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

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

Abstract

Objectives
The purpose of this study was to assess feasibility and acceptability of a stroke-specific mindfulness-based intervention called Helping Ease Anxiety and Depression after Stroke (HEADS: UP).

Method
This study was a mixed-methods pilot randomized controlled trial comparing HEADS: UP to treatment as usual (TAU). HEADS: UP is a 9-week mindfulness intervention for stroke survivors. UK (United Kingdon)-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 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.

• Journal Article Type: Article
• Acceptance Date: Apr 27, 2025
• Online Publication Date: May 19, 2025
• Publication Date: May 19, 2025
• Deposit Date: Jul 23, 2025
• Publicly Available Date: Jul 23, 2025
• Journal: Mindfulness
• Print ISSN: 1868-8527
• Electronic ISSN: 1868-8535
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• DOI: https://doi.org/10.1007/s12671-025-02595-8
• Publisher URL: https://link.springer.com/article/10.1007/s12671-025-02595-8
• Additional Information: The version of record of this article, first published in Mindfulness, is available online at Publisher’s website: http://dx.doi.org/10.1007/s12671-025-02595-8