Delivery of Digital Cognitive Behavioural Therapy Following Concussion

NCT ID: NCT05069948

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-08
• Study Completion Date: 2022-04-22

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.

Conditions

Concussion, Mild

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HeadOn intervention

Participants are given access to HeadOn - a web application that delivers a CBT programme to patients following concussion.

Group Type: EXPERIMENTAL

HeadOn

Intervention Type: 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.

Interventions

HeadOn

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Lothian

OTHER_GOV

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aimun Jamjoom, FRCS

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

Edinburgh Royal Infirmary

Edinburgh, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 36724010 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2021/0151

Identifier Type: -

Identifier Source: org_study_id