BEWARE: Body Awareness Training in the trEatment of Wearing-off Related Anxiety in Patients With paRkinson's Disease
- Conditions
- Parkinsonism, ExperimentalParkinsonism, Treatment as Usual
- Interventions
- Behavioral: Body awareness therapyOther: Physical therapy
- Registration Number
- NCT02054845
- Lead Sponsor
- Amsterdam UMC, location VUmc
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
- Clinical diagnosis of idiopathic Parkinson's Disease
- Experiencing Wearing-off
- Experiencing anxiety (BAI > 27)
- Dementia (MMSE < 22)
- Other neurologic, orthopedic, cardiopulmonary problems that may interfere with participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Body awareness therapy Body awareness therapy The experimental treatment: BEWARE Treatment as Usual Physical therapy The new treatment is compared to this arm: Physical therapy
- Primary Outcome Measures
Name Time Method Self-efficacy Change from baseline in self-efficacy at 18 weeks how the patients can live their lives without being controlled by their disease, measured with the General Self Efficacy Scale
- Secondary Outcome Measures
Name Time Method Comfortable walking speed Change from baseline in walking speed at 18 weeks measured with the 10 Meter Walk Test
Quality of Life Change from baseline in quality of life at 18 weeks measured with the Parkinson's Disease Questionnaire - 39
Depression Change from baseline in depression at 18 weeks measured with the Beck Depression Inventory
comfortable walking speed Change from baseline in walking speed at 6 weeks measured with the 10 Meter Walk Test
Freezing of Gait Change from baseline in freezing of gait at 6 weeks To asses an important symptom of Parkinson's disease, we included the Freezing of Gait Questionnaire
Anxiety Change from baseline in anxiety at 18 weeks measured with the Beck Anxiety Inventory
Activities of Daily Living independence Change from baseline in independence at 18 weeks measured with the Nottingham Extended Activities of Daily Living index
Balance performance Change from baseline in balance performance at 18 weeks measured with the One Leg Stance Test
Quality of life Change from baseline in quality of life at 6 weeks measured with the Parkinson's Disease Questionnaire - 39
Wearing-off symptoms Change from baseline in anxiety at 6 weeks assessing wearing-off related symptoms with the Wearing-Off Questionnaire - 19
Freezing of gait Change from baseline in freezing of gait at 18 weeks to assess an important symptom of Parkinson's Disease, as measured by the freezing of gait questionnaire
Trial Locations
- Locations (1)
VU Medical Center
🇳🇱Amsterdam, Noord-Holland, Netherlands