Body awareness training in the trEatment of Wearing-off related Anxiety in patients with paRkinson*s diseasE.

Approximately 60% of the patients with Parkinson*s Disease (PD) that receive
Levodopa therapy eventually develop response fluctuations in motor symptoms,
such as rigidity, freezing and akinesia. Patients experience an *off*-period
just before the next dose of dopaminergic medication is needed, called the
*wearing-off*-phenomena. Wearing-off is also accompanied by non-motor symptoms
such as depression, anxiety, pain and thinking disability. Together, these
motor and non-motor symptoms have a major impact on the quality of life of
patients and their partner or caregiver.
Patients with wearing-off often experience severe anxiety and panic symptoms
that are incongruent with the severity of the motor symptoms during an *off*
period. These symptoms include stress, dizziness, pounding/racing of the heart,
dyspnoea and hyperventilation. This type of anxiety is called wearing-off
related anxiety (WRA) and might be a consequence of the hypersensitivity
towards somatic manifestations and effects of a wearing-off period. This bodily
misperception can have major consequences for the patient*s feelings and
behaviour. The experienced anxiety is often not consciously linked to the
wearing-off and is therefore not well recognized by neurologists.
Treatment as usual in response fluctuations is physiotherapy, consisting of
physical exercises for mobility problems, freezing, dyskinesias, etc. This kind
of training hardly touches upon the mental aspects and the role of anxiety as
integral element of the response fluctuations. Cognitive behaviour therapy
(CBT, including exposure in vivo) is sometimes used to treat WRA, but seems to
have unsatisfactory results since the changed body awareness is not
sufficiently addressed. Also, the methods used in cognitive therapies focus on
the elimination of WRA which is often not realistic since wearing-off symptoms
will remain or even increase during disease progression. As of yet, there are
no known alternative intervention options. This study focuses on a new
intervention by integrating elements from physiotherapy, mindfulness, CBT
(mainly exposure), Acceptance and Commitment Therapy (ACT) and
psycho-education.

The current proposal aims at investigating the effect of a multidisciplinary
non-verbal intervention on the awareness and modulation of WRA to improve
self-efficacy, mobility, mood, and quality of life as compared to usual care.

This is a randomized controlled clinical trial.
Patients with Parkinson*s disease (n=48) that experience wearing-off related
anxiety will be randomly allocated to either the BEWARE training group (n=24)
or to a control group receiving usual care (n=24) using permuted blocks of 6
with concealed opaque envelopes. Randomization will be performed by an
independent person not involved in the study. Both groups will be asked to
maintain the regular medication schedule. Assessments will be conducted prior
to intervention, at 6 weeks directly after intervention and at 18 weeks follow
up.

Patients with PD are randomly allocated into one of two groups (n= 24 each).
One group receiviesthe experimental *body-awareness therapy*, while the second
group receives regular group-physiotherapy (treatment as usual). The
experimental condition addresses elements and techniques from mindfulness
training, physical therapy, exposure/flooding therapy and psychoeducation. One
home-based therapy session together with a caregiver or partner will also be
part of the intervention and will be scheduled between the third and fourth
group training session. Also, the patients are given homework assignments to
generalize treatment outcomes to their daily lives.

The PD patients will receive treatment for their WRA. On three time points,
extra time will be asked of the patients to perform the primary and secondary
outcome measurements.