Trial Outcomes & Findings for Delivery of Digital Cognitive Behavioural Therapy Following Concussion (NCT NCT05069948)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

5 weeks

Results posted on

2024-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	HeadOn Intervention Participants are given access to HeadOn - a web application that delivers a CBT programme to patients following concussion. 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.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HeadOn Intervention n=50 Participants Participants are given access to HeadOn - a web application that delivers a CBT programme to patients following concussion. 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.
Age, Continuous	41.9 years STANDARD_DEVIATION 16 • n=50 Participants
Sex: Female, Male Female	27 Participants n=50 Participants
Sex: Female, Male Male	23 Participants n=50 Participants
Region of Enrollment United Kingdom	50 participants n=50 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	HeadOn Cohort n=50 Participants Cohort of 50 study participants using HeadOn
Participant Compliance With HeadOn Program Symptom diary compliance	45 Participants
Participant Compliance With HeadOn Program Non-compliance	5 Participants

SECONDARY outcome

Timeframe: 5 weeks

Population: Only 29 (out of 50) participants responded to this questionnaire

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.

Outcome measures

Outcome measures
Measure	HeadOn Cohort n=29 Participants Cohort of 50 study participants using HeadOn
mHealth App Usability Questionnaire	6.1 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	HeadOn Cohort n=22 Participants Cohort of 50 study participants using HeadOn
Rivermead Post-concussion Questionnaire	16 score on a scale Standard Deviation 13

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	HeadOn Cohort n=22 Participants Cohort of 50 study participants using HeadOn
PHQ9 Questionnaire	8 score on a scale Standard Deviation 7

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	HeadOn Cohort n=29 Participants Cohort of 50 study participants using HeadOn
Glasgow Outcome Score Extended	8 Score on a scale Interval 4.0 to 8.0

SECONDARY outcome

Timeframe: 5 weeks

Population: 25 participants responded to this outcome measure

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.

Outcome measures

Outcome measures
Measure	HeadOn Cohort n=25 Participants Cohort of 50 study participants using HeadOn
Return to Work Rate	10 Participants

SECONDARY outcome

Timeframe: 5 weeks

Population: 29 participants responded to this outcome measure

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.

Outcome measures

Outcome measures
Measure	HeadOn Cohort n=29 Participants Cohort of 50 study participants using HeadOn
Healthcare Resource Utilisation	10 Participants

Adverse Events

HeadOn Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aimun Jamjoom

The University of Edinburgh and NHS Lothian

Phone: 0131 536 1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place