Trial Outcomes & Findings for A Clinical Trial of a Gamified Attention Bias Modification Training in Anxious Youth (NCT NCT03283930)
NCT ID: NCT03283930
Last Updated: 2024-04-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
121 participants
Primary outcome timeframe
Weeks 3, 8, and 12
Results posted on
2024-04-09
Participant Flow
Participant milestones
| Measure |
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.
|
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.
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|---|---|---|
|
Overall Study
STARTED
|
59
|
62
|
|
Overall Study
COMPLETED
|
48
|
49
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
Reasons for withdrawal
| Measure |
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.
|
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.
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|---|---|---|
|
Overall Study
Scheduling conflict
|
8
|
10
|
|
Overall Study
Due to coronavirus disease 2019 (COVID-19) pandemic
|
1
|
1
|
|
Overall Study
Technical software issue
|
2
|
2
|
Baseline Characteristics
A Clinical Trial of a Gamified Attention Bias Modification Training in Anxious Youth
Baseline characteristics by cohort
| Measure |
Active Intervention
n=59 Participants
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.
|
Control Intervention
n=62 Participants
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.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
59 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 3, 8, and 12Population: The analyses included participants who were randomized to either arm of the study and had data available for analysis.
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.
Outcome measures
| Measure |
Active Intervention
n=57 Participants
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.
|
Control Intervention
n=61 Participants
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.
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|---|---|---|
|
Pediatric Anxiety Rating Scale
Week 8
|
11.50 units on a scale
Standard Error 0.5500
|
12.206897 units on a scale
Standard Error 0.5146
|
|
Pediatric Anxiety Rating Scale
Week 12
|
9.666667 units on a scale
Standard Error 0.66431
|
9.890909 units on a scale
Standard Error 0.5564
|
|
Pediatric Anxiety Rating Scale
Week 3
|
13.596491 units on a scale
Standard Error 0.5472
|
14.557377 units on a scale
Standard Error 0.4867
|
PRIMARY outcome
Timeframe: Week 8Population: The analyses included participants who were randomized to either arm of the study and had data available for analysis.
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".
Outcome measures
| Measure |
Active Intervention
n=50 Participants
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.
|
Control Intervention
n=57 Participants
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.
|
|---|---|---|
|
Clinical Global Impression of Improvement Scale
Non-Responders
|
39 participants
|
41 participants
|
|
Clinical Global Impression of Improvement Scale
Responders
|
11 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Weeks 3, 8, and 12Population: The analyses included participants who were randomized to either arm of the study and had data available for analysis.
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.
Outcome measures
| Measure |
Active Intervention
n=57 Participants
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.
|
Control Intervention
n=57 Participants
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.
|
|---|---|---|
|
Children's Global Assessment Scale
Week 3
|
54.38596 units on a scale
Standard Error 0.9155282
|
54.38596 units on a scale
Standard Error 0.9748576
|
|
Children's Global Assessment Scale
Week 12
|
65.58182 units on a scale
Standard Error 1.2581561
|
67.42105 units on a scale
Standard Error 1.3020967
|
|
Children's Global Assessment Scale
Week 8
|
61.03704 units on a scale
Standard Error 0.9076748
|
59.75000 units on a scale
Standard Error 0.8083372
|
SECONDARY outcome
Timeframe: Weeks 3, 8, and 12Population: The analyses included participants who were randomized to either arm of the study and had data available for analysis.
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.
Outcome measures
| Measure |
Active Intervention
n=59 Participants
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.
|
Control Intervention
n=61 Participants
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.
|
|---|---|---|
|
Screen for Child Anxiety Related Disorders
Week 3
|
30.08051 units on a scale
Standard Error 1.288642
|
30.28443 units on a scale
Standard Error 1.579966
|
|
Screen for Child Anxiety Related Disorders
Week 8
|
26.29412 units on a scale
Standard Error 1.402873
|
28.40000 units on a scale
Standard Error 1.504715
|
|
Screen for Child Anxiety Related Disorders
Week 12
|
24.49434 units on a scale
Standard Error 1.381877
|
25.71429 units on a scale
Standard Error 1.592165
|
SECONDARY outcome
Timeframe: Weeks 3, 8, and 12Population: The analyses included participants who were randomized to either arm of the study and had data available for analysis.
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.
Outcome measures
| Measure |
Active Intervention
n=56 Participants
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.
|
Control Intervention
n=62 Participants
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.
|
|---|---|---|
|
State-Trait Anxiety Inventory for Children
Week 3
|
39.58929 units on a scale
Standard Error 1.029997
|
38.64407 units on a scale
Standard Error 1.222658
|
|
State-Trait Anxiety Inventory for Children
Week 8
|
38.94340 units on a scale
Standard Error 1.090404
|
38.35484 units on a scale
Standard Error 1.089612
|
|
State-Trait Anxiety Inventory for Children
Week 12
|
36.92857 units on a scale
Standard Error 1.011254
|
36.55357 units on a scale
Standard Error 1.162431
|
SECONDARY outcome
Timeframe: Pre-Treatment Screening, Weeks 3, and 12Population: The analyses included participants who were randomized to either arm of the study and had data available for analysis.
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.
Outcome measures
| Measure |
Active Intervention
n=56 Participants
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.
|
Control Intervention
n=56 Participants
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.
|
|---|---|---|
|
Self-Efficacy Questionnaire
Pre-Treatment
|
69.65 units on a scale
Standard Error 2.116646
|
77.61538 units on a scale
Standard Error 2.124853
|
|
Self-Efficacy Questionnaire
Week 3
|
71.76364 units on a scale
Standard Error 1.770876
|
75.21429 units on a scale
Standard Error 2.024158
|
|
Self-Efficacy Questionnaire
Week 12
|
77.57143 units on a scale
Standard Error 1.897342
|
78.07407 units on a scale
Standard Error 1.964011
|
Adverse Events
Active Intervention
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Control Intervention
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Intervention
n=59 participants at risk
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.
|
Control Intervention
n=62 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Intentional self-injury
|
1.7%
1/59 • Up to 9 months
|
0.00%
0/62 • Up to 9 months
|
|
Psychiatric disorders
Self-injurious ideation
|
0.00%
0/59 • Up to 9 months
|
1.6%
1/62 • Up to 9 months
|
|
Psychiatric disorders
Suicidal ideation
|
5.1%
3/59 • Up to 9 months
|
0.00%
0/62 • Up to 9 months
|
Other adverse events
| Measure |
Active Intervention
n=59 participants at risk
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.
|
Control Intervention
n=62 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
1/59 • Up to 9 months
|
0.00%
0/62 • Up to 9 months
|
|
Gastrointestinal disorders
Nausea
|
3.4%
2/59 • Up to 9 months
|
1.6%
1/62 • Up to 9 months
|
|
General disorders
Fatigue
|
1.7%
1/59 • Up to 9 months
|
1.6%
1/62 • Up to 9 months
|
|
Nervous system disorders
Concussion
|
0.00%
0/59 • Up to 9 months
|
1.6%
1/62 • Up to 9 months
|
|
Nervous system disorders
Headache
|
6.8%
4/59 • Up to 9 months
|
4.8%
3/62 • Up to 9 months
|
|
Nervous system disorders
Sedation
|
0.00%
0/59 • Up to 9 months
|
1.6%
1/62 • Up to 9 months
|
|
Psychiatric disorders
Blunted affect
|
1.7%
1/59 • Up to 9 months
|
1.6%
1/62 • Up to 9 months
|
|
Psychiatric disorders
Dermatillomania
|
0.00%
0/59 • Up to 9 months
|
1.6%
1/62 • Up to 9 months
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/59 • Up to 9 months
|
1.6%
1/62 • Up to 9 months
|
|
Psychiatric disorders
Insomnia
|
1.7%
1/59 • Up to 9 months
|
0.00%
0/62 • Up to 9 months
|
|
Psychiatric disorders
Irritability
|
1.7%
1/59 • Up to 9 months
|
0.00%
0/62 • Up to 9 months
|
|
Psychiatric disorders
Suicidal behaviour
|
1.7%
1/59 • Up to 9 months
|
0.00%
0/62 • Up to 9 months
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/59 • Up to 9 months
|
1.6%
1/62 • Up to 9 months
|
Additional Information
Dr. Daniel Pine
National Institute of Mental Health (NIMH)
Phone: +1 301 594 1318
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place