Clinical trial NCT02054845: BEWARE: Body Awareness Training in the trEatment of Wearing-off Related Anxiety in Patients With paRkinson's Disease
Official title: BEWARE: Body Awareness Training in the trEatment of Wearing-off Related Anxiety in Patients With paRkinson's diseasE.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinsonism, Experimental
Parkinsonism, Treatment as Usual
Keywords: Body awareness therapy
Physical therapy
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Parkinsonvereniging
First posted: 2014-02-04
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Self-efficacy
timeFrame: Change from baseline in self-efficacy at 6 weeks
measure: Self-efficacy
timeFrame: Change from baseline in self-efficacy at 18 weeks
Secondary outcomes:
measure: Anxiety
timeFrame: Change from baseline in anxiety at 6 weeks
measure: Depression
timeFrame: Change from baseline in depression at 6 weeks
measure: Balance performance
timeFrame: Change from baseline in balance performance at 6 weeks
measure: comfortable walking speed
timeFrame: Change from baseline in walking speed at 6 weeks
measure: Quality of life
timeFrame: Change from baseline in quality of life at 6 weeks
measure: Wearing-off symptoms
timeFrame: Change from baseline in wearing-off symptoms at 6 weeks
measure: Activities of Daily Living independence
timeFrame: Change from baseline in independence at 6 weeks
measure: Freezing of Gait
timeFrame: Change from baseline in freezing of gait at 6 weeks
measure: Anxiety
timeFrame: Change from baseline in anxiety at 18 weeks
measure: Depression
timeFrame: Change from baseline in depression at 18 weeks
measure: Balance performance
timeFrame: Change from baseline in balance performance at 18 weeks
measure: Comfortable walking speed
timeFrame: Change from baseline in walking speed at 18 weeks
measure: Quality of Life
timeFrame: Change from baseline in quality of life at 18 weeks
measure: Wearing-off symptoms
timeFrame: Change from baseline in anxiety at 6 weeks
measure: Activities of Daily Living independence
timeFrame: Change from baseline in independence at 18 weeks
measure: Freezing of gait
timeFrame: Change from baseline in freezing of gait at 18 weeks
Other outcomes:
measure: Mental state
timeFrame: baseline
Locations:
city: Amsterdam
country: Netherlands
facility: VU Medical Center
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: O A van den Heuvel, psychiatrist
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.