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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yair Bar-Haim, Tel Aviv University
ClinicalTrials.gov Identifier:
NCT01730625
First received: November 9, 2012
Last updated: November 15, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Anxiety Disorder
Behavioral: Cognitive behavioral therapy for anxiety
Behavioral: Attention Bias Modification Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Augmenting Effects of Attention Bias Modification Treatment on Cognitive Behavioral Therapy in Anxious Children: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Tel Aviv University:

Primary Outcome Measures:
  • Change in frequency of anxiety symptoms (based on ADIS) [ Time Frame: Change from baseline to up to 3 weeks after last treatment session ] [ Designated as safety issue: No ]
    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 in severity of anxiety symptoms (based on ADIS) [ Time Frame: Change from baseline to up to 3 weeks after last treatment session ] [ Designated as safety issue: No ]
    ADIS interview (see above)


Secondary Outcome Measures:
  • SCARED parent/child [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]
    The SCARED-R is 41- items parent and child reported questionnaire, measuring DSM-IV defined anxiety disorder symptoms in children. The scale measures symptoms of separation anxiety, generalized anxiety disorder, panic disorder, social phobia and school phobia. SCARED-R total and subscale scores can be obtained by summing across relevant items. The SCARED-R is a valid and reliable child anxiety instrument {Muris, 2001 #2;Muris, 2001 #3;Muris, 1999 #4} that has been extensively used in clinical and research contexts in Israel {Eldar, 2012 #32}.


Enrollment: 119
Study Start Date: October 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABMT + CBT
CBT and ABMT
Behavioral: Cognitive behavioral therapy for anxiety Behavioral: Attention Bias Modification Treatment
CBT Alone
CBT alone (compare/control group)
Behavioral: Cognitive behavioral therapy for anxiety
Placebo Comparator: ABMT placebo + CBT
ABMT placebo training and CBT
Behavioral: Cognitive behavioral therapy for anxiety

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01730625

Sponsors and Collaborators
Tel Aviv University
Investigators
Principal Investigator: Yair Bar-Haim, Ph.D Tel Aviv University
Study Director: Tomer Shechner, Ph.D Tel Aviv University/Schneider children medical center
Study Chair: Alan Apter, M.D. Tel Aviv University/Schnider children medical center
  More Information

Publications:
Responsible Party: Yair Bar-Haim, Prof. Yair Bar-Haim, Ph.D., Tel Aviv University
ClinicalTrials.gov Identifier: NCT01730625     History of Changes
Other Study ID Numbers: ABMT-RCT
Study First Received: November 9, 2012
Last Updated: November 15, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Tel Aviv University:
Attention bias modification treatment (ABMT)
Attention biases
Anxious children
Cognitive Behavioral Therapy (CBT)

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014