A novel targeted treatment for reducing anxiety in joint hypermobility

Not Applicable

• Conditions: Anxiety in patients with joint hypermobility; Mental and Behavioural Disorders

• Registration Number: ISRCTN17018615
• Lead Sponsor: niversity of Sussex

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-20
• Last Update Posted: 18 October 2021
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anxiety levels as measured by Beck Anxiety Inventory (BAI) at T1 (end of therapy)

Secondary Outcome Measures

Name	Time	Method
<br> 1. Autonomic trait prediction error (measured from z score of objective signs of orthostatic intolerance (heart rate rise on active stand test) – subjective symptoms of orthostatic intolerance (orthostatic intolerance subscale of Autonomic Symptoms and Quality of Life Questionnaire (ASQoLS) at T0 (baseline assessment) to T1 (end of therapy)<br> 2. Interoception measures, including:<br> 2.1. Interoceptive sensibility as described by score on awareness subscale of Porges Body Perception Questionnaire, at T0 and T1<br> 2.2. Interoceptive accuracy as defined by performance on the heart beat tracking and heart beat discrimination tasks, at T0 and T1<br> 2.3. Interoceptive awareness as defined by correlation between accuracy and Visual Analogue Scales of confidence in accuracy, at T0 and T1<br> 3. Functional neural datasets – significant changes in activation between T0 and T1<br>