Recruiting

Strategy Training

Sponsor:

Washington University School of Medicine

Code:

NCT07190404

Conditions

PARKINSON DISEASE (Disorder)

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

A metacognitive strategy for cognitive rehabilitation called the Multicontext Approach.

Cognitive (Process) Training

MC Approach Booster Session

Study Details

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)

Study ID

NCT07190404

Start date

May 20, 2026

Status verified date

Jul, 2026

Completion date

Aug 31, 2030

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

114 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MC Approach

The experimental Multicontext Approach Intervention

active comparator: Process Training

The Control Group cognitive process training

experimental: 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.

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.

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.

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.

Primary outcome measure

  • Bangor Goal Setting Interview [ Time Frame: 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). ]

Central Contacts and Locations

Central contacts

Tasha D Doty, MA

785-865-8943tdoty@wustl.edu

Erin Foster, PhD

314-286-1638erfoster@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Michelle Jenkerson, RN, BS, RRT, CCRC

314-362-5626Jenkerson_m@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • Parkinson Disease
  • occupational therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-14.