Concussion, MildHEADONNCT05069948
Delivery of Digital Cognitive Behavioural Therapy Following Concussion
A study testing HeadOn in people with Concussion, Mild, run by University of Edinburgh at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Concussion, Mild
- What is being tested?
- HeadOn
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Nov 2021to 22 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Concussion, Mild
- Being tested
- HeadOn
- Keywords
- Cognitive behavioural therapy, Digital health, Traumatic brain injury
- Medical subject headings
- Brain Concussion, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeadOnOther
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.
| Study group | Role | What they receive |
|---|---|---|
| HeadOn intervention | Experimental | Participants are given access to HeadOn - a web application that delivers a CBT programme to patients following concussion. Receives: Other: HeadOn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Compliance With HeadOn Program
Degree of engagement of study participants with the HeadOn program. This was defined as whether the participant entered data into the HeadOn functionality (including symptom diary, sleep time setting, alcohol tracker, exercise day setting, thought diary and goal setter)
Measured: 5 weeks
Secondary outcomes (6)
mHealth App Usability Questionnaire
The mobile Health App Usability Questionnaire (MAUQ) is a validated questionnaire that examine participants' attitudes to an mHealth intervention. MAUQ quantifies respondents' perceptions of the usability of a mobile health app using a range from 1 to 7. A score of 7 indicates a high degree of usability.
Measured: 5 weeks
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. It examines 16 post-concussion symptoms which are rates from 0 (no symptom) to 4 (severe symptom). This gives a range from 0 (o post-concussion symptoms) to 64 (severe post-concessional symptoms).
Measured: 5 weeks
PHQ9 Questionnaire
The Patient Health Questionnaire (PHQ)-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Range include 0 (no depression) to 27 (severe depression).
Measured: 5 weeks
Glasgow Outcome Score Extended
The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status. There are 8 categories that are denoted numerically as follows: Dead (1), Vegetative State (2), Lower Severe Disability (3), Upper Severe Disability (4), Lower Moderate Disability (5), Upper Moderate Disability (6), Lower Good Recovery (7), and Upper Good Recovery (8).
Measured: 5 weeks
Return to Work Rate
Patient self reported outcome measure. Participants were contacted by telephone at the completion of HeadOn (5 weeks from registration) and asked the following question 'Have you returned to work?'. The outcome was dichotomous and was either coded as 'yes' or 'no' based on participant response. The measure was then reported as a return to work rate which was the percentage of participants who reported they had returned to work at the completion of HeadOn.
Measured: 5 weeks
Healthcare Resource Utilisation
Patient Self reported outcome measure. At completion of the HeadOn program (5 weeks from registration), the participants were contacted by telephone and were asked 'Have you sought healthcare professional support due to your post-concussion symptoms since you started using HeadOn?'. The outcome was a dichotomous outcome and was either coded as 'yes' or 'no'. The definition of healthcare professional included: returning to the emergency department, seeing family doctor, a neuropsychologist, physiotherapist or sports medicine doctor). The outcome measure was reported as the percentage of respondents who sought healthcare professional input while using HeadOn.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start8 Nov 2021
- Primary completion11 Mar 2022
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Aimun Jamjoom, FRCS, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069948
- Sponsor's protocol ID
- 2021/0151
- Acronym
- HEADON
- Status last verified
- Dec 2023
- First submitted
- 27 Sep 2021
- Last updated
- 23 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Annonymised study data will be made available on Edinburgh University's DataShare service
Publications
d'Offay C, Ng XY, Alexander L, Grant A, Grahamslaw J, Pagliari C, Reed MJ, Carson A, Gillespie DC, Jamjoom AAB. A Digital Health Intervention for Concussion: Development and Clinical Feasibility Study. JMIR Form Res. 2023 Feb 1;7:e43557. doi: 10.2196/43557.
PubMed 36724010
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivery of Digital Cognitive Behavioural Therapy Following Concussion: HeadOn Feasibility Study
- ClinicalTrials.gov ID
- NCT05069948
- Acronym / sponsor ID
- HEADON / 2021/0151
- Conditions
- Concussion, Mild
- Keywords
- Cognitive behavioural therapy, Digital health, Traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Posted 23 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HeadOn intervention | Experimental | Other: HeadOnParticipants are given access to HeadOn - a web application that delivers a CBT programme to patients following concussion. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeadOnHeadOn 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. | Other | HeadOn intervention |
Primary outcome
Participant Compliance With HeadOn Program
Time frame: 5 weeks
Degree of engagement of study participants with the HeadOn program. This was defined as whether the participant entered data into the HeadOn functionality (including symptom diary, sleep time setting, alcohol tracker, exercise day setting, thought diary and goal setter)
6 secondary outcomes
mHealth App Usability Questionnaire
Time frame: 5 weeks
Rivermead Post-concussion Questionnaire
Time frame: 5 weeks
PHQ9 Questionnaire
Time frame: 5 weeks
Glasgow Outcome Score Extended
Time frame: 5 weeks
Return to Work Rate
Time frame: 5 weeks
Healthcare Resource Utilisation
Time frame: 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36724010d'Offay C, Ng XY, Alexander L, Grant A, Grahamslaw J, Pagliari C, Reed MJ, Carson A, Gillespie DC, Jamjoom AAB. A Digital Health Intervention for Concussion: Development and Clinical Feasibility Study. JMIR Form Res. 2023 Feb 1;7:e43557. doi: 10.2196/43557.
- Individual participant dataSharing planned: Yes. Annonymised study data will be made available on Edinburgh University's DataShare service
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aimun Jamjoom, FRCS principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeadOn in people with Concussion, Mild, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Compliance With HeadOn Program (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05069948, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.