BEWARE: Body Awareness Training in the trEatment of Wearing-off Related Anxiety in Patients With paRkinson's diseasE.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Self-efficacy
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Body awareness therapy
The experimental treatment: BEWARE
Intervention: Body awareness therapy (Behavioral)
Treatment as Usual
The new treatment is compared to this arm: Physical therapy
Intervention: Physical therapy (Other)
Outcomes
Primary Outcomes
Self-efficacy
Time Frame: 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 Outcomes
- Comfortable walking speed(Change from baseline in walking speed at 18 weeks)
- Quality of Life(Change from baseline in quality of life at 18 weeks)
- Freezing of Gait(Change from baseline in freezing of gait at 6 weeks)
- Depression(Change from baseline in depression at 18 weeks)
- comfortable walking speed(Change from baseline in walking speed at 6 weeks)
- Anxiety(Change from baseline in anxiety at 18 weeks)
- Activities of Daily Living independence(Change from baseline in independence at 18 weeks)
- Balance performance(Change from baseline in balance performance at 18 weeks)
- Quality of life(Change from baseline in quality of life at 6 weeks)
- Wearing-off symptoms(Change from baseline in anxiety at 6 weeks)
- Freezing of gait(Change from baseline in freezing of gait at 18 weeks)
Investigators
O.A. van den Heuvel
Psychiatrist
Amsterdam UMC, location VUmc