Feasibility and Optimization of a Cognitive Intervention for Parkinson Disease

NCT ID: NCT02826785

Last Updated: 2018-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-07-31

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.

Detailed Description

Cognitive impairment is common in Parkinson disease (PD) and is a significant source of disability and reduced quality of life. Existing rehabilitative interventions, which focus on cognitive process training, have not been successful in mitigating its negative functional consequences. We have developed a client-centered cognitive strategy training intervention to enable people with PD to work around their cognitive deficits and maintain their functional performance. This study is an exploratory case series to assess aspects of its feasibility. Specifically, we will assess participant responsiveness to the intervention (acceptance, engagement, adherence), and we will track logistical information (e.g., scheduling). We will also administer an exploratory outcome measure of treatment effect to gain preliminary evidence on the effect of the intervention on self-identified cognitive performance problems. This information will guide modifications and enhancements in preparation for future clinical trials.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive strategy training

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.

Group Type: EXPERIMENTAL

Cognitive strategy training

Intervention Type: BEHAVIORAL

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.

Interventions

Cognitive strategy training

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Erin Foster

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erin R Foster, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Other Identifiers

201403072

Identifier Type: -

Identifier Source: org_study_id