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

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ClinicalTrials.gov Identifier: NCT02054845
Recruitment Status : Unknown
Verified February 2014 by O.A. van den Heuvel, VU University Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : February 4, 2014
Last Update Posted : February 4, 2014
Sponsor:
Collaborator:
Parkinsonvereniging
Information provided by (Responsible Party):
O.A. van den Heuvel, VU University Medical Center

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.


Condition or disease Intervention/treatment Phase
Parkinsonism, Experimental Parkinsonism, Treatment as Usual Behavioral: Body awareness therapy Other: Physical therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : January 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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:

  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




Primary Outcome Measures :
  1. Self-efficacy [ Time Frame: Change from baseline in self-efficacy at 6 weeks ]
    how the patients can live their lives without being controlled by their disease, measured with the General Self Efficacy Scale

  2. 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 Outcome Measures :
  1. Anxiety [ Time Frame: Change from baseline in anxiety at 6 weeks ]
    measured with the Beck Anxiety Inventory

  2. Depression [ Time Frame: Change from baseline in depression at 6 weeks ]
    measured with the Beck Depression Inventory

  3. Balance performance [ Time Frame: Change from baseline in balance performance at 6 weeks ]
    measured with the One Leg Stance test

  4. comfortable walking speed [ Time Frame: Change from baseline in walking speed at 6 weeks ]
    measured with the 10 Meter Walk Test

  5. Quality of life [ Time Frame: Change from baseline in quality of life at 6 weeks ]
    measured with the Parkinson's Disease Questionnaire - 39

  6. Wearing-off symptoms [ Time Frame: Change from baseline in wearing-off symptoms at 6 weeks ]
    Assessing wearing-off related symptoms with the Wearing-off Questionnaire - 19

  7. Activities of Daily Living independence [ Time Frame: Change from baseline in independence at 6 weeks ]
    measured with the Nottingham Extended Activities of Daily Living index

  8. Freezing of Gait [ Time Frame: Change from baseline in freezing of gait at 6 weeks ]
    To asses an important symptom of Parkinson's disease, we included the Freezing of Gait Questionnaire

  9. Anxiety [ Time Frame: Change from baseline in anxiety at 18 weeks ]
    measured with the Beck Anxiety Inventory

  10. Depression [ Time Frame: Change from baseline in depression at 18 weeks ]
    measured with the Beck Depression Inventory

  11. Balance performance [ Time Frame: Change from baseline in balance performance at 18 weeks ]
    measured with the One Leg Stance Test

  12. Comfortable walking speed [ Time Frame: Change from baseline in walking speed at 18 weeks ]
    measured with the 10 Meter Walk Test

  13. Quality of Life [ Time Frame: Change from baseline in quality of life at 18 weeks ]
    measured with the Parkinson's Disease Questionnaire - 39

  14. Wearing-off symptoms [ Time Frame: Change from baseline in anxiety at 6 weeks ]
    assessing wearing-off related symptoms with the Wearing-Off Questionnaire - 19

  15. Activities of Daily Living independence [ Time Frame: Change from baseline in independence at 18 weeks ]
    measured with the Nottingham Extended Activities of Daily Living index

  16. Freezing of gait [ Time Frame: Change from baseline in freezing of gait at 18 weeks ]
    to assess an important symptom of Parkinson's Disease, as measured by the freezing of gait questionnaire


Other Outcome Measures:
  1. Mental state [ Time Frame: baseline ]
    To decide whether patients have to be excluded from the study, cognitive ability is measured with the Mini Mental State Examination (MMSE)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: February 2014

Keywords provided by O.A. van den Heuvel, 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