Augmenting Effects of ABMT on CBT in Anxious Children: A Randomized Clinical Trial

NCT ID: NCT01730625

Last Updated: 2012-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-07-31

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.

Conditions

Anxiety Disorder

Keywords

Attention bias modification treatment (ABMT); Attention biases; Anxious children; Cognitive Behavioral Therapy (CBT)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ABMT + CBT

CBT and ABMT

Group Type: EXPERIMENTAL

Cognitive behavioral therapy for anxiety

Intervention Type: BEHAVIORAL

Attention Bias Modification Treatment

Intervention Type: BEHAVIORAL

CBT Alone

CBT alone (compare/control group)

Group Type: OTHER

Cognitive behavioral therapy for anxiety

Intervention Type: BEHAVIORAL

ABMT placebo + CBT

ABMT placebo training and CBT

Group Type: PLACEBO_COMPARATOR

Cognitive behavioral therapy for anxiety

Intervention Type: BEHAVIORAL

Interventions

Cognitive behavioral therapy for anxiety

Intervention Type: BEHAVIORAL

Attention Bias Modification Treatment

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel Aviv University

OTHER

Sponsor Role: lead

Responsible Party

Yair Bar-Haim

Prof. Yair Bar-Haim, Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yair Bar-Haim, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv University

Tomer Shechner, Ph.D

Role: STUDY_DIRECTOR

Tel Aviv University/Schneider children medical center

Alan Apter, M.D.

Role: STUDY_CHAIR

Tel Aviv University/Schnider children medical center

References

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.

Reference Type: BACKGROUND

PMID: 22423353 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24342386 (View on PubMed)

Other Identifiers

ABMT-RCT

Identifier Type: -

Identifier Source: org_study_id