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CBT and the Neural Circuits of Anxiety

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…

ClinicalTrials.gov IDNCT05549102

PhaseNot Applicable

Enrollment174

SponsorUCLH/UCL Joint Research Office

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

Interventions

Behavioral: Cognitive Behavioural Therapy — In the Cognitive Behavioural Therapy group (N=87), patients will undergo CBT as part of their routine care in Step 3 of the IAPT programme. This will be administered by suitably trained clinicians. The specification of CBT is as recommended by the National Institute for Health and Care Excellence (NICE) guidelines (CG113 - Generalised anxiety disorder and panic disorder in adults: management). In these guidelines, patients are offered on average, 12-15 hourly, weekly sessions of CBT with a trained and competent practitioners. Therapy sessions involve discussions that identify patterns in thinking or behaviours which may be problematic, and therapists and patients work to set goals to reduce these using cognitive techniques. The principle is to teach the patient how to use CBT techniques in their day-to-day life to promote a lasting effect on mental health. We will test patients before (T1) and after (T2) a course of treatment.
Other: Waiting List — In the control group (N=87), we will test patients who are currently seeking (but not undergoing) treatment before (T1) and after a wait (T2) of equivalent time (i.e. waiting list controls)

Primary outcomes

'Aversive amplification circuit' connectivity (Day 0, up to 12 weeks (post-CBT or matched time on waiting list))

Eligibility information

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

Study locations

Institute of Cognitive Neuroscience, University College London, London, WC1N 3AZ United Kingdom

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.