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Delivery of Digital Cognitive Behavioural Therapy Following Concussion
NA trial testing HeadOn in Concussion, Mild in 50 participants. Completed in 22 April 2022.
| Lead sponsor | University of Edinburgh |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 8 November 2021 |
| Primary completion | 11 March 2022 |
| Estimated completion | 22 April 2022 |
| Sites | 1 location across United Kingdom |
University of Edinburgh
16 and older, any sex, with Concussion, Mild. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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)
| Group | Value | 95% CI |
|---|---|---|
| HeadOn Cohort | 45 | |
| HeadOn Cohort | 5 |
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.
| Group | Value | 95% CI |
|---|---|---|
| HeadOn Cohort | 6.1 | ± 1.3 |
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).
| Group | Value | 95% CI |
|---|---|---|
| HeadOn Cohort | 16 | ± 13 |
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).
| Group | Value | 95% CI |
|---|---|---|
| HeadOn Cohort | 8 | ± 7 |
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).
| Group | Value | 95% CI |
|---|---|---|
| HeadOn Cohort | 8 | 4 – 8 |
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.
| Group | Value | 95% CI |
|---|---|---|
| HeadOn Cohort | 10 |
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 respond
| Group | Value | 95% CI |
|---|---|---|
| HeadOn Cohort | 10 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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