Self-directed versus peer-supported digital self-management programmes for mental and sexual wellbeing after acquired brain injury (HOPE4ABI): protocol for a feasibility randomised controlled trial
Abstract Background Acquired brain injury (ABI) can lead to biopsychosocial changes such as depression, low self-esteem and fatigue. These changes can cause, and be caused by, sexual issues affecting relationships and wellbeing. Given the relationship between sexual wellbeing and mental health, it i...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-11-01
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| Series: | Pilot and Feasibility Studies |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40814-023-01421-z |
| _version_ | 1797416037532041216 |
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| author | Hayley Wright Aimee Walker-Clarke Avril Drummond Lisa Kidd Giles Yeates Deborah Williams David McWilliams Wendy Clyne Cain C. T. Clark Peter Kimani Andy Turner |
| author_facet | Hayley Wright Aimee Walker-Clarke Avril Drummond Lisa Kidd Giles Yeates Deborah Williams David McWilliams Wendy Clyne Cain C. T. Clark Peter Kimani Andy Turner |
| author_sort | Hayley Wright |
| collection | DOAJ |
| description | Abstract Background Acquired brain injury (ABI) can lead to biopsychosocial changes such as depression, low self-esteem and fatigue. These changes can cause, and be caused by, sexual issues affecting relationships and wellbeing. Given the relationship between sexual wellbeing and mental health, it is feasible that supporting sexual wellbeing will benefit psychological wellbeing. However, neurorehabilitation is inconsistent and often fragmented across the UK, and psychological, sexual and social support are lacking. Research shows that self-management and peer-support programmes can improve quality of life, self-efficacy and psychological wellbeing after brain injury. This protocol describes a feasibility randomised controlled trial (RCT) of a digital self-management programme to support mental and sexual wellbeing (known as HOPE4ABI), co-designed with and for people with ABI. Methods This mixed-methods feasibility RCT has two parallel trial arms of the 8-week digital HOPE4ABI self-management programme. Eligibility criteria include age > 18 years, diagnosed or suspected ABI > 3 months prior to trial entry, access to an Internet-enabled device and ability to engage with the intervention. Referrals to the study website will be made via the National Health Service (NHS), social media and partnering organisations. Sixty eligible participants will be randomised at a ratio of 1:1 to peer-supported (n = 30) or self-directed (n = 30) HOPE4ABI programmes. Primary feasibility outcomes include recruitment and retention rates, engagement, adherence and usage. Secondary outcomes related to standardised measures of quality of life, sexual wellbeing and mental wellbeing. Participants and peer facilitators will be interviewed after the course to assess acceptability across both trial arms. Discussion This feasibility trial data is not sufficiently powered for inferential statistical analyses but will provide evidence of the feasibility of a full RCT. Quantitative trial data will be analysed descriptively, and participant screening data representing age, ethnicity and gender will be presented as proportions at the group level. These data may indicate trends in reach to particular demographic groups that can inform future recruitment strategies to widen participation. Progression to a definitive trial will be justified if predetermined criteria are met, relating to recruitment, retention, engagement and acceptability. Trial registration ISRCTN46988394 registered on March 1, 2023. |
| first_indexed | 2024-03-09T05:58:00Z |
| format | Article |
| id | doaj.art-2227626b56c84f0d94a9159aedf7ce34 |
| institution | Directory Open Access Journal |
| issn | 2055-5784 |
| language | English |
| last_indexed | 2024-03-09T05:58:00Z |
| publishDate | 2023-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj.art-2227626b56c84f0d94a9159aedf7ce342023-12-03T12:12:04ZengBMCPilot and Feasibility Studies2055-57842023-11-019111210.1186/s40814-023-01421-zSelf-directed versus peer-supported digital self-management programmes for mental and sexual wellbeing after acquired brain injury (HOPE4ABI): protocol for a feasibility randomised controlled trialHayley Wright0Aimee Walker-Clarke1Avril Drummond2Lisa Kidd3Giles Yeates4Deborah Williams5David McWilliams6Wendy Clyne7Cain C. T. Clark8Peter Kimani9Andy Turner10Centre for Intelligent Healthcare, Coventry UniversityCentre for Intelligent Healthcare, Coventry UniversityQueen’s Medical Centre, University of NottinghamSchool of Health & Life Sciences, Glasgow Caledonian UniversityRippling MindsCentre for Intelligent Healthcare, Coventry UniversityCentre for Intelligent Healthcare, Coventry UniversityPeninsula Medical School, University of PlymouthCentre for Intelligent Healthcare, Coventry UniversityWarwick Medical School, University of WarwickCentre for Intelligent Healthcare, Coventry UniversityAbstract Background Acquired brain injury (ABI) can lead to biopsychosocial changes such as depression, low self-esteem and fatigue. These changes can cause, and be caused by, sexual issues affecting relationships and wellbeing. Given the relationship between sexual wellbeing and mental health, it is feasible that supporting sexual wellbeing will benefit psychological wellbeing. However, neurorehabilitation is inconsistent and often fragmented across the UK, and psychological, sexual and social support are lacking. Research shows that self-management and peer-support programmes can improve quality of life, self-efficacy and psychological wellbeing after brain injury. This protocol describes a feasibility randomised controlled trial (RCT) of a digital self-management programme to support mental and sexual wellbeing (known as HOPE4ABI), co-designed with and for people with ABI. Methods This mixed-methods feasibility RCT has two parallel trial arms of the 8-week digital HOPE4ABI self-management programme. Eligibility criteria include age > 18 years, diagnosed or suspected ABI > 3 months prior to trial entry, access to an Internet-enabled device and ability to engage with the intervention. Referrals to the study website will be made via the National Health Service (NHS), social media and partnering organisations. Sixty eligible participants will be randomised at a ratio of 1:1 to peer-supported (n = 30) or self-directed (n = 30) HOPE4ABI programmes. Primary feasibility outcomes include recruitment and retention rates, engagement, adherence and usage. Secondary outcomes related to standardised measures of quality of life, sexual wellbeing and mental wellbeing. Participants and peer facilitators will be interviewed after the course to assess acceptability across both trial arms. Discussion This feasibility trial data is not sufficiently powered for inferential statistical analyses but will provide evidence of the feasibility of a full RCT. Quantitative trial data will be analysed descriptively, and participant screening data representing age, ethnicity and gender will be presented as proportions at the group level. These data may indicate trends in reach to particular demographic groups that can inform future recruitment strategies to widen participation. Progression to a definitive trial will be justified if predetermined criteria are met, relating to recruitment, retention, engagement and acceptability. Trial registration ISRCTN46988394 registered on March 1, 2023.https://doi.org/10.1186/s40814-023-01421-zBrain injurySelf-managementPeer supportSexual wellbeingPsychosocial wellbeingDigital health intervention |
| spellingShingle | Hayley Wright Aimee Walker-Clarke Avril Drummond Lisa Kidd Giles Yeates Deborah Williams David McWilliams Wendy Clyne Cain C. T. Clark Peter Kimani Andy Turner Self-directed versus peer-supported digital self-management programmes for mental and sexual wellbeing after acquired brain injury (HOPE4ABI): protocol for a feasibility randomised controlled trial Pilot and Feasibility Studies Brain injury Self-management Peer support Sexual wellbeing Psychosocial wellbeing Digital health intervention |
| title | Self-directed versus peer-supported digital self-management programmes for mental and sexual wellbeing after acquired brain injury (HOPE4ABI): protocol for a feasibility randomised controlled trial |
| title_full | Self-directed versus peer-supported digital self-management programmes for mental and sexual wellbeing after acquired brain injury (HOPE4ABI): protocol for a feasibility randomised controlled trial |
| title_fullStr | Self-directed versus peer-supported digital self-management programmes for mental and sexual wellbeing after acquired brain injury (HOPE4ABI): protocol for a feasibility randomised controlled trial |
| title_full_unstemmed | Self-directed versus peer-supported digital self-management programmes for mental and sexual wellbeing after acquired brain injury (HOPE4ABI): protocol for a feasibility randomised controlled trial |
| title_short | Self-directed versus peer-supported digital self-management programmes for mental and sexual wellbeing after acquired brain injury (HOPE4ABI): protocol for a feasibility randomised controlled trial |
| title_sort | self directed versus peer supported digital self management programmes for mental and sexual wellbeing after acquired brain injury hope4abi protocol for a feasibility randomised controlled trial |
| topic | Brain injury Self-management Peer support Sexual wellbeing Psychosocial wellbeing Digital health intervention |
| url | https://doi.org/10.1186/s40814-023-01421-z |
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