CBT and the Neural Circuits of Anxiety

The Impact of CBT on Shock-Potentiated Neural Circuity

Sponsors

Lead Sponsor: UCLH/UCL Joint Research Office

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

Source UCLH/UCL Joint Research Office
Brief Summary

This study will aim to test whether specific neural circuitry changes, proposed on the basis of our 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.

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). We aim 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.

Overall Status Recruiting
Start Date 2020-02-02
Completion Date 2023-08-01
Primary Completion Date 2023-08-01
Study Type Observational
Primary Outcome
Measure Time Frame
'Aversive amplification circuit' connectivity Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Secondary Outcome
Measure Time Frame
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)
Regional activations during neuroimaging task: Facial emotional processing task Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Regional activations during neuroimaging task: Emotional face recognition task Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Regional activations during neuroimaging task: Visual affective bias task Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Clinical symptom measure: Generalised Anxiety Disorder Scale (GAD-7) Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Clinical symptom measure: State Trait Anxiety Inventory (STAI) Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Clinical symptom measures: Patient Health Questionnaire (PHQ-9) Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Clinical symptom measures: Beck's Depression Inventory (BDI) Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Clinical symptom measures: Catastrophizing questionnaire Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Clinical symptom measures: Daily Stress Inventory (DSI) 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) Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Clinical symptom measures: Eysenck Impulsiveness Scale Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Enrollment 174
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Cognitive Behavioural Therapy

Description: In the treatment 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.

Arm Group Label: Treatment Group

Other Name: CBT

Intervention Type: Other

Intervention Name: Waiting List

Description: 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)

Arm Group Label: Waiting List Group

Eligibility

Sampling Method:

Probability Sample

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

64 Years

Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Status: Contact: Investigator: Institute of Cognitive Neuroscience, University College London Oliver J Robinson, PhD 020 7679 1150 [email protected] Oliver J Robinson, PhD Principal Investigator
Location Countries

United Kingdom

Verification Date

2022-09-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Treatment Group

Description: Participants undergoing a course of Cognitive Behavioural Therapy (CBT)

Label: Waiting List Group

Description: Participants on the Waiting List for CBT

Patient Data Undecided
Study Design Info

Observational Model: Case-Control

Time Perspective: Other

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