CBT and the Neural Circuits of Anxiety

UCLH/UCL Joint Research Office

Status: Enrolling

Conditions: Anxiety Disorders and Symptoms; Anxiety Disorder Generalized; Anxiety Depression; CBT; Anxiety Disorder; Mixed With Depression (Mild); Generalised Anxiety Disorder; Anxiety; Anxiety Disorders; Anxiety Generalized

Treatments: Other: Waiting List; Behavioral: Cognitive Behavioural Therapy

Study type: Observational

Funder types: Other

Identifiers

NCT05549102

121261

255501 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 174 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Enrolled in IAPT Step 3 (high intensity service)
• Score of or above 8 on the GAD-7 (indicating moderate anxiety on a standard scale of anxiety; Spitzer et al., 2006)
• Willing and able to provide written consent

Exclusion criteria

• Score above 22 on the GAD-7
• Past/present psychotic disorder, bipolar disorder/mania or alcohol/substance use disorder (outside a comorbid psychiatric episode)
• History of medical illness that may impair cognitive function (e.g. serious head injury, endocrine disorder)
• Current psychotropic pharmacological intervention (e.g. SSRIs) or use within 3 months
• MRI contraindications such as pacemaker, aneurysm clip, cochlear implant, neurostimulator, IUD, shrapnel, metal fragments in eye, weight of above 250lbs or claustrophobia
• Females who are pregnant, planning pregnancy, or breastfeeding

Trial design

174 participants in 2 patient groups

Treatment Group

Description:

Participants undergoing a course of Cognitive Behavioural Therapy (CBT)

Treatment:

Behavioral: Cognitive Behavioural Therapy

Waiting List Group

Description:

Participants on the Waiting List for CBT

Treatment:

Other: Waiting List