Web-based Attention Bias Modification Treatment for Childhood Anxiety Disorders

NCT03764644 | Terminated DMC

• 1 other identifier: S13-11
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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%. 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.

Conditions

Anxiety Disorder; Anxiety Disorder of Childhood; Separation Anxiety Disorder of Childhood, Early Onset; Specific Phobia; Social Anxiety Disorder; Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (9)

• 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

Study Arms (2)

Combined ABMT and CBT

EXPERIMENTAL

9 sessions of Attention Bias Modification Treatment (dot-probe based of 160 trials) followed by individual Cognitive Behavioral Therapy via FRIENDS program

Behavioral: Combined ABMT and CBT

Combined Sham ABMT and CBT

SHAM COMPARATOR

9 sessions of Sham Attention Bias Modification Treatment (dot-probe based of 160 trials) followed by individual Cognitive Behavioral Therapy via FRIENDS program

Behavioral: Combined Sham ABMT and CBT

Interventions

Combined ABMT and CBT BEHAVIORAL

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 ABMT and CBT

Combined Sham ABMT and CBT BEHAVIORAL

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

Combined Sham ABMT and CBT

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC - Sophia Children's Hospital

Rotterdam, South Holland, 3000 CB, Netherlands

Location

MeSH Terms

Conditions

Anxiety Disorders; Phobia, Specific; Phobia, Social; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders

Study Officials

• Jeroen Legerstee, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double blind, sham-controlled, randomized trial

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 5, 2018
• Study Start: October 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 5, 2018

Record last verified: 2018-12

Locations

NL (1)