Multicontext Approach for Cognitive Function in Parkinson Disease

NCT07190404 | Not Yet Recruiting DMC

• 1 other identifier: 202508056
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PARKINSON DISEASE (Disorder)

Keywords

Parkinson Disease; occupational therapy

Outcome Measures

Primary Outcomes (1)

• Bangor Goal Setting Interview

  A standardized cognitive rehabilitation tool to identify functional cognitive problems and develop treatment goals. Participants rate their goal attainment on a scale from 0 (not successful) to 10 (very successful); readiness to work on the specific goal on a scale of 0 (not ready to change) to 10 (Extremely ready to change); and the importance of the goal to them on a scale from 0 (not important) to 10 (extremely important).

  Goals will be assessed during the intervention at 2- and 4-weeks after Baseline testing; at POST intervention 11-weeks after Baseline; then one year from the final intervention session (63-weeks after Baseline).

Secondary Outcomes (3)

• The Cognitive Self-Efficacy Questionnaire

  Participants will complete this questionnaire at the Baseline session, then after the participant finishes the intervention sessions at 11-, 23-, 35- and 63-weeks after Baseline.

• The Weekly Calendar Planning Activity

  The weekly calendar planning activity is administered at treatment session 1 of the intervention (1 week after Baseline), then after the participant completes the intervention at 11- and 63-weeks after Baseline.

• The Self-Regulation Skills Interview

  Participants are interviewed with the SRSI at treatment session 1 of the intervention (1 week after Baseline) then 1-week post intervention (11 weeks after Baseline).

Study Arms (3)

MC Approach

EXPERIMENTAL

The experimental Multicontext Approach Intervention

Behavioral: A metacognitive strategy for cognitive rehabilitation called the Multicontext Approach.

Process Training

ACTIVE COMPARATOR

The Control Group cognitive process training

Behavioral: Cognitive (Process) Training

MC + Booster

EXPERIMENTAL

From the MC Approach group only, MC+Boster participants will receive 2 additional treatment sessions with their original OT within the month following their 6mo FU assessment.

Behavioral: MC Approach Booster Session

Interventions

Cognitive (Process) Training BEHAVIORAL

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.

Process Training

MC Approach Booster Session BEHAVIORAL

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.

MC + Booster

A metacognitive strategy for cognitive rehabilitation called the Multicontext Approach. BEHAVIORAL

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.

MC Approach

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Microscopy, Electron, Scanning Transmission

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Microscopy, Electron, Transmission; Microscopy, Electron; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Erin R Foster, PhD, OTDR/L

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tasha D Doty, MA

CONTACT

785-865-8943; tdoty@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 24, 2025
• Study Start: April 22, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2030
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Shared data generated from this project will be made available as soon as possible, and no later than the time of publication or within 9 months of database lock, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 5 years after the end of the funding period.
• Access Criteria: Human subjects' data will be shared within IRB bounds. WashU HRPO (Human Research Protection Office) typically recommends sharing de-identified data in a controlled manner. We will share de-identified data in Digital Commons@Becker, requiring requestors to sign a Data Use Agreement (DUA) unless directed otherwise by WashU HRPO/IRB.

Locations

US (1)