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Attention Bias Modification Training / Cognitive Behavioral Therapy / Anxiety Disorders · Phase 2 Trial
ClinicalTrials.gov · August 7, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 mechanistic trial registering an intention to enroll 3500 pediatric patients with anxiety disorders and healthy comparisons to examine neural biomarkers of anxiety and their relationship to treatment response with cognitive behavioral therapy or fluoxetine over one year. No results have been posted in this registry record, and the study remains in recruitment; the evidence base is therefore limited to the study design and planned endpoints only.
Phase 2, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Anxiety Disorders, Major Depressive Disorder; age from 8 Years; to 65 Years; accepts healthy volunteers. Intervention: Active. Compared with: Control — Placebo Comparator. n = 3,500. 2 sites: United States.
This is a Phase 2 mechanistic trial registering an intention to enroll 3500 pediatric patients with anxiety disorders and healthy comparisons to examine neural biomarkers of anxiety and their relationship to treatment response with cognitive behavioral therapy or fluoxetine over one year. No results have been posted in this registry record, and the study remains in recruitment; the evidence base is therefore limited to the study design and planned endpoints only.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
No clinical impact can be assessed because this trial has not yet reported results. Clinicians should monitor for outcomes related to neuro-cognitive predictors of CBT and fluoxetine response in pediatric anxiety, pending publication.
This is a Phase 2 interventional trial still recruiting, with no results reported; it is designed to examine neuro-cognitive correlates and treatment response in pediatric anxiety but cannot yet support clinical or practice conclusions.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be assessed because this trial has not yet reported results. Clinicians should monitor for outcomes related to neuro-cognitive predictors of CBT and fluoxetine response in pediatric anxiety, pending publication.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT00018057). This is a study registration, not published results. Lead sponsor: National Institute of Mental Health (NIMH). Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 3500 participants (ESTIMATED). Conditions: Anxiety Disorders, Major Depressive Disorder. Interventions: BEHAVIORAL: Attention Bias Modification Training; DRUG: Fluoxetine; BEHAVIORAL: Cognitive Behavioral Therapy. Primary outcome measures: Pediatric Anxiety Rating Scale (PARS) , Weekly; Clinical Global Improvement (CGI) Scale , Weekly. Brief summary: Study Description: This study examines relations between neurocognitive and clinical features of pediatric anxiety disorders. The study uses neuro-cognitive tasks, functional magnetic resonance imaging (fMRI), as well as magneto- and electro-encephalography (M/EEG). Patients will be studied over one year, before and after receiving either one of two standard-of-care treatments: cognitive behavioral therapy (CBT) or fluoxetine, a serotonin reuptake inhibitor (SSRI). Healthy comparisons will be studied at comparable time points. Primary Objectives: To compare healthy youth and symptomatic, medication-free pediatric patients studied prior to receipt of treatment. The study seeks to detect relations between clinical features of anxiety disorders at baseline and a wide range of neurocognitive features associated with attention, memory, and response to motivational stimuli. Secondary Objectives: 1. To document relations between baseline neurocognitive features and response to Cognitive Behavioral Therapy (CBT) or fluoxetine, as defined by the Pediatric Anxiety Rating Scale (PARS) and Clinical Global Improvement (CGI) Scale. 2. To document relations between post-treatment changes in neurocognitive features and anxiety symptoms on the PARS following treatment with Cognitive Behavioral Therapy (CBT) or fluoxetine. 3. To document relations among broad arrays of clinical, cognitive, and neural measures Primary Endpoints: Indices of percent-signal change in hypothesized brain regions, comprising amygdala, striatum, and prefrontal cortex (PFC) for each fMRI and MEG paradigm. Secondary Endpoints: 1. Treatment-response as defined by a continuous measure, the Pediatric Anxiety Rating Scale score (PARS), and a categorial measure, the Clinical Global Improvement (CGI) score. 2. Levels of symptoms and behaviors evoked by tasks that engage attention, memory, and elicit responses to motivational stimuli. ...
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