beware-treatment is more effective than usual care
ID
Bron
Verkorte titel
Aandoening
parkinson's disease
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Valued living (Chronic Illness Acceptance Questionnaire – CIAQ
Achtergrond van het onderzoek
Rationale: Wearing-off (the re-emergence of Parkinson’s disease (PD) symptoms when the medication effect wears off) is considered to be one of the most debilitating symptoms of the disease and is expressed by interacting motor and non-motor symptoms that have reciprocal influences. This results in physical and psychological distress interfering with daily life functioning and social interaction. On-off fluctuations (including wearing-off) are eventually inescapable with prolonged use of dopamine replacement therapy (e.g. levodopa) which is considered the first-line treatment in PD. Current treatment options of wearing-off related distress are monodisciplinary and unsatisfactory.
Objective: The current study aims to investigate the effect of a multidisciplinary group intervention, as compared to usual care, on the awareness and modulation of wearing-off related distress to improve coping, mobility, mood, and quality of life.
Study design: Multicentre, observer blinded, randomized controlled clinical trial.
Study population: Ninety-two PD patients who experience wearing-off symptoms with psychological distress.
Intervention: Patients with PD are randomly allocated to one of two treatment arms (n= 46 each). Per centre approximately six groups of 5/6 patients (three for each arm) will be included. One group receives the experimental group ‘body awareness therapy’, while the other group receives regular group physiotherapy (treatment as usual). Both interventions will take 10 weeks with weekly sessions of 1,5 hour. Homework assignments will be implemented through an online workbook.
Main study parameters/endpoints: Primary outcome is the Chronic Illness Acceptance Questionnaire (CIAQ). Secondary outcome measures focus on motor and non-motor symptoms of PD, quality of life, anxiety, depression, and mobility. All outcomes will be assessed at pre- and post-treatment, and 12 weeks follow-up.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All participants will receive, and may benefit from, treatment for their wearing-off symptoms; half of them in conventional TAU and half of them the experimental BEWARE treatment. On three time points, extra time will be asked of the patients to assess the primary and secondary outcome measurements (approximately 45 minutes at home and 60 minutes on site).
Doel van het onderzoek
beware-treatment is more effective than usual care
Onderzoeksopzet
0, 10 and 22 weeks
Onderzoeksproduct en/of interventie
Body awareness training
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1) Diagnosis according to the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease (Postuma et al., 2015);
2) Hoehn and Yahr disease stages 2 - 4;
3) Experiencing wearing-off, as measured by the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale part IV (motor complications, including wearing-off);
4) Experiencing psychological distress (defined by clinical evaluation concerning avoidance and safety behaviour, anxiety symptoms (as is also assessed with the Parkinson Anxiety Scale), and restrictions in daily life due to wearing-off);
5) Stable and optimal anti-Parkinson and/or psychopharmacological medication regimen, including Deep Brain Stimulation and pump-delivered therapy, for at least six weeks prior to study participation;
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1) Unable to attend at least eight group treatment sessions (including the first and last session);
2) Currently receiving an active form of psychological treatment or physical therapy within six weeks prior to study participation. Supportive physical therapy and supportive conversations with a psychologist are allowed to be continued, as long as this is routinely incorporated for at least six weeks prior to study participation;
3) Cognitive impairment (Montreal Cognitive Assessment (MoCA) score < 24);
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7398 |
| NTR-old | NTR7606 |
| CCMO | NL64732.029.18 |
| OMON | NL-OMON50397 |