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A strategic executive treatment for executive dysfunction in patients with Parkinson’s disease

The efficacy of ReSET, a Strategic Executive Treatment for executive dysfunction in patients with Parkinson’s disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13595005
Enrollment
90
Registered
2016-11-04
Start date
2011-08-03
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Parkinson's disease Nervous System Diseases Parkinson disease

Interventions

Patients are blindly allocated to the following two groups by drawing lots. In order to balance the allocation of patients to both treatment conditions, lots are drawn per 4 patients (i.e. 2 experimen
goal setting and planning
and initiative and regulation. Patients are taught several strategies that can be applied to a broad range of daily life situations. 2. Control treatment - Cogniplus: computerized cogn

Sponsors

Dutch Organization for Scientific Research (NWO), the National Initiative Brain and Cognition (NIHC)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with idiopathic Parkinson's disease according to the UK Parkinson’s Disease Brain Bank Criteria, with disease severity = Hoehn & Yahr (H&Y) stage 3 2. Age range 18-80 years 3. Patients had to be motivated for treatment 4. Patients had to report problems with EF in daily life that were experienced as burdensome (based on semi-structured interview and/or a total score of =18 on the Dysexecutive Questionnaire (DEX) and/or showed impairments on objective neuropsychological tests of executive function (EF): 4.1. A standard score of =2 on the subtests Zoo Map Test or Six Elements Test of the Behavioural Assessment of the Dysexecutive Syndrome (BADS) and/or 4.2. A standard age total score on the BADS categorized as “low average” or lower and/or 4.3. A discrepancy of 15 points between standard age score and premorbid IQ as measured with the short version of the Dutch Groninger Intelligence Test 5. Patients had to speak and understand the Dutch language

Exclusion criteria

Exclusion criteria: 1. Severe neurological comorbidity, such as traumatic brain injury or stroke 2. Severe psychiatric symptoms, such as hallucinations, delusions or depression 3. Severe cognitive comorbidity: e.g. amnestic syndrome, global aphasia, neglect, severe memory problems, PD dementia (i.e. SCales for Outcomes in PArkinson’s disease-COGnition scale score =17) 4. Hoehn & Yahr stage 4 and 5

Design outcomes

Primary

MeasureTime frame
Patients’ level of participation in different societal domains (i.e. work, social relations, leisure activities and mobility), measured using the Role Resumption list (RRL) at baseline, two weeks post-treatment and at 3-5 months follow-up

Secondary

MeasureTime frame
Measured at baseline, 2 weeks post-treatment and at 3-5 months follow-up: 1. Attainment of three individual executive goals set by patients during the third session of ReSET or Cogniplus, measured using the Treatment Goal Attainment scale 2. Problems in executive functioning in daily life, measured using the Dysexecutive Questionnaire, completed by participants and someone who had a good insight into the patients’ functioning in daily life 3. Quality of life, measured using the Parkinson's Disease Questionnaire (PDQ-39) 4. Behavioural functioning, measured using executive subscales of the Brock Adaptive Functioning Questionnaire (BAFQ) (participant and significant other ratings) 5. Caregiver burden, measured using the Zarit Burden Interview 6. Executive functions (planning skills, inhibition, abstract reasoning, problem solving and estimation of time), measured using the Behavioural Assessment of the Dysexecutive Syndrome (BADS) 7. Selective attention and attentional switching or cognitive flexibility, measured using the Test of Everyday Attention (TEA)

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026