Parkinsonism, Experimental Clinical Trial
— BEWAREOfficial title:
BEWARE: Body Awareness Training in the trEatment of Wearing-off Related Anxiety in Patients With paRkinson's diseasE.
| Verified date | February 2014 |
| Source | VU University Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
Objective: 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.
Study design: Randomized controlled clinical trial.
Study population: Thirty-six PD patients who experience WRA.
Intervention: Patients with PD are randomly allocated into one of two groups (n= 18 each).
One group receives the experimental 'body-awareness therapy', while the second group receives
regular group-physiotherapy (treatment as usual). Both interventions will take 6 weeks in
which 2 sessions per week with a duration of 1,5 hour will be performed.
Main study parameters/endpoints: The General Self-Efficacy Scale is the primary outcome
measure and will be assessed prior to, directly after and 18 weeks after the intervention.
| Status | Unknown status |
| Enrollment | 36 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Clinical diagnosis of idiopathic Parkinson's Disease - Experiencing Wearing-off - Experiencing anxiety (BAI > 27) Exclusion Criteria: - Dementia (MMSE < 22) - Other neurologic, orthopedic, cardiopulmonary problems that may interfere with participation |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | VU Medical Center | Amsterdam | Noord-Holland |
| Lead Sponsor | Collaborator |
|---|---|
| VU University Medical Center | Parkinsonvereniging |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Mental state | To decide whether patients have to be excluded from the study, cognitive ability is measured with the Mini Mental State Examination (MMSE) | baseline | |
| Primary | Self-efficacy | how the patients can live their lives without being controlled by their disease, measured with the General Self Efficacy Scale | Change from baseline in self-efficacy at 6 weeks | |
| Primary | Self-efficacy | how the patients can live their lives without being controlled by their disease, measured with the General Self Efficacy Scale | Change from baseline in self-efficacy at 18 weeks | |
| Secondary | Anxiety | measured with the Beck Anxiety Inventory | Change from baseline in anxiety at 6 weeks | |
| Secondary | Depression | measured with the Beck Depression Inventory | Change from baseline in depression at 6 weeks | |
| Secondary | Balance performance | measured with the One Leg Stance test | Change from baseline in balance performance at 6 weeks | |
| Secondary | comfortable walking speed | measured with the 10 Meter Walk Test | Change from baseline in walking speed at 6 weeks | |
| Secondary | Quality of life | measured with the Parkinson's Disease Questionnaire - 39 | Change from baseline in quality of life at 6 weeks | |
| Secondary | Wearing-off symptoms | Assessing wearing-off related symptoms with the Wearing-off Questionnaire - 19 | Change from baseline in wearing-off symptoms at 6 weeks | |
| Secondary | Activities of Daily Living independence | measured with the Nottingham Extended Activities of Daily Living index | Change from baseline in independence at 6 weeks | |
| Secondary | Freezing of Gait | To asses an important symptom of Parkinson's disease, we included the Freezing of Gait Questionnaire | Change from baseline in freezing of gait at 6 weeks | |
| Secondary | Anxiety | measured with the Beck Anxiety Inventory | Change from baseline in anxiety at 18 weeks | |
| Secondary | Depression | measured with the Beck Depression Inventory | Change from baseline in depression at 18 weeks | |
| Secondary | Balance performance | measured with the One Leg Stance Test | Change from baseline in balance performance at 18 weeks | |
| Secondary | Comfortable walking speed | measured with the 10 Meter Walk Test | Change from baseline in walking speed at 18 weeks | |
| Secondary | Quality of Life | measured with the Parkinson's Disease Questionnaire - 39 | Change from baseline in quality of life at 18 weeks | |
| Secondary | Wearing-off symptoms | assessing wearing-off related symptoms with the Wearing-Off Questionnaire - 19 | Change from baseline in anxiety at 6 weeks | |
| Secondary | Activities of Daily Living independence | measured with the Nottingham Extended Activities of Daily Living index | Change from baseline in independence at 18 weeks | |
| Secondary | Freezing of gait | to assess an important symptom of Parkinson's Disease, as measured by the freezing of gait questionnaire | Change from baseline in freezing of gait at 18 weeks |