Delivery of Digital Cognitive Behavioural Therapy Following Concussion

NCT05069948 | Completed Results

• 1 other identifier: 2021/0151
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Mild

Keywords

Cognitive behavioural therapy; Digital health; Traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• 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)

  5 weeks

Secondary Outcomes (6)

• mHealth App Usability Questionnaire

  5 weeks

• Rivermead Post-concussion Questionnaire

  5 weeks

• PHQ9 Questionnaire

  5 weeks

• Glasgow Outcome Score Extended

  5 weeks

• Return to Work Rate

  5 weeks

Study Arms (1)

HeadOn intervention

EXPERIMENTAL

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

Other: HeadOn

Interventions

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.

HeadOn intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Edinburgh Royal Infirmary

Edinburgh, EH16 4SA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36724010 DERIVED

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Results Point of Contact

• Title: Aimun Jamjoom
• Organization: The University of Edinburgh and NHS Lothian

v1ajamjo@ed.ac.uk

0131 536 1000

Study Officials

• Aimun Jamjoom, FRCS

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 6, 2021
• Study Start: November 8, 2021
• Primary Completion: March 11, 2022
• Study Completion: April 22, 2022
• Last Updated: October 23, 2024
• Results First Posted: October 23, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available for 5 years after completion of the study

Locations

GB (1)