A novel digital intervention to support mental and sexual wellbeing after stroke and brain injury: A feasibility randomised controlled trial.

ObjectiveTo assess the feasibility of a novel digital self-management intervention (HOPE4ABI) supporting mental and sexual wellbeing for stroke and acquired brain injury survivors.DesignParallel, 1:1 allocation, two-arm feasibility randomised controlled trial.SettingOnline.ParticipantsU.K.-based adults (n = 53) living with any type of acquired brain injury, sustained at least 3 months prior to trial entry.InterventionParticipants were randomly assigned to the self-guided (n = 26) or group-facilitated (n = 27) 8-week online intervention. All participants received identical information and intervention content, but peer-to-peer interactions and facilitation were only available in the group-facilitated arm.Outcome measuresPrimary outcomes were rates of recruitment, retention, engagement and acceptability, measured against a priori criteria. Secondary outcomes were scores on measures of mental wellbeing, sexual wellbeing and quality of life, recorded at baseline, 8 weeks and 6 months.ResultsThe recruitment rate was acceptable (n = 53/73; 72.6%). At 6 months, questionnaire data were available for n = 45/53 (84.9%), thus meeting the progression criteria. Neither the engagement criteria (52.3%, n = 23/44), nor acceptability criteria (75.7%, n = 28/37) were met, and were explored further in post-intervention interviews. Six-month follow-up data showed improvements in mental wellbeing, sexual wellbeing and quality of life relative to baseline.ConclusionsOn balance, a definitive RCT is warranted to evaluate the efficacy and cost-effectiveness of the intervention. The primary feasibility outcomes of recruitment and retention rate met the progression criteria, and engagement and acceptability issues were addressed through participant feedback. There were signals of efficacy noted across all outcome measures at 6-month follow-up.ISRCTN Reg NoISRCTN46988394.