Anxiety Clinical Trial - CBT & the Neural Circuits of Anxiety

Status Recruiting

Clinical Trial Summary

This study will aim to test whether specific neural circuitry changes, proposed on the basis of a neurocognitive model of anxiety, are a mechanism of action for Cognitive Behavioural Therapy (CBT) interventions. This study aims to provide a theoretical model of the neurobiological mechanisms of CBT's therapeutic effect, where there currently is none, and potentially allow for more targeted/specific approaches to anxiety disorders following the identification of key CBT mechanisms. The ultimate aim is to improve the efficacy of CBT, and more generally, psychological interventions for anxiety disorders.

Clinical Trial Description

To test the hypothesis that the neural circuitry of the amygdala and prefrontal cortex will respond to CBT, the impact of a course of CBT on cortical-subcortical circuitry will be tested via a case-control study in individuals entering Improving Access to Psychological Therapies (IAPT) services (IAPT step 3; i.e., full CBT) for anxiety disorders and individuals in waiting lists. This design leverages the naturalistic waiting times in the clinical service and does not interfere with treatment as usual. Measures of brain region-specific connectivity and emotion-related behavioural performance will be assessed through testing sessions at the University College London (UCL) Institute of Cognitive Neuroscience and the Birkbeck-UCL Centre for NeuroImaging (BUCNI), involving computerised cognitive/psychological tasks and functional magnetic resonance imaging (fMRI). The aims are to: 1. test whether this circuit responds to a course of CBT, by demonstrating disengagement of the circuit following CBT 2. relate this change in circuit function to behaviour through cognitive measures of emotional processing 3. explore the neurobiological features that distinguish patients who respond to CBT and those who do not 4. compare the data from this study to another on-going study assessing the impact of pharmacological interventions for anxiety, allowing for the comparison of neurobiological mechanisms of psychological vs. pharmacological treatments in anxiety. ;

Study Design

Related Conditions & MeSH terms

Anxiety
Anxiety Depression
Anxiety Disorder Generalized
Anxiety Disorder; Mixed With Depression (Mild)
Anxiety Disorders
Anxiety Disorders and Symptoms
Anxiety Generalized
CBT
Depression
Depressive Disorder
Disease
Generalised Anxiety Disorder

Clinical Trial Details

NCT number	NCT05549102
Study type	Observational
Source	UCLH/UCL Joint Research Office
Contact	Millie Lowther
Phone	02039872331
Email	millie.lowther@ucl.ac.uk
Status	Recruiting
Phase
Start date	February 2, 2020
Completion date	August 1, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

CBT and the Neural Circuits of Anxiety

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms