At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Cognitive Behavioural Therapy (behavioural), Waiting List (other)
- How long the study runs
- Study runs about 70 months (dates as stated)
- About the drug or intervention
- Cognitive Behavioural Therapy — behavioural: 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. · 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.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years to 64 Years
- Who
- All
- Number of participants
- 174
- Started
- 2020-02-02
- Last checked
- 2025-06
Plain English Summary
What is this study?
- • Testing a new treatment for generalised anxiety disorder
- • Clinical study - 174 participants
- • 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
Who can take part?
- • Ages 18 Years to 64 Years
- • Diagnosed with generalised anxiety disorder
Where?
- • London - Institute of Cognitive Neuroscience, University College London
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
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.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 64 Years
- Who can join: All genders
What the study is looking for
- ✓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
Who cannot take part
- ✗Score above 22 on the GAD-7
- ✗Past/present psychotic disorder, bipolar disorder/mania or alcohol/substance use disorder (outside a comorbid...
- ✗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...
See the full criteria
Where Is This Study? (1 UK site)
Institute of Cognitive Neuroscience, University College London
London WC1N 3AZ, United Kingdom
How to Get in Touch
Emily Lewis
Sponsor contactCONTACT
Oliver Robinson
Sponsor contactCONTACT