A pilot randomized controlled trial testing the feasibility and acceptability of Helping Ease Anxiety and Depression After Stroke (HEADS: UP): an online mindfulness-based intervention for stroke survivors

Maggie Lawrence*, Bridget Davis, Naomi E. Clark, Jo Booth, Graeme Donald, Nadine Dougall, Linda Fenocchi, Madeleine Grealy, Michelle Jamieson, Bheutesh Jani, Eirini Kontou, Jennifer MacDonald, Helen Mason, Margaret Maxwell, Ben Parkinson, Matilde Pieri, Xu Wang, Stewart W. Mercer

*Corresponding author for this work

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Abstract

Objectives: To assess feasibility and acceptability of a stroke-specific mindfulness-based intervention called Helping Ease Anxiety and Depression after Stroke (HEADS: UP).

Method: Mixed-methods pilot RCT (randomized controlled trial) comparing HEADS: UP to treatment as usual (TAU). HEADS: UP is a 9-week mindfulness intervention for stroke survivors. UK (United Kingdom)-based stroke survivors were recruited and attended HEADS:UP Online. Psychological functioning outcomes measures and other data were collected online at pre-intervention (week 0), post-intervention (week 9), and follow-up (months 3 and 6). Participants were randomized 1:1 to either HEADS: UP or TAU.

Results: Sixty-two participants completed baseline questionnaires and were randomized to HEADS: UP (n = 30) or TAU (n = 32). Retention rates were as follows: HEADS: UP (n = 25, 83.30%) versus TAU (n = 25, 78.10%) at post-intervention, HEADS: UP (n = 24, 80%) versus TAU (n = 26, 81.30%) at 3-month follow-up, and HEADS: UP (n = 20, 66.70%) versus TAU (n = 25, 78.10%) at 6-month follow-up. The mean age for HEADS: UP was 56.0 years versus 56.80
for TAU. The HEADS: UP group was 30% male, while the TAU group was 56% male. Depression Anxiety Stress Scales (DASS)-21 total mean score for HEADS: UP improved in the direction of expected effect (baseline 46.20, SD (standard deviation) = 24.00; post-intervention 24.00, SD = 16.10) indicating ‘recovery’ versus ‘no reliable change’ for TAU (baseline 36.10, SD = 18.70; post-intervention 31.60, SD = 20.40). HEADS: UP and TAU scores continued to
improve over time. Between-group effect sizes (Cohen’s d) at post-intervention were large for 2 BAI (Beck Anxiety Inventory) (d = 0.91), DASS-21 total (d = 0.89), and BDI (Beck Depression Inventory)-II (d = 0.86), highlighting the potential of HEADS: UP for improving depression and anxiety symptoms. At the six-month follow-up, the attrition rate was higher in the HEADS: UP group (33.30%) compared with TAU (21.90%).

Conclusions: HEADS: UP is feasible and acceptable and has potential to improve depression and anxiety symptoms for stroke survivors.

Preregistration: ClinicalTrials.gov: NCT04985838.
Original languageEnglish
Number of pages14
JournalMindfulness
Early online date19 May 2025
DOIs
Publication statusE-pub ahead of print - 19 May 2025

Keywords

  • Anxiety
  • Depression
  • Online MBSR (Mindfulness Based Stress Reduction)
  • Pilot RCT
  • Stroke

ASJC Scopus subject areas

  • Social Psychology
  • Health(social science)
  • Experimental and Cognitive Psychology
  • Developmental and Educational Psychology
  • Applied Psychology

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