Clinical trial NCT01730625: Augmenting Effects of ABMT on CBT in Anxious Children: A Randomized Clinical Trial
Official title: Augmenting Effects of Attention Bias Modification Treatment on Cognitive Behavioral Therapy in Anxious Children: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorder
Keywords: Attention bias modification treatment (ABMT)
Attention biases
Anxious children
Cognitive Behavioral Therapy (CBT)
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2012-11-21
Enrollment: 119
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The development of easily disseminated and efficacious treatment of psychiatric disorder is an important goal for translational neuroscience research. To that end, Attention Bias Modification Treatment (ABMT), a novel intervention targeting threat-related attention biases, has been shown to reduce anxiety in adults. To date, only one RCT study examined whether ABMT reduces clinical anxiety in children {Eldar, 2012 #32}, and no study has examined whether ABMT augments the efficacy of Cognitive Behavioral Treatment (CBT), the treatment of choice for anxiety disorders. Studying this question in youth is particularly important given that the onset of most anxiety disorders is during childhood, and early interventions may reduce long-term affliction. The current study is the first randomized control trial designed to examine the augmenting effects of ABMT on CBT among clinically anxious youth.

The purpose of Attention Bias Modification Therapy (ABMT) is to implicitly shape anxiety-related biases in attention orienting. ABMT uses the dot-probe task as a therapeutic tool. During training, the target location is systematically manipulated to increase the proportion of targets appearing at the location opposite the patient's bias. For example, in a training protocol intended to reduce threat bias, targets would appear more frequently at locations of neutral than threat stimuli.

Although CBT is an effective treatment for anxiety disorders, combining it with other treatment such as ABMT could result in additional treatment effects. CBT and ABMT are two interventions targeting different aspects of anxiety and therefore could potentially complement one another. While CBT modifies explicit and voluntary attention through verbal intervention, ABMT alters implicit and involuntary attentional biases. If ABMT augments CBT, the integration of the two treatments can have few significant benefits: First, it will combine the explicit learning of CBT with the implicit learning of ABMT and by that reduce the number of patients who respond poorly to CBT or do not respond at all. Second, computer-based training of attention may be more acceptable than traditional in-person therapy formats for some children and adolescents and can raise the cooperation in therapy. Finally, the CBT setting and the therapist presence can help to insure that ABMT is delivered consistently

The current study was designed to examine the ABMT augmentation effects on CBT for children with anxiety disorders. This study is the first randomized control trial in clinically anxious youth. Participants were randomly assigned to one of three conditions: 1. Training condition (CBT+ABMT), 2. Placebo condition (CBT+ ABMT-Placebo) 3. Control condition (CBT alone). We hypothesize that participants in the training condition will show the greatest improvement in anxiety symptoms.


Eligibility criteria: Inclusion Criteria:

1. Children ranging in age from 6 - 18 year
2. At least one clinical diagnoses of either separation anxiety disorder (SAD), social phobia (SP), specific phobia, or generalized anxiety disorder (GAD) (American Psychiatric Association \[APA\], 1994)

Exclusion Criteria:

1. Lifetime history of psychosis
2. Child's inability to comply to CBT
3. Diagnosis of post traumatic stress disorder (PTSD), diagnosis of obsessive compulsive disorder (OCD), or selective mutism

Primary outcomes:
measure: Change in frequency of anxiety symptoms (based on ADIS)
timeFrame: Change from baseline to up to 3 weeks after last treatment session
measure: Change in severity of anxiety symptoms (based on ADIS)
timeFrame: Change from baseline to up to 3 weeks after last treatment session
Secondary outcomes:
measure: SCARED parent/child
timeFrame: pre and post treatment
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv University
name: Yair Bar-Haim, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel Aviv University/Schneider children medical center
name: Tomer Shechner, Ph.D
role: STUDY_DIRECTOR
affiliation: Tel Aviv University/Schnider children medical center
name: Alan Apter, M.D.
role: STUDY_CHAIR
References:
citation: Eldar S, Apter A, Lotan D, Edgar KP, Naim R, Fox NA, Pine DS, Bar-Haim Y. Attention bias modification treatment for pediatric anxiety disorders: a randomized controlled trial. Am J Psychiatry. 2012 Feb;169(2):213-20. doi: 10.1176/appi.ajp.2011.11060886.
citation: Shechner T, Rimon-Chakir A, Britton JC, Lotan D, Apter A, Bliese PD, Pine DS, Bar-Haim Y. Attention bias modification treatment augmenting effects on cognitive behavioral therapy in children with anxiety: randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2014 Jan;53(1):61-71. doi: 10.1016/j.jaac.2013.09.016. Epub 2013 Oct 10.