A Clinical Trial of a Gamified Attention Bias Modification Training in Anxious Youth

Anxiety Disorders Clinical Trial

Official title:

A Clinical Trial of a Gamified Attention Bias Modification Training in Anxious Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03283930
• Other study ID #: 0192A
• Status: Completed
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: September 1, 2023

Study information

• Verified date: November 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Attention bias modification training (ABMT) and cognitive behavioral therapy (CBT) likely target different aspects of aberrant threat responses in anxiety disorders and may be combined to maximize therapeutic benefit. However, studies investigating the effect of ABMT in the context of CBT have yielded mixed results.

Objective: The primary goal of this project is to utilize an enhanced ABMT to target attentional bias towards threat, in addition to classic CBT for anxiety disorders in youth, to determine the efficacy of ABMT in the context of CBT.

Study Population: 121 youth (8-17 years old) with a primary anxiety disorder diagnosis

Methods: In this sub-study,

• Participants will receive open CBT treatment.

• Open CBT treatment will be augmented with computer-based attention retraining, delivered in a randomized-controlled design, with random assignment to either active or placebo attention-training regimens.

• This enhanced ABMT integrates a modified dot-probe task used in previous studies, where a target is always presented at the previous location of the neutral and not the simultaneously presented threatening stimulus, with a visual search, where the targets are always presented distally of threatening distractors.

• These two training elements (modified dot-probe and visual search) will be embedded in an engaging game to foster motivation and adherence.

Outcome: Symptom improvement will be compared between the two study arms.

Description:

Background: Attention bias modification training (ABMT) and cognitive behavioral therapy (CBT) likely target different aspects of aberrant threat responses in anxiety disorders and may be combined to maximize therapeutic benefit. However, studies investigating the effect of ABMT in the context of CBT have yielded mixed results.

Objective: The primary goal of this project is to utilize an enhanced ABMT to target attentional bias towards threat, in addition to classic CBT for anxiety disorders in youth, to determine the efficacy of ABMT in the context of CBT.

Study Population: 121 youth (8-17 years old) with a primary anxiety disorder diagnosis who are originally consented on 01-M-0192 will be recruited and randomized to each arm in the sub-study

Methods: In this sub-study,

• Participants will receive open CBT treatment.

• Open CBT treatment will be augmented with computer-based attention retraining, delivered in a randomized-controlled design, with random assignment to either active or placebo attention-training regimens.

• This enhanced ABMT integrates a modified dot-probe task used in previous studies, where a target is always presented at the previous location of the neutral and not the simultaneously presented threatening stimulus, with a visual search, where the targets are always presented distally of threatening distractors.

• These two training elements (modified dot-probe and visual search) will be embedded in an engaging game to foster motivation and adherence.

Outcome: Symptom improvement will be compared between the two study arms at different times using

• The Pediatric Anxiety Rating Scale (PARS)

• The Clinical Global Impression of Improvement Scale (CGI-I)

• The Children's Global Assessment Scale (CGAS)

• The Screen for Child Anxiety Related Disorders (SCARED)

• The State-Trait Anxiety Inventory for Children (STAI-C)

• The Self-Efficacy Questionnaire (SEQ-C)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

INCLUSION CRITERIA:

-ALL JUVENILE SUBJECTS WITH AN ANXIETY DISORDER:

• Diagnosis: Current Diagnosis of Social Phobia, Separation Anxiety, Generalized Anxiety Disorder, or Panic Disorder (Based on K-SADS (juveniles))

• Symptom Severity: Clinically significant, ongoing anxiety symptoms

• Clinical Impairment: Clinically significant, ongoing distress or impairment from anxiety

• Age: 8 - 17 (subjects who consent as 17- year-olds but turn 18 during the course of the study will be eligible to complete all procedures completed by other subjects who consent as 17- year- old but do not turn 18).

• Consent: can give consent/assent (Parents will provide consent; minors will provide assent)

• IQ: all subjects will have intelligence quotient (IQ) > 70 (Assessment relies on WASI)

• Language: all subjects will speak English

EXCLUSION CRITERIA:

• Any serious medical condition or condition that interferes with participation

• Pregnancy

• Current use of any psychoactive substance; current suicidal ideation; current diagnosis of attention deficit hyperactivity disorder (ADHD) of sufficient severity to require pharmacotherapy.

• Current diagnoses Tourette's Disorder, obsessive compulsive disorder (OCD), post-traumatic distress disorder, conduct disorder

• Past or current history of mania, psychosis, or severe pervasive developmental disorder

• Recent use of an selective serotonin reuptake inhibitor (SSRI); all subjects must have been free of any SSRI-use for at least one month (fluoxetine six months) and must not have been treated with an SSRI for their current depressive episode.

• National Institute of Mental Health (NIMH) employees and staff and their immediate family members will be excluded from the study per NIMH policy

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• Active Attention Bias Modification Training
Computer-based attention bias modification training administered at weekly CBT session aimed at re-training attentional biases
• Placebo Attention Bias Modification Training

Locations

Country	Name	City	State
United States	NIH Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Britton JC, Suway JG, Clementi MA, Fox NA, Pine DS, Bar-Haim Y. Neural changes with attention bias modification for anxiety: a randomized trial. Soc Cogn Affect Neurosci. 2015 Jul;10(7):913-20. doi: 10.1093/scan/nsu141. Epub 2014 Oct 24. — View Citation

Linke JO, Jones E, Pagliaccio D, Swetlitz C, Lewis KM, Silverman WK, Bar-Haim Y, Pine DS, Brotman MA. Efficacy and mechanisms underlying a gamified attention bias modification training in anxious youth: protocol for a randomized controlled trial. BMC Psychiatry. 2019 Aug 7;19(1):246. doi: 10.1186/s12888-019-2224-2. — View Citation

White LK, Sequeira S, Britton JC, Brotman MA, Gold AL, Berman E, Towbin K, Abend R, Fox NA, Bar-Haim Y, Leibenluft E, Pine DS. Complementary Features of Attention Bias Modification Therapy and Cognitive-Behavioral Therapy in Pediatric Anxiety Disorders. Am J Psychiatry. 2017 Aug 1;174(8):775-784. doi: 10.1176/appi.ajp.2017.16070847. Epub 2017 Apr 14. Erratum In: Am J Psychiatry. 2018 Jan 1;175(1):83. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pediatric Anxiety Rating Scale	The Pediatric Anxiety Rating Scale (PARS) measures anxiety symptoms and related functional impairment in youth as continuous outcome. It comprises a 50- item checklist asking for seven dimensions of global severity/ impairment: Each item is rated on a 0- 5 scale by a clinician based on parent- and child-report. The sum score is calculated based on 5 of the 7 sub-scales and ranges from 0 to 25 with higher scores reflecting greater levels of anxiety. PARS score was measured at different time points during the study.	Weeks 3, 8, and 12
Primary	Clinical Global Impression of Improvement Scale	The Clinical Global Impression of Improvement (CGI-I) scale is a measure of global symptom improvement rated by clinicians. Scores range from 1-7, with lower scores reflecting greater levels of improvement. This scale provides an ordinal outcome, as participants with CGI-I ratings less than or equal to 3 at week 8 are considered "responders" and participants with scores >3 at week 8 are considered "non-responders".	Week 8
Secondary	Children's Global Assessment Scale	The Children's Global Assessment Scale (CGAS) is a clinician-rated measure of global functioning, with scores ranging from 1 to 100. Higher score indicates better overall functioning.	Weeks 3, 8, and 12
Secondary	Screen for Child Anxiety Related Disorders	The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item, dual-informant measure of pediatric anxiety symptoms; we use the mean of the parent and child ratings. The questionnaire consists of five subscales assessing symptoms of generalized anxiety, social anxiety, separation anxiety, panic, and school refusal. Items are rated on a scale from 0 to 2; the overall score range is 0 to 82. Higher scores reflect greater levels of anxiety.	Weeks 3, 8, and 12
Secondary	State-Trait Anxiety Inventory for Children	The level of anxiety was assessed using the State-Trait Anxiety Inventory for Children (STAI-C). STAI-C is a 20-item self-report measure of trait anxiety. Items are rated on a scale from 1 to 3; the overall score range is 20-60. Higher scores reflect greater levels of anxiety. STAI-C score was measured at different time points during the study.	Weeks 3, 8, and 12
Secondary	Self-Efficacy Questionnaire	The Self-Efficacy Questionnaire (SEQ-C) is a 24-item self-report measure of self-efficacy in youth. The questionnaire is made up of three subscales assessing social self-efficacy, academic self-efficacy, and emotional self-efficacy. Items are rated on a scale from 1 to 5; the overall score range is 24-120. Higher scores reflect higher levels of self-efficacy.	Pre-Treatment Screening, Weeks 3, and 12