Clinical trial NCT03283930: A Clinical Trial of a Gamified Attention Bias Modification Training in Anxious Youth
Official title: A Clinical Trial of a Gamified Attention Bias Modification Training in Anxious Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Keywords: Cognitive Behavioral Therapy (CBT)
Attention
Anxiety
Children
Adolescents
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2017-09-14
Enrollment: 121
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with anxiety disorders are assessed on a number of mental health and biological variables. Patients who can agree to attend regular psychotherapy sessions are randomized to receive cognitive behavioral therapy with computer-based augmentation. In one study arm, these patients receive cognitive behavioral therapy with an active form of a computer game. In the other treatment arm, subjects receive cognitive behavioral therapy with a control treatment.
Primary purpose: TREATMENT

Brief 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.

Detailed 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)

Eligibility criteria: 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

Primary outcomes:
measure: Pediatric Anxiety Rating Scale
timeFrame: Weeks 3, 8, and 12
measure: Clinical Global Impression of Improvement Scale
timeFrame: Week 8
Secondary outcomes:
measure: Children's Global Assessment Scale
timeFrame: Weeks 3, 8, and 12
measure: Screen for Child Anxiety Related Disorders
timeFrame: Weeks 3, 8, and 12
measure: State-Trait Anxiety Inventory for Children
timeFrame: Weeks 3, 8, and 12
measure: Self-Efficacy Questionnaire
timeFrame: Pre-Treatment Screening, Weeks 3, and 12
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: NIH Clinical Center
state: Maryland
Study officials:
affiliation: National Institute of Mental Health (NIMH)
name: Daniel Pine, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
citation: Lewis KM, Matsumoto C, Cardinale E, Jones EL, Gold AL, Stringaris A, Leibenluft E, Pine DS, Brotman MA. Self-Efficacy As a Target for Neuroscience Research on Moderators of Treatment Outcomes in Pediatric Anxiety. J Child Adolesc Psychopharmacol. 2020 May;30(4):205-214. doi: 10.1089/cap.2019.0130. Epub 2020 Mar 11.