Clinical trial NCT05069948: Delivery of Digital Cognitive Behavioural Therapy Following Concussion
Official title: Delivery of Digital Cognitive Behavioural Therapy Following Concussion: HeadOn Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Mild
Keywords: Cognitive behavioural therapy
Digital health
Traumatic brain injury
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2021-10-06
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Participant Compliance With HeadOn Program
timeFrame: 5 weeks
Secondary outcomes:
measure: mHealth App Usability Questionnaire
timeFrame: 5 weeks
measure: Rivermead Post-concussion Questionnaire
timeFrame: 5 weeks
measure: PHQ9 Questionnaire
timeFrame: 5 weeks
measure: Glasgow Outcome Score Extended
timeFrame: 5 weeks
measure: Return to Work Rate
timeFrame: 5 weeks
measure: Healthcare Resource Utilisation
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Edinburgh Royal Infirmary
Study officials:
affiliation: University of Edinburgh
name: Aimun Jamjoom, FRCS
role: PRINCIPAL_INVESTIGATOR
References: