BEWARE: Body Awareness Training in the trEatment of Wearing-off Related Anxiety in Patients With paRkinson's Disease

Study Overview
=================
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.

Official Title
-----------------
BEWARE: Body Awareness Training in the trEatment of Wearing-off Related Anxiety in Patients With paRkinson's diseasE.

Conditions
-----------------
Parkinsonism, Experimental, Parkinsonism, Treatment as Usual

Intervention / Treatment
-----------------
* Behavioral: Body awareness therapy
* Other: Physical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Body awareness therapy<br>The experimental treatment: BEWARE | Behavioral: Body awareness therapy<br>* Experimental condition: BEWARE training group The physical and psychosocial elements of the training sessions will be complementary: psychological techniques are used to induce and endure wearing-off and physical techniques are used to improve body awareness to cope with the off-periods. Specifically the following techniques will be applied: Body scan Psychoeducation Acceptance Commitment Therapy / Mindfulness skills (sustained attention, concentration, non-reactivity, nonjudging of experience) Body Awareness Training Exposure training (imaginary exposure to induce response fluctuations) Training in cueing techniques to overcome problems with initiation and freezing Visual Feedback training Relaxation techniques<br>* Other names: BEWARE;|
| Active Comparator: Treatment as Usual<br>The new treatment is compared to this arm: Physical therapy | Other: Physical therapy<br>* Control condition: Treatment as Usual The control group will receive treatment as usual based on the current guidelines for physical therapy in patients with Parkinson's Disease, with the same training schedule of 2x per week for 1,5 hours during 6 weeks. Group treatment will contain exercises for balance, walking, posture, transfers, arm/hand dexterity, strength, flexibility, relaxation and physical condition.<br>* Other names: Treatment as usual;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | measured with the Beck Anxiety Inventory | Change from baseline in anxiety at 6 weeks | 
| Depression | measured with the Beck Depression Inventory | Change from baseline in depression at 6 weeks | 
| Balance performance | measured with the One Leg Stance test | Change from baseline in balance performance at 6 weeks | 
| comfortable walking speed | measured with the 10 Meter Walk Test | Change from baseline in walking speed at 6 weeks | 
| Quality of life | measured with the Parkinson's Disease Questionnaire - 39 | Change from baseline in quality of life at 6 weeks | 
| Wearing-off symptoms | Assessing wearing-off related symptoms with the Wearing-off Questionnaire - 19 | Change from baseline in wearing-off symptoms at 6 weeks | 
| Activities of Daily Living independence | measured with the Nottingham Extended Activities of Daily Living index | Change from baseline in independence at 6 weeks | 
| 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 | 
| Anxiety | measured with the Beck Anxiety Inventory | Change from baseline in anxiety at 18 weeks | 
| Depression | measured with the Beck Depression Inventory | Change from baseline in depression at 18 weeks | 
| Balance performance | measured with the One Leg Stance Test | Change from baseline in balance performance at 18 weeks | 
| Comfortable walking speed | measured with the 10 Meter Walk Test | Change from baseline in walking speed at 18 weeks | 
| Quality of Life | measured with the Parkinson's Disease Questionnaire - 39 | Change from baseline in quality of life at 18 weeks | 
| Wearing-off symptoms | assessing wearing-off related symptoms with the Wearing-Off Questionnaire - 19 | Change from baseline in anxiety at 6 weeks | 
| Activities of Daily Living independence | measured with the Nottingham Extended Activities of Daily Living index | Change from baseline in independence at 18 weeks | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Body awareness therapy, Physical therapy