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BEWARE: Body awareness training for wearing-off related distress in Parkinson patients

BEWARE: Body awareness training for wearing-off related distress in Parkinson patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25333
Enrollment
92
Registered
2018-09-10
Start date
2018-06-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

parkinson's disease

Interventions

Body awareness training

Sponsors

VUmc
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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;

Exclusion criteria

Exclusion criteria: 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);

Design outcomes

Primary

MeasureTime frame
Valued living (Chronic Illness Acceptance Questionnaire – CIAQ

Secondary

MeasureTime frame
- Mobility (10 Meter Walk Test, One Leg Stance Test, and new Freezing of Gait Questionnaire - Activities of daily living (Nottingham Extended Activities of Daily Living Index with domains mobility, kitchen, household, and leisure activities); - Anxiety and depression using the Parkinson Anxiety Scale and the Beck Depression Inventory; - Body awareness (Body Awareness Questionnaire); - Quality of Life (eight-item Parkinson’s Disease Questionnaire) ; - Caregiver burden (Caregiver Strain Index). - Wearing-off symptoms measured with the 10-item Wearing-Off Questionnaire 6.1.3 Other study parameters - Cognition represented by the MoCA score ; - Coping style measured with the Coping Inventory of Stressful Situations (CISS-21) ; - Disease severity measured with the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (motor examination), IV (motor complications, including wearing-off), and V (Hoehn & Yahr stage) in optimal ‘on’; - Duration of illness (since diagnosis); - Medication schedule and usage (dopaminergic and psychopharmacological); - The time spent on homework assignments (available through the online platform).

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)