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A feasibility trial of digital support for mental and sexual wellbeing after brain injury

Digital self-management for mental and sexual wellbeing after acquired brain injury (HOPE4ABI): feasibility randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN46988394
Enrollment
60
Registered
2023-03-01
Start date
2023-06-28
Completion date
Unknown
Last updated
2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental and sexual wellbeing after acquired brain injury Not Applicable

Interventions

The HOPE4ABI intervention will be hosted on a digital platform owned by Hope for The Community (H4C) Community Interest Company, a research social enterprise spinout company from Coventry University (
‘IG’) uses forums and messaging facilities that act as a conduit for communication between participants, peers and facilitators. The self-directed HOPE4ABI course (Control Group
‘CG’) contains all the same material but does not include peer support or interaction with other participants. HOPE4ABI is asynchronous, and content is released at set times over the 8 weeks, e.g., at

Sponsors

Coventry University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Ages =18 years old 2. UK-based 3.1. Diagnosed ABI (including head injury, stroke, meningitis, brain tumour, encephalitis, hydrocephalus, cerebral abscess, anoxic brain injury, carbon monoxide poisoning, encephalopathy, cerebral oedema, compression of the brain) =3 months prior to trial entry, category B/C/D on Patient Categorisation Tool 3.2. OR suspected ABI, with corresponding self-reported history of brain injury, behavioural, psychological, physical, or emotional difficulties (reported at self-referral / research nurse screening phase), =3 months prior to trial entry 4. Capacity to give informed consent 5. Ability to communicate in English, participate in the intervention and complete outcome measures 6. Internet connection and an internet-enabled device

Exclusion criteria

Exclusion criteria: 1. Self-reported severe mental illness (e.g. schizophrenia) 2. Diagnosis of dementia or other neurodegenerative disorder 3. Drug- or alcohol-dependency 4. Actively suicidal or attempted suicide in the last 3 months

Design outcomes

Primary

MeasureTime frame
1. Referral rate measured using the responses on the screening log by Research Nurse (for NHS referrals) and responses on an automated screening questionnaire on the study website (for self-referrals) 2. Refusal rate for NHS referrals, defined as the proportion of eligible participants who explicitly declined information about the study when approached by the Research Nurse, measured using data recorded in the screening log 3. Recruitment rate, defined as the proportion of eligible/referred participants who went on to provide consent and complete baseline questionnaires (see below for questionnaire details) 4. Enrolment rate, defined as how many of the participants recruited log into the HOPE4ABI course on the platform, measured using H4C platform analytics 5. Engagement rate, defined as how many of those enrolled go on to access at least 4 modules, measured using H4C platform analytics 6. Follow-up rate, defined as how many of those recruited went on to complete the follow-up questionnaires at T1 and T2, measured using the number of responses on Qualtrics 7. Retention rate, defined as the proportion of participants recruited who engaged with the intervention AND completed follow up questionnaires, measured by combination of Engagement and Follow Up rates described above 8. Withdrawal rate, defined as how many recruited participants explicitly withdrew their consent to take part in the study, measured using the number of email requests to withdraw 9. Acceptability addressing elements of the intervention such as usability, usefulness, relevance of the content, appropriateness of the content, format and delivery, and participants’ overall satisfaction with the intervention measured using quantitative and qualitative methods comprising: 9.1. A multiple choice or Likert-scale format feedback survey at the end of the 8-week intervention. This is a bespoke questionnaire developed by H4C for evaluating participant experience on various Hope programmes. 9.2. Semi-s

Secondary

MeasureTime frame
Participant wellbeing outcomes measured using standardised validated questionnaires, at baseline, 8 weeks (T1), and 6 months (T2): 1. Mental wellbeing measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) 2. Sexuality following brain injury measured using the Brain Injury Questionnaire of Sexuality (BIQS) 3. Health-related quality of life measured using the Quality of Life after Brain Injury – Overall Scale (QOLIBRI-OS) Participants’ mental wellbeing is also monitored across the 8-week intervention period by the Short Version of The Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS) embedded within the digital intervention at week 1, week 4 and week 7.

Countries

England, United Kingdom

Contacts

Public ContactAimee Walker Clarke
ab5746@coventry.ac.ukNone provided

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026