CBT and the Neural Circuits of Anxiety

NCT05549102 | Recruiting

• 2 other identifiers: 121261255501
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

GAD; generalised anxiety disorder; anxiety disorders; cognitive behavioural therapy; CBT; psychological therapy; neural circuitry; emotional processing

Outcome Measures

Primary Outcomes (1)

• 'Aversive amplification circuit' connectivity

  The engagement of the neural circuit of the amygdala, cingulate cortex and prefrontal cortex will be measured via an fMRI analysis technique called a psychophysiological interactions (PPI) analysis. PPI analysis concerns behaviour-specific increases in the relationship across regional brain activity - this means that it can allow one to assess whether two regions (a priori selected ROIs) show increased connectivity during a specific context or behaviour, suggesting a behaviour-specific increase in transfer of information. The output of this analysis will take form of a continuous beta weight - an index of connectivity across two brain regions (amygdala and medial prefrontal cortex), which represents the primary outcome of the study.

  Day 0, up to 12 weeks (post-CBT or matched time on waiting list)

Secondary Outcomes (16)

• Cognitive task performance: Loss/risk aversion task

  Day 0, up to 12 weeks (post-CBT or matched time on waiting list)

• Cognitive task performance: Go/no-go task

  Day 0, up to 12 weeks (post-CBT or matched time on waiting list)

• Cognitive task performance: Facial emotional processing task

  Day 0, up to 12 weeks (post-CBT or matched time on waiting list)

• Cognitive task performance: Emotional face recognition task

  Day 0, up to 12 weeks (post-CBT or matched time on waiting list)

• Cognitive task performance: Visual affective bias task

  Day 0, up to 12 weeks (post-CBT or matched time on waiting list)

Other Outcomes (1)

• Mood diary

  Day 0, up to 12 weeks (post-CBT or matched time on waiting list)

Study Arms (2)

Treatment Group

Participants undergoing a course of Cognitive Behavioural Therapy (CBT)

Behavioral: Cognitive Behavioural Therapy

Waiting List Group

Participants on the Waiting List for CBT

Other: Waiting List

Interventions

Cognitive Behavioural Therapy BEHAVIORAL

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.

Also known as: CBT

Treatment Group

Waiting List OTHER

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)

Waiting List Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Individuals entering IAPT services (IAPT step 3; i.e., full CBT) for anxiety disorders

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCLH/UCL Joint Research Office: lead
• Medical Research Council: collaborator
• Camden and Islington NHS Trust: collaborator
• Central and North West London NHS Foundation Trust: collaborator

Study Sites (1)

Institute of Cognitive Neuroscience, University College London

London, WC1N 3AZ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders; Lymphoma, Follicular

Interventions

Cognitive Behavioral Therapy; Waiting Lists

Condition Hierarchy (Ancestors)

Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Appointments and Schedules; Organization and Administration; Health Services Administration

Central Study Contacts

Emily Lewis

CONTACT

02039872331; emily.lewis.23@ucl.ac.uk

Oliver Robinson

CONTACT

02076791150; o.robinson@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 22, 2022
• Study Start: February 2, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

GB (1)