NCT02826785

Brief Summary

This study investigates the feasibility of a cognitive strategy training intervention for people with Parkinson disease (PD). We plan to recruit 8 non-demented PD participants to complete 6 weekly treatment sessions and Pre- and Post-testing (8 sessions total, entire study duration per participant = 8 weeks). We will measure participant responsiveness and the overall efficiency of the intervention process.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started May 2014

Typical duration for not_applicable parkinson-disease

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2016

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
Last Updated

May 24, 2018

Status Verified

May 1, 2018

Enrollment Period

2 years

First QC Date

June 29, 2016

Last Update Submit

May 23, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Client Satisfaction Questionnaire

    8 weeks

Study Arms (1)

Cognitive strategy training

EXPERIMENTAL

The cognitive strategy training intervention consists of 6 weekly \~1 hour sessions. It is delivered in an individual, face-to-face format in the client's home. It is a behavioral intervention that teaches people metacognitive, problem-solving and other compensatory strategies to address self-identified cognitive performance problems, and it uses practice and homework to promote strategy learning, retention and transfer.

Behavioral: Cognitive strategy training

Interventions

The intervention teaches strategies in a way that promotes generalization and enhances daily function . It includes four core elements known to enhance learning transfer: (1) self-generation of broadly applicable strategies, (2) practice across multiple contexts and activities, (3) emphasis on metacognition, and (4) use of meaningful everyday activities.

Cognitive strategy training

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females over age 50 who meet criteria for idiopathic typical PD, are Hoehn \& Yahr stage I-III (mild to moderate disease; Hoehn \& Yahr, 1967) and are treated with levodopa/carbidopa. For this early phase of development we will limit enrollment to people who can identify at least one daily cognitive performance problem and are willing to learn strategies to address it.

You may not qualify if:

  • Possible dementia, medication change over the study period, other neurological disorders, brain surgery (e.g., STN DBS), history of psychotic disorder or significant current psychiatric disorder (i.e., moderate to severe anxiety, apathy or depression), or any condition that would interfere with participation (e.g., non-English speaking). Participants taking benzos will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Erin R Foster, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 11, 2016

Study Start

May 1, 2014

Primary Completion

May 1, 2016

Study Completion

July 1, 2016

Last Updated

May 24, 2018

Record last verified: 2018-05