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

'Managing the mental state' to tackle anxiety-related freezing of gait in people with Parkinson's disease: a randomized controlled intervention trial - TACKLING-FOG

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56264

Enrollment

Registered

2023-08-29

Start date

2024-03-18

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's

Interventions

The intervention consists of four sessions of a *managing the mental state* intervention, of which the first and second session will take place in the home-setting of the patient

the two remaining sessions will take place remotely. The sessions include psychoeducation on what anxiety is and how stress and anxiety can influence FOG, identifying how people are allocating atte

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Men/women of age > 18 years with idiopathic Parkinson*s disease, as diagnosed by the UK Brain Bank Criteria. -Presence of daily FOG (as objectified with the new-freezing of gait questionnaire), that is related to anxiety (positive answer to the question: Does FOG occur -or get worse- when you are anxious or stressed?). -Written informed consent.

Exclusion criteria

Exclusion criteria: -Any comorbidity (i.e. neurological, orthopedic) that significantly impacts gait. -Severe cognitive impairment hampering the ability to comply to the study protocol.

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is the percentage of freezing of gait, annotated from video recordings during a personalized walking course in the home environment.	—

Secondary

Measure	Time frame
Secondary outcomes involve the perceived levels of anxiety, and the percentage of time frozen during a home-based gait task within a participant self-selected FOG ‘hotspot’ in the home setting and during a standardized FOG-provoking gait protocol, which includes rapid 360 degrees turning in both directions, navigating a narrow passage, and performing a cognitive (serial subtraction) dual-task to assess freezing severity. Participants will also fill in several questionnaires. Additionally, upon completion of all other measures, we will perform in-depth interviews and perform a thematic analysis on these data to evaluate patients* interpretations of the intervention material, ways in which they feel it relates/related to them, and the degree to which it was (not) effective.	—

Measure

Time frame

Secondary outcomes involve the perceived levels of anxiety, and the percentage of time frozen during a home-based gait task within a participant self-selected FOG ‘hotspot’ in the home setting and during a standardized FOG-provoking gait protocol, which includes rapid 360 degrees turning in both directions, navigating a narrow passage, and performing a cognitive (serial subtraction) dual-task to assess freezing severity. Participants will also fill in several questionnaires. Additionally, upon completion of all other measures, we will perform in-depth interviews and perform a thematic analysis on these data to evaluate patients* interpretations of the intervention material, ways in which they feel it relates/related to them, and the degree to which it was (not) effective.

—

Countries

Netherlands

Contacts

Public ContactG Vissers

Radboud Universitair Medisch Centrum

gijs.vissers@radboudumc.nl0636550666

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 17, 2026