A novel targeted treatment for reducing anxiety in joint hypermobility: a proof of concept study

niversity of Sussex0 sites50 target enrollmentFebruary 20, 2019

Overview

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34548065/ protocol (added 06/10/2021)

Registry

who.int

Start Date

February 20, 2019

End Date

December 1, 2021

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Sussex

•1\. Age: All adults aged 18 years or over
•2\. Capacity: All participants must be able to give informed consent
•3\. Joint hypermobility: Diagnosis of hypermobile Ehlers Danlos Syndrome/Hypermobility Spectrum Disorder/Joint Hypermobility Syndrome OR Score of 2 or more on Hakim and Grahame 5\-point questionnaire to detect Joint Hypermobility
•4\. Anxiety: Self\-reported lived experience of Anxiety disorder AND a score of 16 or more on Beck Anxiety Inventory endorsing moderate anxiety level AND Anxiety should be the primary psychiatric problem
•5\. Medication use: All participants should be on a stable dose of medication for 3 months OR Medication free AND willing to consider omitting medication that directly affects heart rate (e.g. beta blockers) during the trial
•6\. Language: All participants must have a good level of both written and spoken English as therapies and assessments will be conducted in English
•7\. MRI safety: For Phase II (ADAPT TRIAL) only all participants must be MRI safe (i.e no non\-removable metal work in body) and be able to lie flat comfortably for one hour

•1\. Age: Participants under the age of 18
•2\. Capacity: Unable to give informed consent
•3\. Joint hypermobility: No diagnosis of hEDS/HSD/JHS AND score of 1 or less on Hakim and Grahame 5 point questionnaire to detect Joint Hypermobility
•4\. Anxiety: No Self\-reported lived experience of anxiety disorder OR a score of 15 or less on Beck Anxiety Inventory OR anxiety is not the primary psychiatric problem
•5\. Other psychiatric disorder: Presence of major psychiatric disorder (other than co\-morbid depression) e.g. Bipolar Affective Disorder, Schizophrenia or Psychosis OR Personality Disorder (e.g. Emotionally Unstable Personality Disorder) OR diagnosed Neurodevelopmental disorder such as Attention Deficit Hyperactivity Disorder or Autism Spectrum Condition OR Neurological disorder
•6\. Medication use: Not on a stable dose of medication (or medication free) for 3 months
•7\. Language: Poor level of both written and spoken English
•8\. MRI safety: For Phase II (ADAPT TRIAL) only MRI incompatability (i.e. non\-removable metal work in body) OR be unable to lie flat comfortably for one hour
•9\. Psychological therapy: Currently receiving another modality of talking therapy