Augmenting Effects of ABMT on CBT in Anxious Children: A Randomized Clinical Trial
Primary Purpose
Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive behavioral therapy for anxiety
Attention Bias Modification Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorder focused on measuring Attention bias modification treatment (ABMT), Attention biases, Anxious children, Cognitive Behavioral Therapy (CBT)
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Other
Placebo Comparator
Arm Label
ABMT + CBT
CBT Alone
ABMT placebo + CBT
Arm Description
CBT and ABMT
CBT alone (compare/control group)
ABMT placebo training and CBT
Outcomes
Primary Outcome Measures
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 in severity of anxiety symptoms (based on ADIS)
ADIS interview (see above)
Secondary Outcome Measures
SCARED parent/child
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}.
Full Information
NCT ID
NCT01730625
First Posted
November 9, 2012
Last Updated
November 15, 2012
Sponsor
Tel Aviv University
1. Study Identification
Unique Protocol Identification Number
NCT01730625
Brief Title
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
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder
Keywords
Attention bias modification treatment (ABMT), Attention biases, Anxious children, Cognitive Behavioral Therapy (CBT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABMT + CBT
Arm Type
Experimental
Arm Description
CBT and ABMT
Arm Title
CBT Alone
Arm Type
Other
Arm Description
CBT alone (compare/control group)
Arm Title
ABMT placebo + CBT
Arm Type
Placebo Comparator
Arm Description
ABMT placebo training and CBT
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy for anxiety
Intervention Type
Behavioral
Intervention Name(s)
Attention Bias Modification Treatment
Primary Outcome Measure Information:
Title
Change in frequency of anxiety symptoms (based on ADIS)
Description
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.
Time Frame
Change from baseline to up to 3 weeks after last treatment session
Title
Change in severity of anxiety symptoms (based on ADIS)
Description
ADIS interview (see above)
Time Frame
Change from baseline to up to 3 weeks after last treatment session
Secondary Outcome Measure Information:
Title
SCARED parent/child
Description
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}.
Time Frame
pre and post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yair Bar-Haim, Ph.D
Organizational Affiliation
Tel Aviv University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tomer Shechner, Ph.D
Organizational Affiliation
Tel Aviv University/Schneider children medical center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alan Apter, M.D.
Organizational Affiliation
Tel Aviv University/Schnider children medical center
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
22423353
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.
Results Reference
background
PubMed Identifier
24342386
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.
Results Reference
derived
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Augmenting Effects of ABMT on CBT in Anxious Children: A Randomized Clinical Trial
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