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

NCT01730625 | Completed

• 1 other identifier: ABMT-RCT
• Study Type: interventional
• Target: 119
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (2)

• Change in frequency of anxiety symptoms (based on ADIS)

  Diagnosis was established with a structured psychiatric interview, the ADIS for DSM-IV: C/P {Albano, 1996 #17}, which assesses the major anxiety, mood, and externalizing DSM-IV disorders experienced by children. The ADIS possesses excellent test-retest reliability for both symptom scales and diagnoses {Silverman, 2001 #1}, and has been translated to Hebrew and back translated in collaboration with the original authors. Interviewers were psychology graduate students who were trained on ADIS administration for couple of weeks. Two experienced clinical psychologist provided supervision for the interviewers on clinical issues that arise during these diagnostic assessments.

  Change from baseline to up to 3 weeks after last treatment session

• Change in severity of anxiety symptoms (based on ADIS)

  ADIS interview (see above)

  Change from baseline to up to 3 weeks after last treatment session

Secondary Outcomes (1)

• SCARED parent/child

  pre and post treatment

Study Arms (3)

ABMT + CBT

EXPERIMENTAL

CBT and ABMT

Behavioral: Cognitive behavioral therapy for anxiety; Behavioral: Attention Bias Modification Treatment

CBT Alone

OTHER

CBT alone (compare/control group)

Behavioral: Cognitive behavioral therapy for anxiety

ABMT placebo + CBT

PLACEBO COMPARATOR

ABMT placebo training and CBT

Behavioral: Cognitive behavioral therapy for anxiety

Interventions

Cognitive behavioral therapy for anxiety BEHAVIORAL

ABMT + CBT; ABMT placebo + CBT; CBT Alone

Attention Bias Modification Treatment BEHAVIORAL

ABMT + CBT

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children ranging in age from 6 - 18 year
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Tel Aviv University: lead

Related Publications (2)

• 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.

  PMID: 22423353 BACKGROUND

• 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.

  PMID: 24342386 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Yair Bar-Haim, Ph.D

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

• Tomer Shechner, Ph.D

  Tel Aviv University/Schneider children medical center

  STUDY DIRECTOR

• Alan Apter, M.D.

  Tel Aviv University/Schnider children medical center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Yair Bar-Haim, Ph.D.

Study Record Dates

• First Submitted: November 9, 2012
• First Posted: November 21, 2012
• Study Start: October 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 21, 2012

Record last verified: 2012-11