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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
Tel Aviv University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

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

    First Posted
    November 9, 2012
    Last Updated
    November 15, 2012
    Sponsor
    Tel Aviv University
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    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

    Learn more about this trial

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

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