In-person and online mixed method non-randomised studies exploring feasibility and acceptability of HEADS: UP, an adapted Mindfulness Based Stress Reduction programme for stroke survivors experiencing symptoms of anxiety and depression (preprint)

ABSTRACT

Background Depression and anxiety are prevalent after stroke and associated with poor outcomes. We previously co-developed a stroke-specific self-management intervention, HEADS UP (Helping Ease Anxiety and Depression after Stroke). The two studies reported here aimed to test the feasibility and acceptability of the HEADS UP course and supporting materials, and research processes ahead of a definitive trial. Methods We recruited community-dwelling stroke survivors (SS) ≥3 months post-stroke, with symptoms of mood disorder (Hospital Anxiety and Depression Scale ≥8). Participants could ‘enrol’ a family member/‘other’ to take part with them, if desired. Study 1 tested HEADS UP delivered in-person, and informed optimisation of research processes and intervention delivery and materials. In response to Covid-related socialising restrictions HEADS UP was then adapted for online delivery; tested in Study 2. The primary outcome (both studies) was feasibility (acceptability, fidelity) of the intervention and of research processes. Quantitative data (including patient reported outcomes measures (PROMs) assessing mood and quality of life), and qualitative data were collected pre-/post-intervention. Descriptive statistics were used to analyse quantitative data; a thematic framework approach was used to analyse qualitative data. Both studies received ethical approval prior to commencement. Results Study 1 Feasibility 13 (59.1%) of 22 potentially eligible stroke survivors consented; aged 66 (median, IQR 14); male (n=9; 69%); 28 (IQR 34; 13.5-48) months poststroke. Of these n=10 (76.9%) completed PROMS pre-intervention; n=6 (46.2%) post-intervention. Acceptability Six (85.7%) stroke survivors attended ≥4 core intervention sessions. Aspects of screening and data collection were found to be burdensome. Study 2 Feasibility SS n=9 (41%) of 22 potentially eligible stroke survivors consented; aged 58 years (median; IR 12); male (n=4; 44.4%); 23 (IQR 34; 10-38) months poststroke. Of these n=5 (55.6%) completed PROMS pre-intervention; n=5 (55.6%) post-intervention. Acceptability Five (55.6%) stroke survivors attended ≥ 4 core sessions. They found online screening and data collection processes straightforward. Conclusions Stroke survivors found in-person and online HEADS UP intervention and research processes feasible and acceptable. A pilot RCT is warranted, after making the adaptations to intervention delivery and research processes identified in this feasibility and acceptability research. Trial registration Study 1 (in-person delivery) ClinicalTrials.gov NCT03956693, registered 20 May 2019, https//www.clinicaltrials.gov/study/NCT03956693 Study 2 (online delivery) ClinicalTrials.gov NCT04567472, registered 23, September 2020, https//clinicaltrials.gov/study/NCT04567472?tab=results: