CBT and the Neural Circuits of Anxiety

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

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-64

SponsorUCLH/UCL Joint Research Office

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

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.
Waiting List
Other intervention
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)

Treatment groups

174 Participants

are divided into 2 treatment groups

Group A: Treatment Group1 intervention

Group B: Waiting List Group1 intervention

Trial outcomes

Primary outcomes

'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.

Time frame