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| Name | Class |
|---|---|
| Parkinsonvereniging | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Body awareness therapy | Experimental | The experimental treatment: BEWARE |
|
| Treatment as Usual | Active Comparator | The new treatment is compared to this arm: Physical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Body awareness therapy | Behavioral | 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:
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| O A van den Heuvel, psychiatrist | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VU Medical Center | Amsterdam | North Holland | 1081 HZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29167034 | Derived | Ghielen I, van Wegen EEH, Rutten S, de Goede CJT, Houniet-de Gier M, Collette EH, Burgers-Bots IAL, Twisk JWR, Kwakkel G, Vermunt K, van Vliet B, Berendse HW, van den Heuvel OA. Body awareness training in the treatment of wearing-off related anxiety in patients with Parkinson's disease: Results from a pilot randomized controlled trial. J Psychosom Res. 2017 Dec;103:1-8. doi: 10.1016/j.jpsychores.2017.09.008. Epub 2017 Sep 21. | |
| 26101038 |
| Label | URL |
|---|---|
| information on the BEWARE study | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 11, 2017 | |
| Reset | Oct 3, 2017 |
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|
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| Physical therapy | Other | 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. |
|
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| 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 |
| Derived |
| Ghielen I, van den Heuvel OA, de Goede CJ, Houniet-de Gier M, Collette EH, Burgers-Bots IA, Rutten S, Kwakkel G, Vermunt K, van Vliet B, Berendse HW, van Wegen EE. BEWARE: Body awareness training in the treatment of wearing-off related anxiety in patients with Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2015 Jun 23;16:283. doi: 10.1186/s13063-015-0804-0. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 11, 2017 | Oct 3, 2017 |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
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