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

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Lawrence, Maggie and Davis, Bridget and Clark, Naomi E. and Booth, Jo and Donald, Graeme and Dougall, Nadine and Fenocchi, Linda and Grealy, Madeleine and Jamieson, Michelle and Jani, Bhautesh and Kontou, Eirini and MacDonald, Jennifer and Mason, Helen and Maxwell, Margaret and Parkinson, Ben and Pieri, Matilde and Wang, Xu and Mercer, Stewart W. (2025) 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. Mindfulness, 16 (7). pp. 1862-1875. ISSN 1868-8535 (https://doi.org/10.1007/s12671-025-02595-8)

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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.

ORCID iDs

Lawrence, Maggie, Davis, Bridget, Clark, Naomi E., Booth, Jo, Donald, Graeme, Dougall, Nadine, Fenocchi, Linda, Grealy, Madeleine ORCID logoORCID: https://orcid.org/0000-0002-2823-8841, Jamieson, Michelle, Jani, Bhautesh, Kontou, Eirini, MacDonald, Jennifer, Mason, Helen, Maxwell, Margaret, Parkinson, Ben, Pieri, Matilde, Wang, Xu and Mercer, Stewart W.;
CORE (COnnecting REpositories)