Smokers will receive an internet-based attentional retraining. The training consists of trials in which participants are shown a smoking-related and neutral stimulus on screen. The attention of the participants is drawn to the neutral stimulus by having an arrow appearing behind the neutral stimulus and unlearning them to have attention for smoking related stimuli. The participants are asked to react on the arrow by using the keybord.
The first and last session consist of tasks measuring attentional bias. The training is supposed to reduce the attentional bias and lead to smoking abstinence.
Participants in the non-training session receive a measurement instead of a training (arrow appears behind the smoking related stimulus in 50% of the trials, and behind the neutral stimulis in the other 50% of the trials).
|- Primary outcome||Decrease in attentional bias is measured in the last session of the intervention. The bias is measured using attentional bias tasks. The behavioral effects are measured using questionnaires, by asking the participants about their smoking behavior.
At the three, six and twelve months follow-up the effects on smoking abstinence are measured using questionnaires.|
|- Secondary outcome||The secondary outcomes are the results of a process evaluation on how the participants experienced participation to the study.|
|- Timepoints||1. Baseline measurement;|
2. Three months;
3. Six months follow-up;
3. Twelve months follow-up.
|- Trial web site||www.trainjezelfrookvrij.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 in the first week after the quit-attempt. In our study we aim at analyzing the importance of concepts that have not been explored fully to understand and change the process of relapse: e.g. implicit cognitions.
Most health education interventions are based on the hypothesis that behavior is caused by controlled processes. Recently, researchers have begun to use indirect or implicit measures to assess drug-related cognitions. It may be possible to directly modify implicit drug-related cognitions. Studies have already indicated that attentional bias predicted relapse in alcoholics and smokers. An attentional bias means that attention is automatically drawn to the drug-related stimulus (in this case smoking in comparison with a neutral stimulus). An attentional bias is measured using reaction tests to smoking and non-smoking stimuli. Attentional retraining implies unlearning the automatic attentional bias for drug-related stimuli.
|- Main changes (audit trail)|
|- RECORD||28-apr-2010 - 16-mei-2010|