N/A N=50 Treatment

Delivery of Digital Cognitive Behavioural Therapy Following Concussion

Concussion, Mild

Bottom Line

View on ClinicalTrials.gov: NCT05069948 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcome: Primary: Participant Compliance With HeadOn Program — 45; 5 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: HeadOn (Other)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: University of Edinburgh
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Participant Compliance With HeadOn Program	45; 5	—
SECONDARY mHealth App Usability Questionnaire	6.1	—
SECONDARY Rivermead Post-concussion Questionnaire	16	—
SECONDARY PHQ9 Questionnaire	8	—
SECONDARY Glasgow Outcome Score Extended	8	—
SECONDARY Return to Work Rate	10	—
SECONDARY Healthcare Resource Utilisation	10	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05069948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.