Clinical trial NCT05549102: CBT and the Neural Circuits of Anxiety
Official title: The Impact of CBT on Shock-Potentiated Neural Circuity
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: UCLH/UCL Joint Research Office
Sponsor class: OTHER
Collaborators: name: Medical Research Council
name: Camden and Islington NHS Trust
name: Central and North West London NHS Foundation Trust
First posted: 2022-09-22
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals entering IAPT services (IAPT step 3; i.e., full CBT) for anxiety disorders

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.

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.

Eligibility 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

Primary outcomes:
measure: 'Aversive amplification circuit' connectivity
timeFrame: Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Secondary outcomes:
measure: Cognitive task performance: Loss/risk aversion task
timeFrame: Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
measure: Cognitive task performance: Go/no-go task
timeFrame: Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
measure: Cognitive task performance: Facial emotional processing task
timeFrame: Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
measure: Cognitive task performance: Emotional face recognition task
timeFrame: Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
measure: Cognitive task performance: Visual affective bias task
timeFrame: Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
measure: Regional activations during neuroimaging task: Facial emotional processing task
timeFrame: Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
measure: Regional activations during neuroimaging task: Emotional face recognition task
timeFrame: Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
measure: Regional activations during neuroimaging task: Visual affective bias task
timeFrame: Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
measure: Clinical symptom measure: Generalised Anxiety Disorder Scale (GAD-7)
timeFrame: Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
measure: Clinical symptom measure: State Trait Anxiety Inventory (STAI)
timeFrame: Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
measure: Clinical symptom measures: Patient Health Questionnaire (PHQ-9)
timeFrame: Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
measure: Clinical symptom measures: Beck's Depression Inventory (BDI)
timeFrame: Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
measure: Clinical symptom measures: Catastrophizing questionnaire
timeFrame: Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
measure: Clinical symptom measures: Daily Stress Inventory (DSI)
timeFrame: Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
measure: Clinical symptom measures: Behavioural Inhibition/Behavioural Activation Scales (BIS/BAS)
timeFrame: Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
measure: Clinical symptom measures: Eysenck Impulsiveness Scale
timeFrame: Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Other outcomes:
measure: Mood diary
timeFrame: Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
Locations:
city: London
country: United Kingdom
facility: Institute of Cognitive Neuroscience, University College London
Study officials:
References: