Attention Bias Modification Training in Youth With Subthreshold Impairing Anxiety

NCT ID: NCT02410967

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2018-03-30

Brief Summary

This study is a pilot test of Attention Bias Modification Training (ABMT) among clinic referred children and adolescents with subthreshold impairing anxiety (i.e., anxiety and related impairment that fails to meet criteria for an anxiety disorder diagnosis). Half of participants will receive 8 sessions of computer administered ABMT and the other half of participants will receive a 8 sessions of a computer administered control task.

Detailed Description

This study will collect preliminary data on Attention Bias Modification Training (ABMT) among clinic referred children and adolescents who display subthreshold impairing anxiety (SubImpAnx; anxiety & related impairment that fails to meet diagnostic criteria for an anxiety disorder). Traditional approaches to mental health service delivery cannot meet current demand. The inadequacies of traditional service delivery are magnified when viewed through the lens of impaired but undiagnosed youth. It is an unaddressed empirical question whether a least restrictive treatment can effectively reduce SubImpAnx in youth. Empirical efforts to address this issue are important because youths with SubImpAnx experience substantial impairment, are at high risk of escalation to full syndrome anxiety disorder, and pose a burden on the health care system.

This study will enroll 66 clinic referred children and adolescents (ages 8-16 years) who meet criteria for SubImpAnx. Participants will be randomly assigned to complete 8 sessions of either ABMT or a placebo control (PC) task over 4 weeks. Clinician ratings on youth anxiety severity and impairment will be evaluated as the primary outcome. Youth self ratings and parent ratings on youth anxiety symptoms and impairment will be evaluated as secondary outcomes. All measures will be collected before condition assignment (pretreatment), at immediate posttreatment, and at an 8 week follow up. In addition, initial data will be collected to shed light on whether it would be useful to pursue (a) attention bias to threat as a mediator of ABMT's anxiety reduction effects and (b) dose-response issues related to ABMT's anxiety reduction effects in a subsequent, larger study.

The specific aims are: Collect pilot data on the effects of ABMT and a PC task on levels of anxiety and impairment at a post evaluation (Aim 1) and at a follow up (FU) evaluation 8 weeks after the post evaluation (Aim 2); Preliminarily examine whether ABMT leads to lower levels of attention bias toward threatening stimuli as compared to a PC Task at post and 8 week FU (Aim 3); Describe the course of anxiety symptoms and impairment during treatment among youth in the ABMT condition (Aim 4).

This project will provide critically needed pilot data on ABMT for youth with SubImpAnx. With these data in hand, the field will be in a better position to determine whether ABMT may be used as a least restrictive intervention among anxious youth who are 'impaired but undiagnosed.'

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Attention Bias Modification

Attention Bias Modification is a computer-based attention training program.

Group Type: EXPERIMENTAL

Attention Bias Modification

Intervention Type: BEHAVIORAL

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

The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.

Group Type: PLACEBO_COMPARATOR

Placebo Attention Task

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 8-16 years old
• meet criteria for subthreshold impairing anxiety

Exclusion Criteria

• meet diagnostic criteria for Anxiety Disorder, 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeremy Pettit, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida International University

Locations

Florida International University Center for Children and Families

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UH2MH101470

Identifier Type: NIH

Identifier Source: org_study_id

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