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
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Among 2,269 studies in Anxiety Disorders with a site in United States — 398 open to participants now, 503 under way, 13 of them phase 3. Anxiety Disorders · United States.
Among the 2,269 studies in Anxiety Disorders with a site in United States, this one is the 635th largest by enrollment of the 2,045 interventional ones that give a count, is one of 90 that started in 2016, is one of 1,609 with no phase, and was the 825th registered.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
Browse Anxiety Disorders studies →398 of the 2,269 studies in Anxiety Disorders with a site in United States are open now. Recruiting first, the newest first:
University of Wisconsin, Madison · Sites in United States
Ages 18+
Children's Mercy Hospital Kansas City · Sites in United States
Ages 13–17
Columbia University · Sites in United States
Ages 12–21
Ohio State University · Sites in United States
Ages 21–65
Ohio State University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 944 Anxiety Disorders studies recruiting now, 417 (44%) set no upper age limit and 460 (49%) stop at 75 or younger; 233 take children under 18; 317 take healthy volunteers.
This study: 8 Years to 17 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
2,269 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 119 · Phase 2 201 · Phase 3 95 · Phase 4 88
First in 1983; this study’s year is marked. 90 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 121 is above the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Median enrollment 68 across the 2,045 interventional studies, 156 across the 215 observational. Of the 1,599 that completed or were terminated, 503 (31%) have results posted.
This tab as a report to print or save as PDF → With an account.
185 of 2,269 have an industry lead sponsor. The 10 most frequent:
National Institutes of Health Clinical Center (CC) is the lead sponsor of 376 studies on the registry; 27 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.
National Institutes of Health Clinical Center (CC) has 2 studies filed under Anxiety Disorders — fewer than ten, so there is no comparison to draw.
218 of the studies in Anxiety Disorders with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05552053Phase 3Cedars-Sinai Medical CenterResources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women | 2026-12-31 |
| NCT05474846Phase 3M.D. Anderson Cancer CenterCombination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer | 2027-02-28 |
| NCT06273527Phase 3University of California, San DiegoEnhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol (R33) | 2027-06-01 |
| NCT07123467Phase 3Wayne State UniversityCannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder | 2027-08-31 |
| NCT07718646Oklahoma State UniversityMobile Health Coping Intervention for Mothers Experiencing Food Insecurity | 2026-11 |
Add all 218 to your calendar (.ics) → With an account.
Among the 2,269 studies in Anxiety Disorders with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
-ALL JUVENILE SUBJECTS WITH AN ANXIETY DISORDER:
EXCLUSION CRITERIA:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2016 to primary completion in Sep 2023, 82 months.
Results were first posted in Apr 2024, 7 months after primary completion.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 82 months is above that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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