ImPACT Stroke II
Research type
Research Study
Full title
ImPACT Stroke II: Improving Psychological wellbeing using Acceptance and Commitment Therapy among stroke survivors with cognitive impairment: a randomised pilot study of an e-Health, carer supported, dyadic intervention
IRAS ID
320990
Contact name
Noleen McCorry
Contact email
Sponsor organisation
Queen's University Belfast
Duration of Study in the UK
1 years, months, days
Research summary
Research Summary
Up to 75% of stroke survivors will experience some form of cognitive difficulty, and as a consequence are less able to access psychological therapies. This situation can compound poor psychological wellbeing, quality of life, and social isolation for stroke survivors and their family. We have designed a brief psychological intervention, called ImpACT Stroke, with significant input from stakeholders, specifically tailored for stroke survivors with cognitive impairment, delivered remotely in a small group involving the stroke survivor and using family members as support persons to help achieve therapeutic goals. Findings from our previous study indicate that the ImpACT Stroke II intervention is likely to be acceptable to stroke survivors and support persons. We now propose a randomised type 1 hybrid effectiveness – implementation (HEI) trial to simultaneously assess the effectiveness of ImpACT Stroke , while observing and gathering information on its implementation.The primary aim is to estimate the likely effect of the ImpACT Stroke intervention compared to usual care on the following outcomes: quality of life, psychological wellbeing and psychological flexibility. Stroke survivors and a ‘support person’ will be randomly allocated to the intervention group or usual care, and will complete assessments at baseline, 6-7 weeks post-baseline and at 3 months post-baseline.
Implementation outcomes will be evaluated using standardised questionnaires and interviews with stakeholders. If the ImpACT Stroke intervention is shown to be potentially effective for improving wellbeing in this underserved population, it would lay the foundation for a large, multi-site randomised trial using evidence-based implementation strategies identified in this hybrid pilot study.
Lay summary of study results:
There were large differences between the intervention group (who received the ImPACT Stroke intervention) and control group (who received usual care only) following completion of the ImPACT Stroke intervention (time 1: 6 weeks after baseline assessment). The intervention group scored lower on the primary outcome measure, Cognitive Fusion. This indicates that (following the intervention) this group were less fused with their thoughts (more cognitive flexibility) than the control group. These large differences were maintained at 3 months post-intervention. In addition there were medium-sized differences between the groups at time 1 on stress, anxiety and distress scores. By time 2 (3 months post-intervention) the size of the differences between the groups on anxiety had reduced considerably, but the size of the difference between groups on depression and stress scores increased, with the intervention group scoring lower on both stress and depression. There was also a medium-sized differences between the intervention and control group on stroke-specific quality of life at time 2, with the intervention group scoring higher. There were significant challenges around recruitment of eligible participants to the pilot trial, particularly among family support persons. Retention of participants within the intervention group (after initiating) was good over of the course of the intervention period, but there was attrition from both intervention and control groups at follow-up. The interventions shows promise, but should be tested within a definitive trial. Other findings around recruitment, attrition etc will inform the design of a future trial.REC name
London - South East Research Ethics Committee
REC reference
23/LO/0046
Date of REC Opinion
16 Jan 2023
REC opinion
Favourable Opinion