| NCT ID | NCT05549102 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UCLH/UCL Joint Research Office |
| Condition | Generalised Anxiety Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 174 participants |
| Start Date | 2020-02-02 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 174 participants in total. It began in 2020-02-02 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05549102 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Generalised Anxiety Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05549102 currently recruiting?
Yes, NCT05549102 is actively recruiting participants. Contact the research team at emily.lewis.23@ucl.ac.uk for enrollment information.
Where is the NCT05549102 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT05549102 clinical trial?
NCT05549102 is sponsored by UCLH/UCL Joint Research Office. The trial plans to enroll 174 participants.
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