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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Parkinsonvereniging
Information provided by (Responsible Party):
O.A. van den Heuvel, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT02054845
First received: January 30, 2014
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Parkinsonism, Experimental
Parkinsonism, Treatment as Usual
Behavioral: Body awareness therapy
Other: Physical therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BEWARE: Body Awareness Training in the trEatment of Wearing-off Related Anxiety in Patients With paRkinson's diseasE.

Resource links provided by NLM:


Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • Self-efficacy [ Time Frame: Change from baseline in self-efficacy at 6 weeks ] [ Designated as safety issue: No ]
    how the patients can live their lives without being controlled by their disease, measured with the General Self Efficacy Scale

  • Self-efficacy [ Time Frame: Change from baseline in self-efficacy at 18 weeks ] [ Designated as safety issue: No ]
    how the patients can live their lives without being controlled by their disease, measured with the General Self Efficacy Scale


Secondary Outcome Measures:
  • Anxiety [ Time Frame: Change from baseline in anxiety at 6 weeks ] [ Designated as safety issue: No ]
    measured with the Beck Anxiety Inventory

  • Depression [ Time Frame: Change from baseline in depression at 6 weeks ] [ Designated as safety issue: No ]
    measured with the Beck Depression Inventory

  • Balance performance [ Time Frame: Change from baseline in balance performance at 6 weeks ] [ Designated as safety issue: No ]
    measured with the One Leg Stance test

  • comfortable walking speed [ Time Frame: Change from baseline in walking speed at 6 weeks ] [ Designated as safety issue: No ]
    measured with the 10 Meter Walk Test

  • Quality of life [ Time Frame: Change from baseline in quality of life at 6 weeks ] [ Designated as safety issue: No ]
    measured with the Parkinson's Disease Questionnaire - 39

  • Wearing-off symptoms [ Time Frame: Change from baseline in wearing-off symptoms at 6 weeks ] [ Designated as safety issue: No ]
    Assessing wearing-off related symptoms with the Wearing-off Questionnaire - 19

  • Activities of Daily Living independence [ Time Frame: Change from baseline in independence at 6 weeks ] [ Designated as safety issue: No ]
    measured with the Nottingham Extended Activities of Daily Living index

  • Freezing of Gait [ Time Frame: Change from baseline in freezing of gait at 6 weeks ] [ Designated as safety issue: No ]
    To asses an important symptom of Parkinson's disease, we included the Freezing of Gait Questionnaire

  • Anxiety [ Time Frame: Change from baseline in anxiety at 18 weeks ] [ Designated as safety issue: No ]
    measured with the Beck Anxiety Inventory

  • Depression [ Time Frame: Change from baseline in depression at 18 weeks ] [ Designated as safety issue: No ]
    measured with the Beck Depression Inventory

  • Balance performance [ Time Frame: Change from baseline in balance performance at 18 weeks ] [ Designated as safety issue: No ]
    measured with the One Leg Stance Test

  • Comfortable walking speed [ Time Frame: Change from baseline in walking speed at 18 weeks ] [ Designated as safety issue: No ]
    measured with the 10 Meter Walk Test

  • Quality of Life [ Time Frame: Change from baseline in quality of life at 18 weeks ] [ Designated as safety issue: No ]
    measured with the Parkinson's Disease Questionnaire - 39

  • Wearing-off symptoms [ Time Frame: Change from baseline in anxiety at 6 weeks ] [ Designated as safety issue: No ]
    assessing wearing-off related symptoms with the Wearing-Off Questionnaire - 19

  • Activities of Daily Living independence [ Time Frame: Change from baseline in independence at 18 weeks ] [ Designated as safety issue: No ]
    measured with the Nottingham Extended Activities of Daily Living index

  • Freezing of gait [ Time Frame: Change from baseline in freezing of gait at 18 weeks ] [ Designated as safety issue: No ]
    to assess an important symptom of Parkinson's Disease, as measured by the freezing of gait questionnaire


Other Outcome Measures:
  • Mental state [ Time Frame: baseline ] [ Designated as safety issue: No ]
    To decide whether patients have to be excluded from the study, cognitive ability is measured with the Mini Mental State Examination (MMSE)


Enrollment: 36
Study Start Date: January 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:

  1. Body scan
  2. Psychoeducation
  3. Acceptance Commitment Therapy / Mindfulness skills (sustained attention, concentration, non-reactivity, nonjudging of experience)
  4. Body Awareness Training
  5. Exposure training (imaginary exposure to induce response fluctuations)
  6. Training in cueing techniques to overcome problems with initiation and freezing
  7. Visual Feedback training
  8. Relaxation techniques
Other Name: 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 Name: Treatment as usual

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02054845

Locations
Netherlands
VU Medical Center
Amsterdam, Noord-Holland, Netherlands, 1081 HZ
Sponsors and Collaborators
VU University Medical Center
Parkinsonvereniging
Investigators
Principal Investigator: O A van den Heuvel, psychiatrist VU University Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: O.A. van den Heuvel, Psychiatrist, VU University Medical Center
ClinicalTrials.gov Identifier: NCT02054845     History of Changes
Other Study ID Numbers: CWO/13-05E
Study First Received: January 30, 2014
Last Updated: February 3, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by VU University Medical Center:
Body awareness therapy
Physical therapy

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on September 18, 2014