An interventional study of Active Attention Bias Modification Training and Placebo Attention Bias Modification Training in Anxiety Disorders, sponsored by National Institutes of Health Clinical Center (CC). Completed at 1 site in United States. Open to participants aged 8 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by National Institutes of Health Clinical Center (CC) · Not applicable, Interventional, and Treatment
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,
Outcome: Symptom improvement will be compared between the two study arms.
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,
Outcome: Symptom improvement will be compared between the two study arms at different times using
-ALL JUVENILE SUBJECTS WITH AN ANXIETY DISORDER:
EXCLUSION CRITERIA:
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.
Behavioral: Active Attention Bias Modification Training
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.
Behavioral: Placebo Attention Bias Modification Training
Computer-based attention bias modification training administered at weekly CBT session aimed at re-training attentional biases
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.
Time frame: Weeks 3, 8, and 12
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
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.
Time frame: Weeks 3, 8, and 12
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.
Time frame: Weeks 3, 8, and 12
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.
Time frame: Weeks 3, 8, and 12
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.
Time frame: Pre-Treatment Screening, Weeks 3, and 12
| Milestone | Active Intervention | Control Intervention |
|---|---|---|
| Started | 59 | 62 |
| Completed | 48 | 49 |
| Not completed | 11 | 13 |
| Withdrew: Scheduling conflict | 8 | 10 |
| Withdrew: Due to coronavirus disease 2019 (covid-19) pandemic | 1 | 1 |
| Withdrew: Technical software issue | 2 | 2 |
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.
| units on a scale | Active Intervention | Control Intervention |
|---|---|---|
| Week 3 | 13.596491 ± 0.5472 | 14.557377 ± 0.4867 |
| Week 8 | 11.50 ± 0.5500 | 12.206897 ± 0.5146 |
| Week 12 | 9.666667 ± 0.66431 | 9.890909 ± 0.5564 |
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".
| participants | Active Intervention | Control Intervention |
|---|---|---|
| Responders | 11 | 16 |
| Non-Responders | 39 | 41 |
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.
| units on a scale | Active Intervention | Control Intervention |
|---|---|---|
| Week 3 | 54.38596 ± 0.9155282 | 54.38596 ± 0.9748576 |
| Week 8 | 61.03704 ± 0.9076748 | 59.75000 ± 0.8083372 |
| Week 12 | 65.58182 ± 1.2581561 | 67.42105 ± 1.3020967 |
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.
| units on a scale | Active Intervention | Control Intervention |
|---|---|---|
| Week 3 | 30.08051 ± 1.288642 | 30.28443 ± 1.579966 |
| Week 8 | 26.29412 ± 1.402873 | 28.40000 ± 1.504715 |
| Week 12 | 24.49434 ± 1.381877 | 25.71429 ± 1.592165 |
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.
| units on a scale | Active Intervention | Control Intervention |
|---|---|---|
| Week 3 | 39.58929 ± 1.029997 | 38.64407 ± 1.222658 |
| Week 8 | 38.94340 ± 1.090404 | 38.35484 ± 1.089612 |
| Week 12 | 36.92857 ± 1.011254 | 36.55357 ± 1.162431 |
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.
| units on a scale | Active Intervention | Control Intervention |
|---|---|---|
| Pre-Treatment | 69.65 ± 2.116646 | 77.61538 ± 2.124853 |
| Week 3 | 71.76364 ± 1.770876 | 75.21429 ± 2.024158 |
| Week 12 | 77.57143 ± 1.897342 | 78.07407 ± 1.964011 |
Collected over Up to 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Intervention | 0/59 (0%) | 3/59 (5.1%) | 7/59 (11.9%) |
| Control Intervention | 0/62 (0%) | 1/62 (1.6%) | 7/62 (11.3%) |
| Event | Active Intervention | Control Intervention |
|---|---|---|
| Suicidal ideationPsychiatric disorders | 3/59 | 0/62 |
| Intentional self-injuryPsychiatric disorders | 1/59 | 0/62 |
| Self-injurious ideationPsychiatric disorders | 0/59 | 1/62 |
| Event | Active Intervention | Control Intervention |
|---|---|---|
| HeadacheNervous system disorders | 4/59 | 3/62 |
| NauseaGastrointestinal disorders | 2/59 | 1/62 |
| DyspepsiaGastrointestinal disorders | 1/59 | 0/62 |
| FatigueGeneral disorders | 1/59 | 1/62 |
| Blunted affectPsychiatric disorders | 1/59 | 1/62 |
| InsomniaPsychiatric disorders | 1/59 | 0/62 |
| IrritabilityPsychiatric disorders | 1/59 | 0/62 |
| Suicidal behaviourPsychiatric disorders | 1/59 | 0/62 |
| ConcussionNervous system disorders | 0/59 | 1/62 |
| SedationNervous system disorders | 0/59 | 1/62 |
| Age, Categorical(Participants) | Active Intervention | Control Intervention | Total |
|---|---|---|---|
| <=18 years | 59 | 62 | 121 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Active Intervention | Control Intervention | Total |
|---|---|---|---|
| Female | 36 | 37 | 73 |
| Male | 23 | 25 | 48 |
| Ethnicity (NIH/OMB)(Participants) | Active Intervention | Control Intervention | Total |
|---|---|---|---|
| Hispanic or Latino | 9 | 8 | 17 |
| Not Hispanic or Latino | 47 | 54 | 101 |
| Unknown or Not Reported | 3 | 0 | 3 |
| Race (NIH/OMB)(Participants) | Active Intervention | Control Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 4 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 4 |
| White | 41 | 46 | 87 |
| More than one race | 11 | 10 | 21 |
| Unknown or Not Reported | 2 | 1 | 3 |
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National Institutes of Health Clinical Center (CC)