Attention Bias Modification Training for Child Anxiety CBT Nonresponders

Anxiety Disorders Clinical Trial

Official title:

Attention Bias Modification Training for Child Anxiety CBT Nonresponders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819311
• Other study ID #: MH097931
• Status: Completed
• Phase: N/A
• First received: March 12, 2013
• Last updated: September 20, 2017
• Start date: April 1, 2013
• Est. completion date: June 23, 2017

Study information

• Verified date: September 2017
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project will test Attention Bias Modification Training (ABMT) among children and adolescents who have completed a full protocol of cognitive behavior therapy (CBT) for anxiety and still meet criteria for a primary diagnosis of an anxiety disorder. The purpose of this project is to determine whether ABMT leads to reductions in anxiety and related impairment, relative to a placebo task condition.

Description:

This application proposes a pilot test of Attention Bias Modification Training (ABMT) among children and adolescents who have completed a full protocol of cognitive behavior therapy (CBT) for anxiety and still meet criteria for a primary diagnosis of an anxiety disorder a full year after completion of CBT. There is currently not a single empirical study in the youth anxiety treatment literature that has systematically examined a treatment augment for youth who fail to respond to a full course of CBT. Empirical efforts to address this issue are important because youths who do not respond to CBT continue to suffer emotional distress and impairment associated with anxiety disorders, experience frustration and demoralization by perceived "failure," and likely pose a financial burden on the health care system.

ABMT is a novel translational treatment for anxiety based on experimental and neuroscience research findings on attention processes. Research demonstrates that ABMT leads to reductions in anxiety and its disorders. Based on recent theory and research demonstrating an attention bias toward threat predicts CBT nonresponse among anxious youth, researchers have postulated that ABMT may hold promise as an augment to CBT because of its specific focus on attention bias that targets both frontal-cortical and subcortical circuitry.

This study will recruit an estimated 70 children and adolescents who have completed a 12-14 week CBT trial for anxiety disorders and at the one year follow-up continue to meet criteria for a primary diagnosis of an anxiety disorders. These 70 children and adolescents (ages 8-16 years) will be randomly assigned to complete eight biweekly sessions of either ABMT or a placebo control (PC) task. Clinician ratings on youth anxiety severity will be collected and evaluated as the primary outcome. Youth self ratings on anxiety symptoms and parent ratings on youth anxiety symptoms will be collected and evaluated as secondary outcomes. All measures will be collected before condition assignment (pretreatment), at immediate posttreatment, and at an eight week follow up. The following specific aims will be addressed.

Aim 1: Test whether ABMT leads to significantly lower levels of anxiety at posttreatment as compared to a Placebo Control Task.

Aim 2: Examine whether ABMT leads to significantly lower levels of anxiety as compared to a Placebo Control Task at a follow up evaluation eight weeks posttreatment. This would suggest the maintenance of ABMT effects after eight weeks of no treatment.

Aim 3: Gain perspective on the viability of variables as potential mediators and moderator of ABMT so as to inform decisions about whether to pursue these variables in a future R01. The variables proposed as potential mediators are attention bias toward threat and threat-related interpretation bias. The variable proposed as a potential moderator is attention control.

Overall, this project will provide critically needed data on ABMT as a treatment augment for youth with anxiety disorders who do not respond CBT. With these data in hand, the field will be in a better position to determine whether and how ABMT may be used optimally among anxious youth who are likely to need more than CBT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 23, 2017
• Est. primary completion date: June 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

Inclusion Criteria:

• 8-16 years old

• completed a 12-14 week cognitive behavioral therapy for anxiety

• a primary DSM-IV diagnosis of generalized anxiety disorder, social anxiety disorder, or separation anxiety disorder

• if other psychiatric disorders are present, they must be treated with medication and stable

Exclusion Criteria:

• meet diagnostic criteria for Organic Mental Disorders, Psychotic Disorders, Pervasive Developmental Disorders, or Mental Retardation

• a high likelihood of harming self or others

• not been living with a primary caregiver for at least 6 months who is legally able to give consent for the child's participation

• previously undisclosed abuse requiring investigation or ongoing supervision by the Department of Social Services;

• involved currently in another psychosocial/behavioral treatment

• a serious vision problem that is not corrected with prescription lenses

• a physical disability that interferes with the ability to click a mouse button rapidly and repeatedly

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• Attention Bias Modification
At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders.
• Placebo Attention Task
At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability.

Locations

Country	Name	City	State
United States	Florida International University Center for Children and Families	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida International University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Rating on the Pediatric Anxiety Rating Scale	The Pediatric Anxiety Rating Scale (PARS) assesses global anxiety severity across social anxiety disorder, separation anxiety disorder, and generalized anxiety disorder in youth ages 6-17 years. An independent evaluator rates anxiety symptoms on 7 dimensions (i.e., number of symptoms, severity of distress, severity of physical symptoms, frequency, avoidance, interference at home, and interference out of home). Each dimension is rated from 0 to 5. Total scores range from 0 to 35, with higher scores indicating greater anxiety severity.	post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)
Primary	Clinician Rating on the Pediatric Anxiety Rating Scale	The Pediatric Anxiety Rating Scale (PARS) assesses global anxiety severity across social anxiety disorder, separation anxiety disorder, and generalized anxiety disorder in youth ages 6-17 years. An independent evaluator rates anxiety symptoms on 7 dimensions (i.e., number of symptoms, severity of distress, severity of physical symptoms, frequency, avoidance, interference at home, and interference out of home). Each dimension is rated from 0 to 5. Total scores range from 0 to 35, with higher scores indicating greater anxiety severity.	8-week follow-up
Secondary	Screen for Child Anxiety Related Emotional Disorders - Parent Version	The Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P) assesses anxiety symptom severity in youth ages 6-17 years. The parent rates youth anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.	post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)
Secondary	Screen for Child Anxiety Related Emotional Disorders - Child Version	The Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C) assesses anxiety symptom severity in youth ages 6-17 years. The child rates his or her anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.	post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)
Secondary	Screen for Child Anxiety Related Emotional Disorders - Parent Version	The Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P) assesses anxiety symptom severity in youth ages 6-17 years. The parent rates youth anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.	8-week follow-up
Secondary	Screen for Child Anxiety Related Emotional Disorders - Child Version	The Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C) assesses anxiety symptom severity in youth ages 6-17 years. The child rates his or her anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.	8-week follow-up