Psychological interventions for improvement of symptoms of post-stroke depression - study protocol of the...

Besides functional outcomes, mental health and health-related quality of life (HRQoL) are significant measures in chronic diseases, such as stroke. Post-stroke depression (PSD) is an important complication affecting up to one in three stroke survivors. So far, specific programs to screen, detect and treat these patients are lacking but might be a crucial component in stroke aftercare.

Between March 2024 and Febuary 2025 all consecutive adult patients with stroke, admitted to the University Hospital of Augsburg, are screened for signs of depression (PHQ-9 (Patient Health Questionnaire-9) score of ≥ 10). Eight weeks later, those patients with persisting signs of depression will be randomized to receive either a behavioural activation intervention or a mindfulness-based intervention via telephone. Depressive symptoms will be assessed at baseline (V1), after 84, 180 (V2-V3) and after 365 days (V4) using the PHQ-9 score. Secondary outcomes include the functional outcome, quality of life (EuroQol-5 Dimensions; EQ-5D), overall functioning, and incidence of major cardiovascular events including recurrent transient ischemic attack, stroke, and mortality.

Our aim is to provide proof-of-concept evidence for the efficacy of telepsychological need-adapted interventions for patients with post-stroke depression. Regular screening for PSD with implementation of a feasible treatment option could reduce the long-term prevalence of PSD and improve quality of life.

This trial was registered at German Clinical Trials Register (DRKS) on 07.03.2024, ID: DRKS00033792. German Clinical Trials Register (drks.de).