Multicontext Approach for Cognitive Function in Parkinson Disease

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07190404
Status
Recruiting
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Conditions

  • PARKINSON DISEASE (Disorder)

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
May 20, 2026
Status verified
May 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2030

Study Design

Enrollment
114 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Michelle Jenkerson, RN, BS, RRT, CCRC
[email protected]
314-362-5626

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Washington University School of Medicine· St Louis, MO

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