‘Managing the mental state’ to tackle anxiety-related freezing of gait in people with Parkinson’s disease: a randomized controlled trial

Freezing of gait (FOG) is a debilitating symptom in Parkinson’s disease (PD), characterized by paroxysmal episodes wherein there is an inability to step effectively, despite attempting to do so. Anxiety is known to exacerbate FOG. Although anxiety-relieving compensation strategies are anecdotally reported to reduce FOG, their effectiveness awaits systematic evaluation.

In this randomized controlled trial, we evaluated a personalized, non-pharmacological intervention aimed at reducing anxiety-related FOG. Forty-one participants with PD and anxiety-related FOG were randomly assigned (1:1) to either an intervention group or a waitlist control group. The intervention consisted of four weekly sessions combining psychoeducation with tailored behavioral strategies targeting anxiety in relation to FOG.

The primary outcome was the percentage of time spent frozen during a home-based walking task designed to provoke FOG. The intervention did not reduce the time spent frozen during the walking course compared with the waitlist group. Likewise, no differences were found for most secondary outcomes.

In preplanned exploratory longitudinal analyses combining both groups, reductions in time spent frozen and improvements in several secondary outcomes were observed over time. This randomized controlled trial shows that a brief, four‑session tailored behavioral intervention did not reduce objectively measured anxiety‑related FOG compared with a waitlist control. Trial registration: ClinicalTrials.gov NCT06302309.

Registered on March 4, 2024. We thank Nephthys Kishy Lanting and Marleen van Hattem for their valuable contributions throughout this project. The study is funded by the Jacques und Gloria Gossweiler Foundation.

The funders were not involved in the development of the protocol, the execution, analysis, or interpretation of the study data. Radboud University Medical Center; Donders Institute for Brain, Cognition and Behavior; Department of Rehabilitation; Center of Expertise for Parkinson & Movement Disorders, Nijmegen, Netherlands Gijs Vissers, Anouk Tosserams & Jorik Nonnekes Anouk Tosserams, Rick C. Bloem Radboud University Medical Centre; Department of Medical Psychology, Nijmegen, Netherlands Maastricht University; Department of Psychiatry and Neuropsychology, Maastricht, Netherlands Radboud University; Donders Institute for Brain Cognition and Behavior; Centre for Cognitive Neuroimaging, Nijmegen, Netherlands University of Exeter; School of Sport and Health Sciences, Exeter, UK The authors declare no competing interests.