Delivery of Digital Cognitive Behavioural Therapy Following Concussion (HEADON)
Primary Purpose
Concussion, Mild
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
HeadOn
Sponsored by
About this trial
This is an interventional treatment trial for Concussion, Mild focused on measuring Cognitive behavioural therapy, Digital health, Traumatic brain injury
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
Sites / Locations
- Edinburgh Royal Infirmary
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HeadOn intervention
Arm Description
Participants are given access to HeadOn - a web application that delivers a CBT programme to patients following concussion.
Outcomes
Primary Outcome Measures
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
mHealth App Usability Questionnaire
Validated questionnaire that examine participants' attitudes to an mHealth intervention
Secondary Outcome Measures
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
PHQ9 questionnaire
The Patient Health Questionnaire (PHQ)-9 is the major depressive disorder (MDD) module of the full PHQ
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.
Glasgow Outcome Score Extended
The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status
Time to return to work
Questions regarding patients return to work and timeframe to achieve this
Healthcare utilisation
Questions on healthcare resource utilisation while using HeadOn program
Full Information
NCT ID
NCT05069948
First Posted
September 27, 2021
Last Updated
April 27, 2022
Sponsor
University of Edinburgh
Collaborators
NHS Lothian
1. Study Identification
Unique Protocol Identification Number
NCT05069948
Brief Title
Delivery of Digital Cognitive Behavioural Therapy Following Concussion
Acronym
HEADON
Official Title
Delivery of Digital Cognitive Behavioural Therapy Following Concussion: HeadOn Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
March 11, 2022 (Actual)
Study Completion Date
April 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
NHS Lothian
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Mild
Keywords
Cognitive behavioural therapy, Digital health, Traumatic brain injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HeadOn intervention
Arm Type
Experimental
Arm Description
Participants are given access to HeadOn - a web application that delivers a CBT programme to patients following concussion.
Intervention Type
Other
Intervention Name(s)
HeadOn
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participant compliance with HeadOn program
Description
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
Time Frame
On completion of 5 week HeadOn program
Title
mHealth App Usability Questionnaire
Description
Validated questionnaire that examine participants' attitudes to an mHealth intervention
Time Frame
On completion of 5 week HeadOn program
Secondary Outcome Measure Information:
Title
Rivermead post-concussion questionnaire
Description
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
Time Frame
On completion of 5 week HeadOn program
Title
PHQ9 questionnaire
Description
The Patient Health Questionnaire (PHQ)-9 is the major depressive disorder (MDD) module of the full PHQ
Time Frame
On completion of 5 week HeadOn program
Title
Pittsburgh Sleep Quality Index
Description
The Pittsburgh Sleep Quality Index (PSQI) measures sleep quality and disturbance retrospectively over a 1-month period using self-reported symptoms and sleep.
Time Frame
On completion of 5 week HeadOn program
Title
Glasgow Outcome Score Extended
Description
The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status
Time Frame
On completion of 5 week HeadOn program
Title
Time to return to work
Description
Questions regarding patients return to work and timeframe to achieve this
Time Frame
On completion of 5 week HeadOn program
Title
Healthcare utilisation
Description
Questions on healthcare resource utilisation while using HeadOn program
Time Frame
On completion of 5 week HeadOn program
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimun Jamjoom, FRCS
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edinburgh Royal Infirmary
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Delivery of Digital Cognitive Behavioural Therapy Following Concussion
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