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

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