In this project we aim to evaluate whether a non-pharmacological and tailored intervention targeting anxiety- and stress-related FOG in people with PD is effective to reduce the impact of anxiety and stress on FOG. Specifically, we aim to study: (1…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the subjective impact of anxiety and stress on
FOG, as measured with a 7-point Likert scale.
Secondary outcome
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.
Background summary
Freezing of Gait (FOG) is a common and disabling symptom in people with
Parkinson*s Disease (PD), characterized by paroxysmal episodes where there is
an inability to step effectively, despite attempting to do so. Treatment
consists of complementary pharmacological and non-pharmacological treatment
options which unfortunately only partially alleviate FOG. Anxiety has been
found to contribute to the occurrence and exacerbation of FOG, which often
manifests itself in situations where people with FOG anticipate not being in
control of their movements. People with FOG are often aware of the feelings and
situations that elicit FOG episodes, but they rarely actively employ strategies
targeting their mental state to improve FOG. With the exception of general
interventions including mindfulness, yoga and meditation, tailored strategies
to ameliorate anxiety-related FOG have never been evaluated in a systematic
manner.
Study objective
In this project we aim to evaluate whether a non-pharmacological and tailored
intervention targeting anxiety- and stress-related FOG in people with PD is
effective to reduce the impact of anxiety and stress on FOG. Specifically, we
aim to study: (1) the effect of four sessions of a *managing the mental state*
intervention in people with disabling and anxiety-related FOG; and (2) the key
determinants of the effectiveness of the intervention to reduce the impact of
anxiety and stress on FOG.
Study design
This study is a randomized controlled trial (RCT). The intervention group will
receive the intervention immediately after randomization while a (waitlist)
control group receives the same intervention thereafter.
Intervention
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
attention and engage in specific thought-processes (e.g. worrisome thoughts)
during walking, and educating patients about *managing the mental state*
compensation strategies that involve ways to reduce anxiety or stress and will
be specifically tailored to the individual patient.
Study burden and risks
Benefit: We expect responders to benefit from the intervention by reducing
anxiety- and stress-related FOG.
Burden: The risk associated with participation will be negligible.
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Listed location countries
Age
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
-Any comorbidity (i.e. neurological, orthopedic) that significantly impacts
gait.
-Severe cognitive impairment hampering the ability to comply to the study
protocol.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85217.091.23 |