Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
174 participants
OBSERVATIONAL
2020-02-02
2025-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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Treatment Group
Participants undergoing a course of Cognitive Behavioural Therapy (CBT)
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.
Waiting List Group
Participants on the Waiting List for CBT
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)
Interventions
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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.
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
64 Years
ALL
No
Sponsors
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Medical Research Council
OTHER_GOV
Camden and Islington NHS Trust
OTHER_GOV
Central and North West London NHS Foundation Trust
OTHER
UCLH/UCL Joint Research Office
OTHER
Responsible Party
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Locations
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Institute of Cognitive Neuroscience, University College London
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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255501
Identifier Type: OTHER
Identifier Source: secondary_id
121261
Identifier Type: -
Identifier Source: org_study_id
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