Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT05549102
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
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT05549102
Study Brief:
Protocol Section:
NCT05549102