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

Abstract 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.