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A Randomized Controlled Trial to Test the Effectiveness and Mechanisms of Change of a Video Game targeting Inhibitory Control in a Social Context among Smokers.


- candidate number27918
- NTR NumberNTR6706
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-sep-2017
- Secondary IDsECSW2017-1303-487 Ethics committee of the Faculty of Social Sciences of the Radboud University
- Public TitleA Randomized Controlled Trial to Test the Effectiveness and Mechanisms of Change of a Video Game targeting Inhibitory Control in a Social Context among Smokers.
- Scientific TitleA Randomized Controlled Trial to Test the Effectiveness and Mechanisms of Change of a Video Game targeting Inhibitory Control in a Social Context among Smokers.
- ACRONYM
- hypothesisThe effects of a video game targeting inhibitory control in a social context will be tested in a Dutch sample of adolescent- and young adult smokers (between the ages of 16 and 26). It is expected that the adolescents and young adults who receive the video game targeting inhibitory control in a social context will show smoke less cigarettes a week at post-test and follow-up, compared to the control group.
- Healt Condition(s) or Problem(s) studiedSmoking, Video game, Go/No-Go training, Response inhibition
- Inclusion criteriaAdolescents and young adults who are 1) between 16 and 26 years of age; 2) at least weekly smokers; 3) motivated to quit; and 4) willing to sign informed consent.
- Exclusion criteriaAdolescents and young adults who 1) use (psychoactive) medication or 2) are in current treatment of psychiatric disorder.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 13-sep-2017
- planned closingdate31-aug-2018
- Target number of participants144
- InterventionsAdolescent- and young adult smokers who are motivated to quit are randomly assigned to one of two conditions. The intervention condition will receive a video game targeting inhibitory control in a social context, which is a Go-NoGo training transformed into a video game format. There will be multiple play sessions at a mobile phone of 2-3 minutes at home. Participants will be beeped approximately once a day to play, but they are also instructed to play the game when they feel the urge to smoke or when they want to. The control condition (treatment-as-usual) will receive a self-help brochure by the Trimbos Institute to take home. This brochure, containing information about strategies for initiation and maintenance of cessation, can be considered standard treatment in the Netherlands.
- Primary outcomeSmoking: number of cigarettes per week / number of cigarettes per day
- Secondary outcomeInhibitory control:
1. Go/No-Go Task (behavioral and electrophysiological data)
Smoking cue-reactivity:
1. Viewing task (electrophysiological data)
2. Evaluation of pictures in training (behavioral data)
- Timepoints1. Screening
2. Pre-treatment: all primary and secondary outcomes (approximately one week before first session);
3. Post-treatment: all primary and secondary outcomes (approximately one week after last session);
4. Follow-up: only primary outcome (3- month)
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES H. Scholten
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Isabela Granic
- Sponsor/Initiator Radboud University Nijmegen, Behavioural Science Institute
- Funding
(Source(s) of Monetary or Material Support)
Radboud Universiteit Nijmegen, Behavioural Science Institute
- PublicationsN/A
- Brief summaryIn this randomized controlled trial the effects of a video game targeting inhibitory control in a social context will be tested in a Dutch sample of adolescent- and young adult smokers. Smokers who are motivated to quit are randomly assigned to one of two conditions. The intervention condition (video game) will consist of multiple short play sessions on a mobile phone of 2-3 minutes at home. The control condition (treatment-as-usual) will receive a self-help brochure by The Trimbos Institute containing information about strategies for initiation and maintenance of cessation. Measurements of primary and secondary outcomes will be conducted in both conditions at baseline, immediately following the intervention in laboratory visits. Primary outcomes will be conducted at 3-month follow-up as well.
- Main changes (audit trail)
- RECORD14-sep-2017 - 7-okt-2017


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