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

NCT ID: NCT02054845

Last Updated: 2014-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-12-31

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.

Conditions

Parkinsonism, Experimental; Parkinsonism, Treatment as Usual

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Body awareness therapy

The experimental treatment: BEWARE

Group Type: EXPERIMENTAL

Body awareness therapy

Intervention Type: BEHAVIORAL

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

Treatment as Usual

The new treatment is compared to this arm: Physical therapy

Group Type: ACTIVE_COMPARATOR

Physical therapy

Intervention Type: OTHER

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.

Interventions

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

BEWARE; Treatment as usual

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parkinsonvereniging

UNKNOWN

Sponsor Role: collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

O.A. van den Heuvel

Psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

O A van den Heuvel, psychiatrist

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Locations

VU Medical Center

Amsterdam, North Holland, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 29167034 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26101038 (View on PubMed)

Related Links

http://www.parkinson-beware.nl

information on the BEWARE study

Other Identifiers

CWO/13-05E

Identifier Type: -

Identifier Source: org_study_id