Multicontext Approach for Cognitive Function in Parkinson Disease

NCT ID: NCT07190404

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-02
• Study Completion Date: 2030-08-31

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.

Detailed Description

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. Therefore, behavioral interventions that attenuate its negative functional consequences and thus potentially delay dementia onset are a top research priority. 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.

Specifically, the investigators use the Multicontext (MC) Approach to support daily cognitive function in people with PD with mild cognitive decline. The MC Approach is a metacognitive strategy intervention that targets awareness, strategy use, and self-efficacy to improve functional cognitive performance in daily life. Through therapist- mediated experiences with cognitively challenging functional activities, participants develop personalized strategies (e.g., self-talk, planning, checklists) to prevent or correct cognitive performance errors. The goal is to enable people to manage everyday cognitive challenges so they can perform and participate in meaningful activities and roles. In a development and proof-of-concept study, the investigators adapted and refined the treatment protocol and training materials, established good participant acceptance, and provided preliminary data on its benefits for daily cognitive function. In a subsequent pilot quasi-randomized controlled trial (R21AG063974), the investigators established trial feasibility and treatment fidelity and generated promising treatment effect data. Notably, the MC Approach produced clinically meaningful improvements in daily cognitive function that were larger than that of the cognitive task training control and that were maintained 3 and possibly 12 months post treatment. the investigators now have the experience, methods, and data to justify and prepare us for a full-scale efficacy trial.

The investigators will conduct a randomized controlled trial (RCT) to determine the short- and long-term efficacy of the MC Approach for improving daily cognitive function in people with PD with mild cognitive decline. Secondarily, the investigators will examine whether booster treatment enhances treatment effects and explore the cognitive-behavioral mechanisms of the MC Approach. PD participants (N=114) will complete baseline assessment, randomization to treatment group (MC n=76, Control n=38), 10 treatment sessions (1x/week), and 1 week, 3 months, and 6 months post treatment assessment. MC participants will then be randomized to a booster (MC+B n=38) or no-booster (MC n=38) condition, and the MC+B group will receive booster treatment within the following month. Then all three groups (Control, MC, MC+B) will complete 12-month assessment. Mixed model repeated measures analysis of variance will be used to compare change across treatment groups and over time.

Our primary study aims and hypotheses are:

Aim 1: Determine the effect of the MC Approach on daily cognitive function. H1: The MC group will report greater improvements in daily cognitive function than the Control group 1 week (H1a; short-term) and 12 months (H1b; long-term) post treatment. Participants will rate their performance on personalized functional cognitive goals using a standardized cognitive rehabilitation tool (primary outcome: Bangor Goal Setting Interview, (BGSI) at each testing timepoint. Primary analyses will include the 1-week and 12-month data for Control and MC participants; additional analyses can look at trajectories across all timepoints.

Aim 2: Examine the effect of booster MC Approach treatment on daily cognitive function.

H2: The MC+B group will report better daily cognitive function 12 months post initial treatment than the MC group. At 6 months post, MC+B participants will receive two booster treatment sessions to review and reinforce their learning and strategy use. Primary analyses will include the 6- and 12-month BGSI data, controlling for baseline.

Aim 3: Explore the effect of the MC Approach on the theorized intermediate treatment targets.

H3: The MC group will have greater improvements in awareness, strategy use, and self-efficacy than the Control group after treatment. Participants will complete measures of awareness, strategy use, and self-efficacy at each testing timepoint. Primary analyses will include all available timepoints. To further explore mechanisms of action, correlational analyses will examine if change in the targets relates to change in functional outcomes.

Conditions

PARKINSON DISEASE (Disorder)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MC Approach

The experimental Multicontext Approach Intervention

Group Type: EXPERIMENTAL

A metacognitive strategy for cognitive rehabilitation called the Multicontext Approach.

Intervention Type: 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.

Process Training

The Control Group cognitive process training

Group Type: ACTIVE_COMPARATOR

Cognitive (Process) Training

Intervention Type: 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.

MC + Booster

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.

Group Type: EXPERIMENTAL

MC Approach Booster Session

Intervention Type: 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.

Interventions

A 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.

Intervention Type: BEHAVIORAL

Cognitive (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.

Intervention Type: BEHAVIORAL

MC 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Males and females over age 50 who meet criteria for typical idiopathic PD.

2. Hoehn & Yahr stage I-III.

3. 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.

4. 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 Criteria

1. Dementia according to MDS criteria or MoCA score <21.

2. Other neurological disorders (e.g., stroke, seizures).

3. 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.

4. Other circumstance that would interfere with participation (e.g., non-English speaking, blindness, lives >50mi away).

• 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

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erin R Foster, PhD, OTDR/L

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Central Contacts

Tasha D Doty, MA

Role: CONTACT

tdoty@wustl.edu

785-865-8943

Facility Contacts

Michelle Jenkerson, RN, BS, RRT, CCRC

Role: primary

Jenkerson_m@wustl.edu

314-362-5626

Other Identifiers

202508056

Identifier Type: -

Identifier Source: org_study_id