Delivery of Digital Cognitive Behavioural Therapy Following Concussion

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Delivery of Digital Cognitive Behavioural Therapy Following Concussion: HeadOn Feasibility Study

Conditions
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Concussion, Mild

Intervention / Treatment
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* Other: HeadOn


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HeadOn intervention<br>Participants are given access to HeadOn - a web application that delivers a CBT programme to patients following concussion. | Other: HeadOn<br>* HeadOn is a web application which takes the participant through a 5-stage CBT programme including: (i) understanding post-concussion symptoms; (ii) sleep after a concussion; (iii) lifestyle habits and exercise; (iv) managing negative thought patterns and (v) returning to baseline. The programme is delivered through a combination of weekly tasks (such as completing symptom diary, setting exercise goals and setting up a sleep time routine), audio/video media and reading material.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| mHealth App Usability Questionnaire | Validated questionnaire that examine participants' attitudes to an mHealth intervention | On completion of 5 week HeadOn program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Time to return to work | Questions regarding patients return to work and timeframe to achieve this | On completion of 5 week HeadOn program | 
| Healthcare utilisation | Questions on healthcare resource utilisation while using HeadOn program | On completion of 5 week HeadOn program | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive behavioural therapy, Digital health, Traumatic brain injury