Clinical Trials Logo

Clinical Trial Summary

Concussion is common and patients can go on to suffer with a constellation of symptoms which impacts their functional outcome and quality of life. Patient provision with information about their concussion and subsequent follow-up is highly variable. The investigators have developed HeadOn - a web application that delivers a CBT programme to patients following concussion. In this study, the investigators would like to examine the feasibility of digitally delivering a course of CBT to patients following concussion.


Clinical Trial Description

The HeadOn study is a prospective feasibility study of patients presenting to the Emergency Department (ED). Potentially eligible patients will be contacted by a member of the research team and their consent will be sought for participation. Those not recruited at presentation to the ED will be contacted by telephone, text or email within two weeks of their concussion date to seek their participation in the study, again by a member of the research team. After consenting, the participant will be taken through the registration process for the HeadOn program. For patients who are contacted after discharge they will be taken through registration process over the telephone or if preferable will be able to return to the ED to go over the process. At registration the participant will be invited to complete a series of patient reported measures including the Rivermead post-concussion questionnaire, Pittsburgh Sleep Quality Index, PHQ9 questionnaire and FAST alcohol questionnaire within the HeadOn program. Alongside this, a series of researcher-led anonymised data points will be collected in a separate specially designed database including demographics, date of concussion, neurological and imaging findings which will all be collected from the medical notes and imaging reports. The HeadOn program runs for five weeks following which the participant will be invited to complete the same set of outcome measures. Alongside this, all the participant will be contacted (via telephone, text or email) by a member of the research team at week 5 to complete a further five measurements: Glasgow Outcome Score Extended, mHealth App Usability questionnaire, time to return to work and a healthcare utility questionnaire. Interested participants will be invited back within two months of enrolling in the study for a more detailed qualitative interviews about HeadOn. The study will recruit for a period of 6-months or up to 100 participants. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05069948
Study type Interventional
Source University of Edinburgh
Contact
Status Completed
Phase N/A
Start date November 8, 2021
Completion date April 22, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05849064 - Concussion Treatment in Older Adults N/A
Terminated NCT04586179 - A Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion N/A
Not yet recruiting NCT05943561 - Biomarkers in Concussion
Completed NCT02721537 - Use of 31P MRS to Assess Brain NAD+ in Healthy Current and Former Collegiate Athletes N/A
Completed NCT03236389 - Brain Dynamics in Response to Jugular Vein Compression N/A
Completed NCT01832714 - Assessment of Oculomotor, Vestibular and Reaction Time Response Following a Concussive Event
Completed NCT04560400 - Reverse King-Devick Test and History of Multiple Concussions N/A
Completed NCT03678077 - Trends in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury
Recruiting NCT05262361 - Persistent Post-Concussion Symptoms With Convergence Insufficiency N/A
Recruiting NCT05105802 - Mindfulness-Based Intervention for Mild Traumatic Brain Injury N/A
Terminated NCT03123822 - Spectacles Lens in Concussed Kids N/A
Completed NCT04641832 - The Combined Effect of Chronic Cannabis Use and Subconcussive Head Impacts on Brain Health N/A
Completed NCT04074486 - Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC
Withdrawn NCT04578743 - Exercise as Concussion Therapy Trial- 2 Phase 2
Completed NCT03170856 - The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion N/A
Completed NCT03671083 - Validation of Brain Function Assessment Algorithm for mTBI/Concussion
Recruiting NCT03889483 - Neurophysiological Measurements Using the NeuroCatchâ„¢ Platform in Pediatric Concussion N/A
Withdrawn NCT02959294 - Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries Early Phase 1
Recruiting NCT06093295 - Non-invasive Brain Stimulation and Injury Risk Biomechanics N/A
Completed NCT02280304 - Meditation in Veterans With PTSD and Mild TBI N/A