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Completed

NCT Number: NCT05069948

Delivery of Digital Cognitive Behavioural Therapy Following Concussion

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.

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Key information

Conditions

Concussion, Mild Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edinburgh Royal Infirmary

Edinburgh, EH16 4SA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HeadOn

Other

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 outcomes

  1. 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)

Secondary outcomes

  1. mHealth App Usability Questionnaire

    Time frame: 5 weeks

    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.

  2. Rivermead Post-concussion Questionnaire

    Time frame: 5 weeks

    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).

  3. PHQ9 Questionnaire

    Time frame: 5 weeks

    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).

  4. Glasgow Outcome Score Extended

    Time frame: 5 weeks

    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).

  5. Return to Work Rate

    Time frame: 5 weeks

    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.

  6. Healthcare Resource Utilisation

    Time frame: 5 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Lothian

Registry information

Official study title

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

Acronym: HEADON

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 6, 2021
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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