Dimensional Brain Behavior Predictors of CBT Outcomes in Pediatric Anxiety (Anxiety-CBT)
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|ClinicalTrials.gov Identifier: NCT02810171|
Recruitment Status : Recruiting
First Posted : June 22, 2016
Last Update Posted : April 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Disorders Social Anxiety Disorder Social Phobia Generalized Anxiety Disorder Separation Anxiety Disorder Specific Phobia Phobia Agoraphobia Panic Disorder Panic Attack Anxiety||Behavioral: Cognitive Behavioral Therapy Behavioral: Relaxation Therapy||Not Applicable|
4.3.20 Update: Recruitment is ongoing. Enrollment is temporarily paused due to COVID-19. Current participants remain active remotely. This is not a suspension of IRB approval.
Impairing anxiety affects 33% of the population by adolescence and can become chronic, leading to depression, substance abuse, school-drop out and even suicide. To reduce anxiety and prevent its sequelae, patients must be effectively treated early; yet, the first line intervention, cognitive behavioral therapy (CBT), has a heterogeneous response with 40-60% of treated patients continuing to experience impairment from residual symptoms. The reasons for variability in CBT outcomes remain poorly understood, but individual (including developmental) differences in brain-behavioral targets of CBT may contribute. This proposal addresses two primary questions: 1) Do individual differences in CBT-relevant brain-behavioral functions lead to variation in CBT outcomes? and 2) Does development contribute to this variation? To answer these questions, this study will measure changes in brain and behavior markers of anxiety, before and after CBT, in children and adolescents across traditional, categorical anxiety disorders (e.g., social, generalized and separation anxiety disorders). Given that CBT facilitates control over fear to enable effective regulation, the investigators hypothesize that brain-behavioral markers of fear sensitivity, cognitive regulatory capacity and cognitive regulation of fear will predict and characterize mechanisms of CBT effect. In addition, the investigators hypothesize that these markers will differentially relate to CBT effect, depending on patient age.
Children and adolescents (7.0 - 17.99 years) with clinically impairing anxiety will be randomized to receive CBT or a relaxation control therapy for 12 weeks. Before and after therapy, all participants will receive an MRI scan to see what regions of the brain become active when emotion and concentration tasks are performed and how that activation is changed after CBT.
While the study itself is of parallel design for its data-collection and measurement purpose, it is listed as a partial-crossover design in the IRB-approved protocol because subjects randomized to the relaxation therapy are given the option of receiving 12-weeks of CBT sessions after the relaxation therapy data has been collected. Some limited data will be collected in patients who are initially randomized to relaxation therapy but then opt to crossover to CBT. MRI data will also be collected in healthy youth before and after 12 weeks (but without intervening therapy) to allow the investigators to control for the simple effects of time that may cause brain changes that are not related to therapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Dimensional Brain Behavior Predictors of CBT Outcomes in Pediatric Anxiety|
|Actual Study Start Date :||December 2016|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
|Active Comparator: Cognitive Behavioral Therapy||
Behavioral: Cognitive Behavioral Therapy
A therapy which teaches patients coping skills to manage anxiety and gradually yet repeatedly exposes patients to anxiety-provoking thoughts and situations until the anxiety habituates/diminishes.
Other Name: CBT
Behavioral: Relaxation Therapy
An active control therapy with minimal effects on anxiety symptoms. If randomized to this therapy, participants will have the option to cross-over to CBT once the relaxation therapy arms has been completed.
No Intervention: No Intervention: Healthy youth only
Healthy control participants, matched to gender and age with anxiety patients, will be enrolled. These healthy participants will be scanned with fMRI before and after ~16 weeks, but without any intervention (i.e., no therapy).
- Brain function/structure as assessed by Magnetic Resonance Imaging scans [ Time Frame: Baseline and 12-weeks ]Pre- to post-CBT changes in functional, connectivity and structural MRI measures of brain networks relevant for anxiety. Brain regions include the amygdala, anterior insula, dorsal anterior cingulate cortex (dACC) and ventrolateral prefrontal cortex (vlPFC). Functional activation and connectivity of these brain regions are assessed using simple computer tasks performed during MRI scanning. Tasks engage threat reactivity, self-regulatory control and the interaction of these processes. Structural connections between regions will be measured using a MRI technique that measures water diffusion in the brain.
- Pediatric Anxiety Rating Scale [ Time Frame: weeks 0, 3, 6, 9, 12 ]The Pediatric Anxiety Rating Scale (PARS) is a clinician-administered assessment to rate the severity of anxiety symptoms associated with common DSM-V anxiety disorders (social phobia, separation anxiety disorder, and generalized anxiety disorder) in children. The investigators are looking for decreases in anxiety severity ratings from pre- to post-treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810171
|Contact: Jennifer Nidetz, M.S.Wfirstname.lastname@example.org|
|Contact: Riley Loweemail@example.com|
|Principal Investigator:||Kate D. Fitzgerald, M.D.||University of Michigan|