Concussion, Mild Clinical Trial
— HEADONOfficial title:
Delivery of Digital Cognitive Behavioural Therapy Following Concussion: HeadOn Feasibility Study
Verified date | November 2021 |
Source | University of Edinburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | April 22, 2022 |
Est. primary completion date | March 11, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - Patients aged 16 years and older (no upper age limit) - Presenting to the ED with a concussion - Concussion defined as a traumatically induced alteration of mental status (either defined as loss of consciousness and/or amnesia) - Patient is Glasgow Coma Scale score of 13-15 on initial presentation to the ED - Patient needs to be able to start using HeadOn within 14 days of their head injury Exclusion Criteria: - Patients aged under 16 years old - Patients requiring surgical management of their cranial injury - Significant other associated injuries requiring hospitalisation (spinal injury, fractures, abdominal, cardiothoracic or vascular injuries) - Does not have capacity to give consent - Non-English speakers - Patient in police custody or in prison |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Edinburgh Royal Infirmary | Edinburgh |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh | NHS Lothian |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participant compliance with HeadOn program | Data inputted into the digital CBT program will be used as surrogate marker of participant compliance. During each stage of the program participants are required to input data as part of the CBT tasks. Participants will be divided into the following three groups: Fully compliant: participants who input data into the program during all five stages; Partially compliant: participants who input data but not during all five stages; Non-compliant: participants who do not enter any data into the program | On completion of 5 week HeadOn program | |
Primary | mHealth App Usability Questionnaire | Validated questionnaire that examine participants' attitudes to an mHealth intervention | On completion of 5 week HeadOn program | |
Secondary | Rivermead post-concussion questionnaire | The Rivermead Post-Concussion Symptom Questionnaire (RPQ) is a self-report scale to measure the severity of post-concussive symptoms following a Traumatic Brain Injury | On completion of 5 week HeadOn program | |
Secondary | PHQ9 questionnaire | The Patient Health Questionnaire (PHQ)-9 is the major depressive disorder (MDD) module of the full PHQ | On completion of 5 week HeadOn program | |
Secondary | Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index (PSQI) measures sleep quality and disturbance retrospectively over a 1-month period using self-reported symptoms and sleep. | On completion of 5 week HeadOn program | |
Secondary | Glasgow Outcome Score Extended | The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status | On completion of 5 week HeadOn program | |
Secondary | Time to return to work | Questions regarding patients return to work and timeframe to achieve this | On completion of 5 week HeadOn program | |
Secondary | Healthcare utilisation | Questions on healthcare resource utilisation while using HeadOn program | On completion of 5 week HeadOn program |
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