RecruitingNot ApplicableNCT07190404

Multicontext Approach for Cognitive Function in Parkinson Disease

Efficacy and Mechanisms of a Metacognitive Strategy Intervention for Parkinson Disease-Related Cognitive Decline.


Sponsor

Washington University School of Medicine

Enrollment

114 participants

Start Date

May 20, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Mild cognitive decline is common in early Parkinson disease (PD) and is associated with disability, reduced quality of life (QOL), and increased risk for dementia. Medical treatments for PD do not prevent or treat cognitive decline and may even exacerbate the problem. Unfortunately, existing cognitive interventions for PD, which focus on restoring deficient cognitive skills through cognitive training (repetitive practice of tasks that challenge specific cognitive skills), provide limited benefit for daily function and QOL. To overcome this limitation, the investigators use strategy training. the investigators help people develop targeted strategies to use in everyday life to circumvent cognitive deficits and accomplish daily activities. Contemporary cognitive rehabilitation evidence supports strategy training for other neurological conditions and mild cognitive impairment (MCI), but it has not been well-studied in PD. By teaching strategies for everyday cognition, the investigators hypothesize that our interventions will improve functional outcomes for people with PD. Study participants will complete a baseline cognitive testing session, 10 cognitive treatment sessions with a trained occupational therapist, then have follow-up visits with the study team at 1-week, 3-months, 6-months, and 12-months after completing the study intervention.


Eligibility

Min Age: 50 Years

Inclusion Criteria6

  • Males and females over age 50 who meet criteria for typical idiopathic PD.
  • Hoehn \& Yahr stage I-III.
  • Have subjective cognitive decline (SCD) as defined by a positive answer to either question:
  • Do you feel like your thinking skills or memory are becoming worse or are worse than others your age?
  • Do you have problems or concerns with your thinking skills or memory?, and can list ≥1 daily cognitive challenge they want to address.
  • Medications should be stable for 4 weeks prior with no changes planned during the treatment portion of the study (Pre to Post); unplanned changes and changes over the follow-up period will be tracked and accounted for as appropriate.

Exclusion Criteria4

  • Dementia according to MDS criteria or MoCA score <21.
  • Other neurological disorders (e.g., stroke, seizures).
  • Current or history of major psychiatric disorder or psychotic symptoms (e.g., schizophrenia, bipolar disorder, delusions, hallucinations), drug abuse. Psychiatric conditions/symptoms that are common in PD (e.g., anxiety, depression) are permitted if deemed insufficient to interfere with participation.
  • Other circumstance that would interfere with participation (e.g., non-English speaking, blindness, lives >50mi away).

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Interventions

BEHAVIORALA metacognitive strategy for cognitive rehabilitation called the Multicontext Approach.

The Multicontext Approach is a strategy training approach to cognitive intervention provides ways to maintain daily function despite the presence of cognitive deficits. It involves teaching people to use metacognitive, compensatory, or adaptive techniques to optimize information processing or bypass cognitive limitations and achieve task-related goals. Strategy training is recommended for those with mild (vs. more severe) cognitive deficits because it requires learning, capitalizes on existing cognitive resources, and aims to prevent or delay functional decline.

BEHAVIORALCognitive (Process) Training

This treatment is functional task training, a widely-used approach in neurorehabilitation153,154 that parallels the cognitive training used in PD to-date but with functional cognitive tasks (vs. computer or paper \& pencil tasks) to improve ecological validity. It has the same structure within and across treatment sessions and uses the same treatment activities as the MC intervention. However, the OT does not use mediated learning techniques or explicitly address strategies, metacognition, or transfer/generalization. Rather, participants practice functional cognitive tasks with knowledge of results feedback and cueing by the OT to improve task performance.

BEHAVIORALMC Approach Booster Session

MC+B participants will come from the MC Approach group only. They will receive 2 additional treatment sessions with their original OT within the month following their 6mo FU assessment. The OT will review the participant's relevant Post and FU data beforehand for treatment planning purposes. The first session will involve a review of goals, prior learning, and strategies and discussion of successes/challenges related to functional cognitive performance and strategy application since initial treatment. Then the same protocol (treatment activities with metacognitive framework and mediation, strategy bridging discussions, homework action planning and review) will be followed for the rest of the booster treatment to reinforce or re-activate prior learning, address new concerns, and develop supports for maintenance.


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT07190404


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