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ObjectiveThere is little randomized controlled trial (RCT) evidence to guide treatment for anxiety after stroke. We systematically reviewed RCTs of anxiety interventions in acquired brain injury (ABI) conditions including stroke and traumatic brain injury (TBI) in order to summarize efficacy and key aspects of trial design to help guide future RCTs.MethodsWe searched the Cochrane trial register, Medline, Embase, PsychInfo and CINAHL systematically up to August 2017. Two independent reviewers systematically selected studies and extracted data. We summarized the effect size, key study characteristics and sources of potential bias in trial design.Results14 studies (12 stroke; one stroke & TBI; one TBI) with 928 participants were included. Meta-analysis of five psychotherapy comparisons favoured intervention over control (standardized mean difference (SMD): -0.41 [-0.79, -0.03], I2=28%); Overall effect size of pharmacotherapy comparisons favoured intervention over control (SMD: -2.12 [-3.05, -1.18], I2=89%). One comparison of mixed pharmacotherapy and psychotherapy favoured intervention over usual care (SMD: -4.79 [-5.87, -3.71]). One comparison favoured forest therapy versus urban control (SMD: -2.00 [-2.59, -1.41]). All positive studies carried high or unclear risk of bias. Sample sizes were small in all included studies.ConclusionsThere is low quality evidence to suggest that psychotherapy and pharmacotherapy may be effective interventions in the treatment of anxiety after stroke based on underpowered studies that carried high risk of bias. Large-scale well-designed definitive trials are needed to establish whether pharmacological or psychotherapy works. Our review highlighted key considerations for investigators wishing to design high quality trials to evaluate treatments for anxiety after stroke.

Original publication




Journal article


Journal of psychosomatic research

Publication Date





65 - 75


Centre for Clinical Brain Sciences, University of Edinburgh, United Kingdom. Electronic address:


Humans, Brain Injuries, Treatment Outcome, Anxiety, Psychotherapy, Clinical Trials as Topic, Stroke