BEWARE 2.0: body awareness training for wearing-off related distress in Parkinson's disease patients

About 75% of Parkinson*s disease (PD) patients with motor fluctuations,
including wearing-off (the re-emergence of PD symptoms when the medication
effect wears off), experience very disabling mood, anxiety and/or cognitive
fluctuations in parallel. The wearing-off phenomenon in PD patients is
accompanied by both motor and non-motor (autonomic, cognitive and emotional)
symptoms, resulting in physical and psychological distress interfering with
daily functioning and social interaction. Wearing-off is considered the one of
the most troublesome symptoms of PD. The impact of the physical symptoms
accompanying wearing-off on daily life functioning is often higher than can be
explained from the actual severity of the motor symptoms, resulting in severe
wearing-off related distress (WRD) and suggesting a deviating body awareness.
The reciprocal interactions between motor, autonomic and psychological features
of wearing-off seem to underlie the negative vicious circle that often results.
Besides predictable medication-related wearing-off, unpredictability of the
reoccurrence of PD symptoms has been described by individuals as a primary
concern affecting participation in daily life. Current treatment options are
very limited and typically focus on either the physical or psychological
aspects of PD fluctuations. Optimizing dopaminergic therapy can improve both
types of fluctuations to some extent. However, as the disease progresses these
pharmacological options become insufficient and have downsides or side effects
(such as the development of dopamine dysregulation syndrome, hallucinations or
impulse control disorders). In line with this evidence, the Parkinson Patient
Association (Parkinson Vereniging) investigated research priorities in the PD
population. Within the non-motor domain, coping was considered most important
to study. In addition, it was argued that when one learns to cope with the
disease, this reduces distress and avoidance of daily activities. The primary
focus of BEWARE is to teach PD patients to cope with the fluctuations of the
disease and by this to improve valued living. In an already conducted phase II
pilot randomized controlled trial, it has been shown that PD patients that
received the BEWARE training improve in their emotional wellbeing, as well as
in their balance and trend-wise in feeling less stigmatized about their
disease.

Do patients that receive the BEWARE training have a higher score on the Chronic
Illness Acceptance Questionnaire at the end of treatment (and at 3 month
follow-up) compared to the treatment as usual (physical therapy only)?

This will be an observer-blinded multicenter randomized controlled trial.

The BEWARE training primarily focuses on living a valuable life despite the
presence of motor and non-motor wearing-off. This is achieved by combining
Acceptance and Commitment Therapy (ACT) with physical therapy. Treatment will
be delivered by a team consisting of a psychotherapist trained in ACT and a
physical therapist trained in PD treatment guidelines.
The intervention consists of the following elements:
1) Psycho-education about PD and wearing-off, including the motor and non-motor
symptoms and their reciprocal interactions. This information will also be
delivered to the caregiver/partner of the patients;
2) Explanation on and training of in the concepts of body awareness,
self-recognition, cognitive defusion, and valued living. This will be combined
with imaginary exposure, in ACT therapy known as FEEL (Feeling Experiences
Enriches Living) exercises. The patients will practice with experiencing and
daring to allow the feelings that are triggered by the *off* during this
imaginary exposure. The patients are gradually encouraged to take part in
activities that they previously avoided because of the (anticipation of)
wearing-off;
3) Physical exercises that are alternated with the psychological exercises.
These exercises include mobility and body awareness strategies to initiate
movement when the patient finds him/herself in an *off*, body-scan exercises,
moving on rhythms and music helping the patient to consciously experience
physical movement and relieve stress after the imaginary exposure.
4) Finally, to generalize the intended treatment effect to daily life
functioning, the patients are given homework assignments, including body
awareness exercises and planning of value-based committed actions in their
daily lives. Help with these assignments will consist of an online, web-based
workbook with audio and video instructions. These homework assignments will
also encourage the active involvement of the caregiver/partner of the patient
and a prolonged retention of the learned skills. The homework assignments shall
be monitored to take the amount of time practicing into account in the
analyses. A prolonged retention is also achieved by relapse prevention, which
is the focus of the last therapy session.
The BEWARE training will be compared with TAU, e.g. physical therapy focussed
on improving mobility related to transfers, posture, balance instability and
gait, according to the current European guidelines from the Royal Dutch
Physical Therapy Society. Elements 3 & 4 of the BEWARE training will also be
implemented in the TAU. However, the homework assignments in the TAU group will
solely focus on physical therapy exercises by using the *Parkinson exercise
app*, as is in line with European guidelines.

Risks are considered negligible.
All participants will receive, and may benefit from, treatment for their
wearing-off symptoms; half of them in conventional TAU and half of them the
experimental BEWARE treatment. They are asked to maintain their medication
schedule, and are expected to do homework assignments.
On three time points, extra time will be asked of the patients to assess the
primary and secondary outcome measurements (approximately 45 minutes at home
and 60 minutes on site).