Delivery of Digital Cognitive Behavioural Therapy Following Concussion

Concussion, Mild Clinical Trial

— HEADON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05069948
• Other study ID #: 2021/0151
• Status: Completed
• Phase: N/A
• Start date: November 8, 2021
• Est. completion date: April 22, 2022

Study information

• Verified date: November 2021
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Mild

Intervention

Other:
• HeadOn
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.

Locations

Country	Name	City	State
United Kingdom	Edinburgh Royal Infirmary	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

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