Efficacy of DigitaL cognitive behavioural Therapy to reduce symptoms of anxiety in adults with generalised Anxiety disorder: a randomised controlled trial

niversity of Oxford0 sites256 target enrollmentJanuary 11, 2019

Overview

Registry

who.int

Start Date

January 11, 2019

End Date

June 1, 2020

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

•Current participant inclusion criteria as of 18/09/2019:
•1\. Aged 18\+ years.
•2\. A score of 10 or higher on the Generalised Anxiety Disorder questionnaire (GAD\-7\) indicating at least moderate GAD symptom severity.
•3\. Screen positive for a GAD diagnosis on a digital version of the MINI International Neuropsychiatric Interview (MINI) version 7 for DSM\-5\.
•4\. Must be either not on psychotropic medication or on a stable dose for at least 4 weeks.
•5\. Must not be currently receiving or have previously received CBT for anxiety in the last 12 months.
•Previous participant inclusion criteria:
•1\. Aged 18\+ years
•2\. A score of 10 or higher on the Generalised Anxiety Disorder questionnaire (GAD\-7\) indicating at least moderate GAD symptom severity
•3\. Screen positive for a GAD diagnosis on a digital version of the MINI International Neuropsychiatric Interview (MINI) version 7 for DSM\-5

•1\. Past or present seizure disorder or a clinically significant head trauma (e.g. brain damage)
•2\. Substance use disorder
•3\. Serious physical health concerns necessitating surgery or with prognosis \< 6 months
•4\. Current bipolar disorder, psychosis, or schizophrenia
•5\. Severe cognitive impairment that does not allow participants to consent or follow treatment instructions
•6\. Pregnancy