Delivery of Digital Cognitive Behavioural Therapy Following Concussion (HEADON)

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

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.

Study Overview

• Status: Completed
• Conditions: Concussion, Mild
• Intervention / Treatment: Other: HeadOn

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom, EH16 4SA
    • Edinburgh Royal Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: HeadOn intervention; Participants are given access to HeadOn - a web application that delivers a CBT programme to patients following concussion.

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: NHS Lothian
• Investigators: Principal Investigator: Aimun Jamjoom, FRCS, University of Edinburgh

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Actual): March 11, 2022
• Study Completion (Actual): April 22, 2022

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Traumatic brain injury; Cognitive behavioural therapy; Digital health
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: 2021/0151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Annonymised study data will be made available on Edinburgh University's DataShare service
• IPD Sharing Time Frame: Data will be available for 5 years after completion of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No