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

Objective: To assess the feasibility of a novel digital self-management intervention (HOPE4ABI) supporting mental and sexual wellbeing for stroke and acquired brain injury survivors
Design: Parallel, 1:1 allocation, feasibility randomised controlled trial with two arms.
Setting: Online.
Participants: UK-based adults (n=53) living with any type of acquired brain injury, sustained at least 3 months prior to trial entry.
Intervention: Participants were randomly assigned to either 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 measures: Primary 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.
Results: The recruitment rate relative to the target was acceptable (n=53 recruited / n=60 target; 88.3%). At 6-months, questionnaire data were available for n=45 (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. The 6-month follow-up data showed improvements in mental wellbeing, sexual wellbeing, and quality of life relative to baseline.
Conclusions: On 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.