Parkinsonism, ExperimentalBEWARENCT02054845
BEWARE: Body Awareness Training in the trEatment of Wearing-off Related Anxiety in Patients With paRkinson's Disease
A study testing Body awareness therapy and Physical therapy in people with Parkinsonism, Experimental and Parkinsonism, Treatment as Usual, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinsonism, Experimental, Parkinsonism, Treatment as Usual
- What is being tested?
- Body awareness therapy and Physical therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of idiopathic Parkinson's Disease
- Experiencing Wearing-off
- Experiencing anxiety (BAI > 27)
Who cannot join
- Dementia (MMSE < 22)
- Other neurologic, orthopedic, cardiopulmonary problems that may interfere with participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- Body awareness therapy, Physical therapy
- Keywords
- Body awareness therapy, Physical therapy
- Medical subject headings
- Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body awareness therapyBehavioural
Also called BEWARE
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
Physical therapyOther
Also called Treatment as usual
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.
| Study group | Role | What they receive |
|---|---|---|
| Body awareness therapy | Experimental | The experimental treatment: BEWARE Receives: Behavioral: Body awareness therapy |
| Treatment as Usual | Active comparator | The new treatment is compared to this arm: Physical therapy Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy
how the patients can live their lives without being controlled by their disease, measured with the General Self Efficacy Scale
Measured: 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
Measured: Change from baseline in self-efficacy at 18 weeks
Secondary outcomes (16)
Anxiety
measured with the Beck Anxiety Inventory
Measured: Change from baseline in anxiety at 6 weeks
Depression
measured with the Beck Depression Inventory
Measured: Change from baseline in depression at 6 weeks
Balance performance
measured with the One Leg Stance test
Measured: Change from baseline in balance performance at 6 weeks
comfortable walking speed
measured with the 10 Meter Walk Test
Measured: Change from baseline in walking speed at 6 weeks
Quality of life
measured with the Parkinson's Disease Questionnaire - 39
Measured: Change from baseline in quality of life at 6 weeks
Wearing-off symptoms
Assessing wearing-off related symptoms with the Wearing-off Questionnaire - 19
Measured: 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
Measured: 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
Measured: Change from baseline in freezing of gait at 6 weeks
Anxiety
measured with the Beck Anxiety Inventory
Measured: Change from baseline in anxiety at 18 weeks
Depression
measured with the Beck Depression Inventory
Measured: Change from baseline in depression at 18 weeks
Balance performance
measured with the One Leg Stance Test
Measured: Change from baseline in balance performance at 18 weeks
Comfortable walking speed
measured with the 10 Meter Walk Test
Measured: Change from baseline in walking speed at 18 weeks
Quality of Life
measured with the Parkinson's Disease Questionnaire - 39
Measured: Change from baseline in quality of life at 18 weeks
Wearing-off symptoms
assessing wearing-off related symptoms with the Wearing-Off Questionnaire - 19
Measured: Change from baseline in anxiety at 6 weeks
Activities of Daily Living independence
measured with the Nottingham Extended Activities of Daily Living index
Measured: 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
Measured: Change from baseline in freezing of gait at 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinsonism, ExperimentalStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Parkinsonvereniging
- Responsible party
- Principal investigator, O.A. van den Heuvel, Amsterdam UMC, location VUmc
- Investigators
- O A van den Heuvel, psychiatrist, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054845
- Sponsor's protocol ID
- CWO/13-05E
- Acronym
- BEWARE
- Status last verified
- Feb 2014
- First submitted
- 30 Jan 2014
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 29167034Ghielen 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.
PubMed 26101038
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEWARE: Body Awareness Training in the trEatment of Wearing-off Related Anxiety in Patients With paRkinson's diseasE.
- ClinicalTrials.gov ID
- NCT02054845
- Acronym / sponsor ID
- BEWARE / CWO/13-05E
- Keywords
- Body awareness therapy, Physical therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Parkinsonvereniging
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body awareness therapy | Experimental | Behavioral: Body awareness therapyThe experimental treatment: BEWARE |
| Treatment as Usual | Active comparator | Other: Physical therapyThe new treatment is compared to this arm: Physical therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of idiopathic Parkinson's Disease
- Experiencing Wearing-off
- Experiencing anxiety (BAI > 27)
Key exclusion criteria (2 listed)
- Dementia (MMSE < 22)
- Other neurologic, orthopedic, cardiopulmonary problems that may interfere with participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body awareness therapyAlso: BEWAREExperimental 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 | Behavioural | Body awareness therapy |
| Physical therapyAlso: Treatment as usualControl 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 | Treatment as Usual |
Primary outcome
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
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
16 secondary outcomes
Anxiety
Time frame: Change from baseline in anxiety at 6 weeks
Depression
Time frame: Change from baseline in depression at 6 weeks
Balance performance
Time frame: Change from baseline in balance performance at 6 weeks
comfortable walking speed
Time frame: Change from baseline in walking speed at 6 weeks
Quality of life
Time frame: Change from baseline in quality of life at 6 weeks
Wearing-off symptoms
Time frame: Change from baseline in wearing-off symptoms at 6 weeks
Activities of Daily Living independence
Time frame: Change from baseline in independence at 6 weeks
Freezing of Gait
Time frame: Change from baseline in freezing of gait at 6 weeks
Anxiety
Time frame: Change from baseline in anxiety at 18 weeks
Depression
Time frame: Change from baseline in depression at 18 weeks
Balance performance
Time frame: Change from baseline in balance performance at 18 weeks
Comfortable walking speed
Time frame: Change from baseline in walking speed at 18 weeks
Quality of Life
Time frame: Change from baseline in quality of life at 18 weeks
Wearing-off symptoms
Time frame: Change from baseline in anxiety at 6 weeks
Activities of Daily Living independence
Time frame: Change from baseline in independence at 18 weeks
Freezing of gait
Time frame: Change from baseline in freezing of gait at 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
- Derived from this study: PubMed 29167034Ghielen 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.
- Derived from this study: PubMed 26101038Ghielen 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.
- information on the BEWARE studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
O A van den Heuvel, psychiatrist principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body awareness therapy and Physical therapy in people with Parkinsonism, Experimental and Parkinsonism, Treatment as Usual, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy (time frame: Change from baseline in self-efficacy at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02054845, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2014.