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Interim results showed high futility to continue
ATTENTIO
Sponsor study identifier
interventional
55
1 country
1
Study Start
October 2013
Actual (reported)Primary Completion
February 2017
Actual (reported)Study Completion
July 2017
Actual (reported)Anxiety disorders are the most common childhood psychiatric disorders, with prevalence rates as high as 15% to 20%. Success rates of the first choice treatment strategy (i.e. Cognitive Behavioural Therapy; CBT) are around 50%. Non-response increases the risk for other psychiatric disorders, school dropout, social isolation, alcoholism, and suicide attempts. These negative consequences endorse the urgent need to develop more effective and accessible treatments that enhance effectiveness of current treatment options. A promising new treatment for childhood anxiety disorders is Attention Bias Modification Treatment (ABMT). ABMT is based on evidence that anxiety-disordered individuals selectively allocate their attention toward threatening information (i.e. attention bias). This bias in early and automatic attention processes starts a cascade of subsequent biases in information processing and memory, resulting in heightened anxiety. Attention bias is an underlying mechanism of anxiety. Thus ABMT, which implicitly trains individuals to attend away from threatening information should alleviate anxiety. In contrast to ABMT, CBT explicitly targets later stages of information processing that are under volitional control. Meta-analyses of studies in adults have shown that ABMT indeed results in increased recovery rates and clinically significant changes in anxiety, compared to so-called "sham" attention training (control condition). Imaging studies have shown that ABMT modifies lateral prefrontal cortex activity to emotional stimuli. Despite its promising results, fewer studies have examined ABMT in anxiety-disordered children. The aim of this trial is to enhance treatment effectiveness by combining web-based ABMT with CBT in a large sample of anxiety-disordered children. The primary aim is to compare ABMT-augmented CBT with CBT as monotherapy on recovery rates for anxiety disorders and changes in anxiety. The secondary aim is to compare ABMT with sham attention training on anxiety disorder recovery rates and changes in anxiety. We hypothesize that (1) ABMT-augmented CBT will result in a significantly better treatment success than CBT alone, and (2) ABMT will result in a significantly better treatment success than sham attention training. The design will be a randomized, double-blind, sham-controlled clinical trial.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2013
Actual (reported)February 2017
Actual (reported)July 2017
Actual (reported)November 30, 2018
Actual (reported)December 5, 2018
Actual (reported)Anxiety disorder status
Free of any anxiety disorder according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)
After 3 weeks of ABMT or sham-ABMT
Anxiety disorder status
Free of any anxiety disorder according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)
After 10 weeks of CBT
Anxiety disorder status
Free of any anxiety disorder according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)
6 months follow-up (from last CBT session)
9 sessions of Attention Bias Modification Treatment (dot-probe based of 160 trials) followed by individual Cognitive Behavioral Therapy via FRIENDS program
9 sessions of Sham Attention Bias Modification Treatment (dot-probe based of 160 trials) followed by individual Cognitive Behavioral Therapy via FRIENDS program
ABMT: A trial begins with a fixation cross (+) for 500 ms, immediately followed by a stimuli pair consisting of a neutral and threatening stimulus that is centred horizontally. Stimuli pairs consist of two faces, pictures or words. After presentation of the stimuli pair, a probe (: or ..) always appears on the location of the neutral stimulus. The probe remains on the screen until the participant presses the corresponding key (: or ..), after which the next trial begins. Each session, participants see 160 trials of which 128 trials include one neutral and one threatening stimulus. The remaining 32 trials include a neutral-neutral stimuli pair. CBT: FRIENDS program individual
Erasmus MC - Sophia Children's Hospital
Rotterdam, South Holland, 3000 CB, Netherlands
Jeroen Legerstee, PhD
Erasmus Medical Center
55 participants (actual enrollment reported by the registry).
First Submitted
November 30, 2018
First Posted
December 5, 2018
Study Start
October 2013
Number of anxiety disorders
After 3 weeks of ABMT or sham-ABMT, after 10 weeks of CBT, 6 months follow-up
Anxiety symptoms
After 3 weeks of ABMT or sham-ABMT, after 10 weeks of CBT, 6 months follow-up
Depression symptoms
After 3 weeks of ABMT or sham-ABMT, after 10 weeks of CBT, 6 months follow-up
Number of anxiety disorders
After 10 weeks of CBT
Anxiety symptoms
After 10 weeks of CBT
ABMT: A trial begins with a fixation cross (+) for 500 ms, immediately followed by a stimuli pair consisting of a neutral and threatening stimulus that is centred horizontally. Stimuli pairs consist of two faces, pictures or words. After presentation of the stimuli pair, a probe (: or ..) always appears on the location of the neutral stimulus. The probe remains on the screen until the participant presses the corresponding key (: or ..), after which the next trial begins. Of the 160 trials, the probe appears with equal frequency on the location of the neutral and threatening stimulus (128 trials). The remaining 32 trials include a neutral-neutral stimuli pair. CBT: FRIENDS program individual
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Primary Completion
February 2017
Actual (reported)Study Completion
July 2017
Actual (reported)Last Updated
December 5, 2018
Record last verified: 2018-12
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Source: ClinicalTrials.gov.
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