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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03283930

Enrollment

121

Registered

2017-09-14

Start date

2016-11-01

Completion date

2023-09-01

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders

Keywords

Cognitive Behavioral Therapy (CBT), Attention, Anxiety, Children, Adolescents

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)

Interventions

BEHAVIORALActive Attention Bias Modification Training

Computer-based attention bias modification training administered at weekly CBT session aimed at re-training attentional biases

BEHAVIORALPlacebo Attention Bias Modification Training

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

The active and control treatment arms differ in the spatial arrangements of figures on a computer screen. Because these figures are presented for very brief periods of time, subjects cannot easily decipher differences in the arrangements across the active and control treatments. All study team members who work with patients remain blind to the treatment conditions as well.

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.

Eligibility

Sex/Gender

ALL

Age

8 Years to 17 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pediatric Anxiety Rating Scale	Weeks 3, 8, and 12	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.
Clinical Global Impression of Improvement Scale	Week 8	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.

Secondary

Measure	Time frame	Description
Children's Global Assessment Scale	Weeks 3, 8, and 12	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.
Screen for Child Anxiety Related Disorders	Weeks 3, 8, and 12	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.
State-Trait Anxiety Inventory for Children	Weeks 3, 8, and 12	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.
Self-Efficacy Questionnaire	Pre-Treatment Screening, Weeks 3, and 12	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Active Intervention Children and adolescent participants with anxiety disorder receive cognitive behavioral therapy (CBT) for a 12-week period. In the final eight weeks of the trial, the subjects complete the Active Attention Bias Modification Training (ABMT), computer-based attention bias modification training aimed at re-training attentional biases before a CBT session: Part 1. modified dot-probe task, where a target is always presented at the previous location of the neutral and not the simultaneously presented threatening stimulus. Part 2. visual search, where the targets are always presented distally of threatening distractors.	59
Control Intervention Children and adolescent participants with anxiety disorder receive cognitive behavioral therapy (CBT) for a 12-week period. In the final eight weeks of the trial, the subjects complete the control intervention before a CBT session: Part 1. dot-probe task, where a target is equally randomly presented at the previous location of the neutral or the simultaneously presented threatening stimulus. Part 2. visual search, where the targets are equally randomly presented distal of neutral and threatening distractors.	62
Total	121

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Due to coronavirus disease 2019 (COVID-19) pandemic	1	1
Overall Study	Scheduling conflict	8	10
Overall Study	Technical software issue	2	2

Baseline characteristics

Characteristic	Active Intervention	Control Intervention	Total
Age, Categorical <=18 years	59 Participants	62 Participants	121 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants	8 Participants	17 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants	54 Participants	101 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants	0 Participants	3 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Asian	1 Participants	4 Participants	5 Participants
Race (NIH/OMB) Black or African American	3 Participants	1 Participants	4 Participants
Race (NIH/OMB) More than one race	11 Participants	10 Participants	21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	1 Participants	3 Participants
Race (NIH/OMB) White	41 Participants	46 Participants	87 Participants
Sex: Female, Male Female	36 Participants	37 Participants	73 Participants
Sex: Female, Male Male	23 Participants	25 Participants	48 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 59	0 / 62
other Total, other adverse events	7 / 59	7 / 62
serious Total, serious adverse events	3 / 59	1 / 62

Outcome results

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.

Time frame: Week 8