CBT and the Neural Circuits of Anxiety

November 14, 2022 updated by: UCLH/UCL Joint Research Office

The Impact of CBT on Shock-Potentiated Neural Circuity

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 Type

Observational

Enrollment (Anticipated)

174

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1N 3AZ
        • Recruiting
        • Institute of Cognitive Neuroscience, University College London
        • Contact:
        • Principal Investigator:
          • Oliver J Robinson, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 62 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment Group
Participants undergoing a course of Cognitive Behavioural Therapy (CBT)
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 Names:
  • CBT
Waiting List Group
Participants on the Waiting List for CBT
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
'Aversive amplification circuit' connectivity
Time Frame: Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive task performance: Loss/risk aversion task
Time Frame: Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Measures how averse participants are to risk and loss in a mock gambling context
Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Cognitive task performance: Go/no-go task
Time Frame: Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Measures approach/avoidance behaviours under threat of shock or safe conditions
Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Cognitive task performance: Facial emotional processing task
Time Frame: Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Measures brain responses to positive, negative and neutral emotions
Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Cognitive task performance: Emotional face recognition task
Time Frame: Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Measures brain responses during two distinct memory processes - the encoding (learning) and retrieval (remembering) of information
Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Cognitive task performance: Visual affective bias task
Time Frame: Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Measures biases in patients' cognition towards or away from rewarding stimuli
Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Regional activations during neuroimaging task: Facial emotional processing task
Time Frame: Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Measures brain responses to positive, negative and neutral emotions
Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Regional activations during neuroimaging task: Emotional face recognition task
Time Frame: Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Measures brain responses during two distinct memory processes - the encoding (learning) and retrieval (remembering) of information
Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Regional activations during neuroimaging task: Visual affective bias task
Time Frame: Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Measures biases in patients' cognition towards or away from rewarding stimuli
Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Clinical symptom measure: Generalised Anxiety Disorder Scale (GAD-7)
Time Frame: Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Measures symptoms of generalised anxiety, scored between 0-21 with higher scores indicating more severe symptoms
Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Clinical symptom measure: State Trait Anxiety Inventory (STAI)
Time Frame: Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Measures state and trait anxiety symptoms, scored between 20-80 with higher scores indicating more severe symptoms
Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Clinical symptom measures: Patient Health Questionnaire (PHQ-9)
Time Frame: Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Measures depressive symptoms, scored between 0-27 with higher scores indicating more severe symptoms
Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Clinical symptom measures: Beck's Depression Inventory (BDI)
Time Frame: Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Measures depressive symptoms, scored between 0-63 with higher scores indicating more severe symptoms
Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Clinical symptom measures: Catastrophizing questionnaire
Time Frame: Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Measures catastrophising, scored between 24-120 with higher scores indicating more severe symptoms
Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Clinical symptom measures: Daily Stress Inventory (DSI)
Time Frame: Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Measures frequency and impact of daily stresses. Frequency scored between 0-58 and impact scored between 0-6, with higher scores indicating more severe stress
Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Clinical symptom measures: Behavioural Inhibition/Behavioural Activation Scales (BIS/BAS)
Time Frame: Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Measures drive, fun-seeking, reward responsiveness and behavioural inhibition. Behavioural inhibition scored between 7-28, drive between 4-16, fun seeking between 4-16, and reward between 5-20, with higher scores indicating higher levels of those behaviours
Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Clinical symptom measures: Eysenck Impulsiveness Scale
Time Frame: Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Measures impulsiveness, venturesomeness and empathy. Impulsivity scored between 0-19, venturesomeness between 0-16, empathy between 0-18, with higher scores indicating higher levels of those traits
Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood diary
Time Frame: Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
A 'mood diary' will be implemented during the intervention phase which will involve daily self-report rating of mood ('happy', 'anxious' and 'sad')
Day 0, up to 12 weeks (post-CBT or matched time on waiting list)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCLH/UCL Joint Research Office

Collaborators

Medical Research Council
Camden and Islington NHS Trust
Central and North West London NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2020

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

September 7, 2022

First Submitted That Met QC Criteria

September 17, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Actual)

November 18, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 121261
  • 255501 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The data may also be published as open-access data online. In this case, all personally-identifiable data will be removed such that participants cannot be identified from this open data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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