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Anxiety DisorderATTENTIONCT03764644

Web-based Attention Bias Modification Treatment for Childhood Anxiety Disorders

A study testing Combined ABMT and CBT in people with Anxiety Disorder and Anxiety Disorder of Childhood, run by Erasmus Medical Center at 1 site in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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%. Read more about this study

Who is it for?
Ages 8 to 16 years
What is being tested?
Combined ABMT and CBT
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
55 participants
Where
1 siteNetherlands
Study dates
Oct 2013to Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Eligible for participation are children (aged 8 to 16 years)
  • Primary diagnosis of separation anxiety disorder,
  • Primary diagnosis of generalized anxiety disorder
  • Primary diagnosis of specific phobia
  • Primary diagnosis of social phobia

Who cannot join

  • IQ below 85
  • poor command of the Dutch language
  • serious physical disease
  • psychosis
  • substance abuse
  • pervasive developmental disorder
Show all 13Show fewer
  • obsessive-compulsive disorder
  • posttraumatic stress disorder
  • acute stress disorder
  • panic disorder
  • major depression
  • anxiety medication during treatment
  • any concurrent psychotherapy

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • Erasmus MC - Sophia Children's Hospital

    Rotterdam, South Holland, 3000 CB

Other trials in Netherlands

About this study

Official title: Web-based Attention Bias Modification Treatment for Childhood Anxiety Disorders: a Randomized, Double-blind, Controlled Trial

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.

Read the detailed description

Anxiety disorders are the most prevalent psychiatric disorders, occurring in among 15% to 20% of children. Cognitive behavioral therapy (CBT) is currently the first-choice treatment for anxiety-disordered children. Despite proven efficacy, almost half of them do not respond, causing prolonged suffering. Children with persistent anxiety have an increased risk for other psychiatric disorders, school dropout, social isolation, alcoholism, and suicide attempts. Another concern is that only a small proportion of anxiety-disordered children actually receive treatment. These negative consequences in combination with the limited accessibility of treatment endorse the urgent need to develop more effective and accessible treatments that can enhance effectiveness of current treatment options.

A newly emerging and promising childhood anxiety treatment is Attention Bias Modification Treatment (ABMT). ABMT is build upon evidence that anxious children tend to selectively focus their attention on threatening information in the context of other non-threatening information, and that attention bias is related to development and maintenance of anxiety disorders. Children with an attention bias scan their environment for potential threat or danger thereby starting a cascade of subsequent processing biases in interpretation and memory, resulting in heightened anxiety.

Hence, as attention bias is an underlying mechanism of anxiety, treatment that diminishes attention bias toward threat in anxiety-disordered individuals should alleviate anxiety. Subsequently, several researchers began to examine the effect of ABMT, which implicitly trains anxiety-disordered individuals to attend away from threat toward neutral information. This is a different approach than CBT, which does not target early and automatic information processes, but addresses later stages of information processing that are under volitional control. Several studies highlighted the potential of ABMT in reducing anxiety levels in adults. A meta-analysis revealed that ABMT in adults produces significantly greater reductions in anxiety than sham control training, with a large effect size in clinical populations. A previous study found that 72% of the adults were free from their primary anxiety disorder after ABMT as compared to 11% after sham attention training, which is far more than CBT. These training effects were maintained at 4-month follow-up. Importantly, ABMT also modifies neural systems that are involved in the control of attention to emotional stimuli, in particular the lateral prefrontal cortex.

Despite the promising results in adults, ABMT has been scarcely examined in children. A few studies demonstrated a significant anxiolytic effect of ABMT, but not of the sham control condition. A major limitation of previous studies is that sample sizes were quite low and that a limited number of training sessions were provided. It has been shown that more training sessions enhance the magnitude of treatment effect. This is the first study that examines the effectiveness of a 9-session web-based ABMT in a large sample of anxiety-disordered children as well as examines the additive effect of web-based ABMT on CBT.

As reviewed above, childhood anxiety disorders are highly prevalent and debilitating, and there is an urgent need for improvement of current treatment strategies. An innovative, but scarcely examined, treatment option for childhood anxiety disorders is ABMT. A randomized, sham-controlled, double-blind trial of web-based Attention Bias Modification Treatment for childhood anxiety disorders will be conducted. One hundred twenty-eight children will be randomly allocated to a 9 session internet-delivered ABMT or sham attention training. 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.

Being tested
Combined ABMT and CBT, Combined Sham ABMT and CBT
Medical subject headings
Anxiety Disorders, Phobia, Specific, Phobia, Social, Generalized Anxiety Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined ABMT and CBTBehavioural

    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

  • Combined Sham ABMT and CBTBehavioural

    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

Study groups in NCT03764644
Study groupRoleWhat they receive
Combined ABMT and CBTExperimental9 sessions of Attention Bias Modification Treatment (dot-probe based of 160 trials) followed by individual Cognitive Behavioral Therapy via FRIENDS program
Receives: Behavioral: Combined ABMT and CBT
Combined Sham ABMT and CBTSham comparator9 sessions of Sham Attention Bias Modification Treatment (dot-probe based of 160 trials) followed by individual Cognitive Behavioral Therapy via FRIENDS program
Receives: Behavioral: Combined Sham ABMT and CBT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anxiety disorder status

    Free of any anxiety disorder according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)

    Measured: After 3 weeks of ABMT or sham-ABMT

  2. Anxiety disorder status

    Free of any anxiety disorder according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)

    Measured: After 10 weeks of CBT

  3. Anxiety disorder status

    Free of any anxiety disorder according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)

    Measured: 6 months follow-up (from last CBT session)

Secondary outcomes (9)
  1. Number of anxiety disorders

    Number of anxiety disorders according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)

    Measured: After 3 weeks of ABMT or sham-ABMT, after 10 weeks of CBT, 6 months follow-up

  2. Anxiety symptoms

    Total scale anxiety symptoms according to the Screen for Child Anxiety Related Emotional Disorders (SCARED-R), 69 items, range 0-138, higher score represents more symptoms

    Measured: After 3 weeks of ABMT or sham-ABMT, after 10 weeks of CBT, 6 months follow-up

  3. Depression symptoms

    Total scale depression symptoms according to the Child Depression Inventory (CDI), 27 items, range 0-54, higher score represents more symptoms

    Measured: After 3 weeks of ABMT or sham-ABMT, after 10 weeks of CBT, 6 months follow-up

  4. Number of anxiety disorders

    Number of anxiety disorders according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)

    Measured: After 10 weeks of CBT

  5. Anxiety symptoms

    Total scale anxiety symptoms according to the Screen for Child Anxiety Related Emotional Disorders (SCARED-R), 69 items, range 0-138, higher score represents more symptoms

    Measured: After 10 weeks of CBT

  6. Depression symptoms

    Total scale depression symptoms according to the Child Depression Inventory (CDI), 27 items, range 0-54, higher score represents more symptoms

    Measured: After 10 weeks of CBT

  7. Number of anxiety disorders

    Number of anxiety disorders according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)

    Measured: 6 months follow-up (from last CBT session)

  8. Anxiety symptoms

    Total scale anxiety symptoms according to the Screen for Child Anxiety Related Emotional Disorders (SCARED-R), 69 items, range 0-138, higher score represents more symptoms

    Measured: 6 months follow-up (from last CBT session)

  9. Depression symptoms

    Total scale depression symptoms according to the Child Depression Inventory (CDI), 27 items, range 0-54, higher score represents more symptoms

    Measured: 6 months follow-up (from last CBT session)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2018
  2. Study startOct 2013
  3. Primary completionFeb 2017
  4. Study completionJul 2017

Why it stopped: Interim results showed high futility to continue

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double blind, sham-controlled, randomized trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03764644
Sponsor's protocol ID
S13-11
Acronym
ATTENTIO
Status last verified
Dec 2018
First submitted
30 Nov 2018
Last updated
5 Dec 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Combined ABMT and CBT in people with Anxiety Disorder and Anxiety Disorder of Childhood, run by Erasmus Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Interim results showed high futility to continue). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety disorder status (time frame: After 3 weeks of ABMT or sham-ABMT). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.

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