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Behavioral Intervention

Cognitive Strategy Training for Parkinson's-Related Cognitive Impairment (PMT2 Trial)

N/A

Waitlist Available

Led By Erin Foster, PhD, OTD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hoehn & Yahr stage I-III

Treated with levodopa/carbidopa

Must not have

Other neurological disorders (e.g. stroke, seizures), brain surgery, severe systemic diseases, major psychiatric disorder or history of psychotic symptoms (e.g. schizophrenia, bipolar disorder, delusions, hallucinations), or drug abuse

Treatment with medications that interfere with cognition (e.g. anticholinergics)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up administered at baseline, pre-treatment session; one week post-treatment (approximately five weeks after the baseline test); and 12-months post-strategy training sessions.

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether process or strategy training can help improve cognitive skills in people with Parkinson's disease.

Who is the study for?

This trial is for people over 50 with typical idiopathic Parkinson's Disease (stages I-III), taking levodopa/carbidopa, and who have memory complaints but not dementia. Participants need an informant for ratings, stable medication use, and must be able to undergo MRI scans without issues.

What is being tested?

The study tests two types of memory training in a single-blind randomized controlled trial: process training versus strategy training. Participants will undergo pre-training assessments, complete eight sessions over four weeks, post-training assessments within a week after finishing the sessions, and follow-ups at 3 months, 6 months, and one year.

What are the potential side effects?

Since this trial involves cognitive strategy trainings rather than medications or invasive procedures, there are no direct physical side effects expected from the interventions being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My Parkinson's disease is in the early to mid stages.

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I am currently taking levodopa/carbidopa.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe neurological disorders, major psychiatric conditions, or a history of drug abuse.

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I am not taking any medications that affect my thinking.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ administered at baseline, pre-treatment session; one week post-treatment (approximately five weeks after the baseline test); then 3-, 6- and 12-months post-completion of strategy training sessions.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~administered at baseline, pre-treatment session; one week post-treatment (approximately five weeks after the baseline test); then 3-, 6- and 12-months post-completion of strategy training sessions.

This trial's timeline: 3 weeks for screening, Varies for treatment, and administered at baseline, pre-treatment session; one week post-treatment (approximately five weeks after the baseline test); then 3-, 6- and 12-months post-completion of strategy training sessions. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Bangor Goal Setting Interview goal attainment after 5-weeks and 12-month post-intervention.

Change in The Prospective and Retrospective Memory Questionnaire scores after 5-weeks, 3-months, 6-months, and 12-month post-intervention.

Change in Virtual Week Computer-based Memory Test performance after 5-weeks and 12-month post-intervention.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Strategy TrainingExperimental Treatment1 Intervention

Consists of 8-90 minute sessions over 8 weeks. In sessions 1 and 2, in addition to teaching about event- and time-based tasks, the therapist teaches the participant specific strategies for each type of task (implementation intentions for event-based and strategic clock-checking for time-based) and instructs in their use before and during the training games. In sessions 3-8, the tester tells the participant s/he will be practicing both types of tasks in the training games and can support the participant's strategy use if needed. Feedback on accuracy and strategy use are provided after each training game. After completing the training games, the therapist and participant discuss how the strategies can be applied to the participant's real-life prospective memory goals, and the therapist helps the participant develop written action plans to do so. Plans and goals are reviewed and modified, if necessary, at each session.

Group II: Process TrainingActive Control1 Intervention

Consists of 8, 90 minute sessions over 8 weeks. In sessions 1 and 2, the therapist teaches the participant about event- and time-based prospective memory tasks, respectively. In sessions 3-8, the tester tells the participant that s/he will be practicing both types of tasks in the training games. In all sessions, the participant completes the training games with no strategy instruction from the therapist. Feedback on accuracy is provided after each training game. This is typical of a process training approach and expects that practice of the training tasks will improve prospective memory ability per se or that participants will develop effective strategies for completing prospective memory tasks on their own. At the end of each session, the therapist reminds the participant of his/her real-life prospective memory goals, provides a handout that lists the goals, and instructs the participant to try to complete them as intended. Goals are reviewed and modified if necessary.

0 / 4Eligibility criteria met