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

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

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 Overview

• Status: Unknown
• Conditions: Parkinsonism, Experimental; Parkinsonism, Treatment as Usual
• Intervention / Treatment: Behavioral: Body awareness therapy; Other: Physical therapy

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1081 HZ
      • VU Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Body awareness therapy; The experimental treatment: BEWARE	Behavioral: Body awareness therapy; 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; Other Names: BEWARE
Active Comparator: Treatment as Usual; The new treatment is compared to this arm: Physical therapy	Other: Physical therapy; 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.; 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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Collaborators: Parkinsonvereniging
• Investigators: Principal Investigator: O A van den Heuvel, psychiatrist, Amsterdam UMC, location VUmc

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• information on the BEWARE study

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: January 30, 2014
• First Submitted That Met QC Criteria: February 3, 2014
• First Posted (Estimate): February 4, 2014

Study Record Updates

• Last Update Posted (Estimate): February 4, 2014
• Last Update Submitted That Met QC Criteria: February 3, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Physical therapy; Body awareness therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Parkinsonian Disorders
• Other Study ID Numbers: CWO/13-05E