|- candidate number||21791|
|- NTR Number||NTR5096|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-mrt-2015|
|- Secondary IDs||2014-DP-3774; B300201422158; A14/0022 EC University of Amsterdam; MEC University of Antwerp; Belgian National Lottery|
|- Public Title||Train away your gambling problems: online cognitive bias training |
|- Scientific Title||Online Cognitive Bias Modification for Gambling Disorders: A randomised controlled trial|
|- ACRONYM||TOP-Gambling Project|
|- hypothesis||Hypothesis 1: Participants who receive either of two CBM interventions will reduce their gambling more than participants completing the placebo intervention immediately after the re-training (post-intervention assessment) and by the 3-and 6-month follow-ups. No substantial differences are expected between the two CBM interventions. |
Hypothesis 2: It is expected that each CBM intervention will decrease or reverse the targeted bias. The effect of each CBM paradigm over the non-targeted bias will be explored.
Hypothesis 3 (moderated mediation): In line with dual-process models of addiction and previous results of CBM studies in alcohol addiction (see Wiers, Gladwin, Hofmann, Salemink, & Ridderinkhof, 2013), it is expected that the change in the cognitive biases will mediate the change in the main outcome variable and that participants with stronger automatic cognitive biases and/or lower interference control ability at baseline will benefit more from the CBM intervention than participants with weaker automatic cognitive biases and/or stronger interference control.
|- Healt Condition(s) or Problem(s) studied||Gambling addiction|
|- Inclusion criteria||>18 years, gambled in the past 12 months, request for help for gambling problems (intrinsic motivation to treatment). |
|- Exclusion criteria||not being a Dutch or French native speaker, not having almost daily Internet access. |
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2015|
|- planned closingdate||1-dec-2017|
|- Target number of participants||178|
|- Interventions||The online training sessions start with an automated tailored feedback on participant's gambling motives and reasons to quit/reduce gambling, based on motivational interviewing approach. This is followed by Cognitive bias modification (CBM) training to reduce attentional bias (AB) or approach bias (AppB) toward preferred gambling-related cues and increase gambling cessation/reduction.
Condition 1: AB training|
Condition 2: AppB training
Condition 3: placebo AB or placebo AppB
|- Primary outcome||a) South-Oak Gambling Scale score (severity of gambling problems); b) frequency of gambling per month; c) average amount of money lost per month; c) greatest amount of money gambled on one day (question 1 of SOGS);
|- Secondary outcome||Craving, change in gambling-related attentional and approach bias from pre- to follow-up assessment sessions, depression symptoms (BDI-II short version). |
|- Timepoints||- Baseline assessment: gambling severity (SOGS), details about gambling behaviour, gambling disorder diagnosis based on DSM-5, preferred gambling activity, tailored feedback questionnaire, motivation to change (RCQ), depression (BDI-II short), substance use (CORE), impulsivity (BIS11), self-esteem (RSES), gambling approach bias (AAT) and attentional bias (VPT)m interference control capacity (Stroop Task);|
- Each training session (6 in total): Motivation to train, craving (VAS), CBM training
- Post-assessment: gambling severity (SOGS), gambling details, depression (BDI-II short), gambling approach bias (AAT) and attentional bias (VPT);
- 3-month follow-up: gambling severity (SOGS), gambling details, depression (BDI-II short), gambling approach bias (AAT) and attentional bias (VPT);
- 6-month follow-up: gambling severity (SOGS), gambling details, depression (BDI-II short).
|- Trial web site||www.impliciet.eu|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. Marilisa Boffo|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Marilisa Boffo|
|- Sponsor/Initiator ||University of Antwerp, University of Amsterdam (UvA)|
(Source(s) of Monetary or Material Support)
|Belgian National Lottery (LOTTO)|
|- Brief summary||This study is the first exploring the effectiveness of online Cognitive Bias Modification (CBM) interventions targeting maladaptive automatic processes underlying gambling disorders, i.e., the attentional bias and the approach bias towards gambling. |
The study is a pilot double blind randomised controlled trial with a parallel group design and involves at least 108 adults with gambling problems. Recruitment takes place via promotion of the study on gambling self-help websites and gambling and addiction help facilities around Belgium and the Netherlands.
At registration with the study website, participants are randomised into three experimental groups: two groups complete either the attentional bias CBM module or the approach bias CBM module and one group receives an active placebo re-training. The study consists of 10 sessions: one baseline assessment session with a tailored feedback on participants' gambling motives and reasons to quit/decrease gambling, six sessions of training, a post-intervention assessment session and two follow-up assessment sessions (after 3 and 6 months).
Gambling severity, details on gambling activities, craving, cognitive interference control capacity and the strength of the cognitive biases are assessed at each assessment session. At baseline, motivation to treatment, depression symptoms, substance and alcohol use, self-esteem and impulsivity are also assessed. Interference control capacity is evaluated by means of an automated version of the traditional Stroop Task. The attentional and approach bias towards gambling cues are assessed with a modified Visual Probe Task and an adapted version of the Approach-Avoidance Task, respectively. The experimental interventions present a modified version of the measurement tasks for the cognitive biases with a built-in contingency that recast them from assessment to re-training paradigms; whereas the (active) placebo intervention presents a longer version of the assessment tasks.
Primary outcome measure is the change in gambling problems severity between the situation before the trainings and the situation afterwards. Secondary outcome measures include change in depression symptoms and in the attentional and approach bias along the three measurement sessions.
|- Main changes (audit trail)|
|- RECORD||11-mrt-2015 - 12-feb-2017|