Cognitive Strategy Training for Parkinson's-Related Cognitive Impairment

(PMT2 Trial)

Overseen By Tasha Doty, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must be taking: Levodopa/carbidopa

Must not be taking: Anticholinergics

Disqualifiers: Dementia, Stroke, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 8 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators will aim enroll participants into our study within 3-6 months after their parent study visit so the investigators can utilize some key data points (e.g. PD-MCI diagnosis, rs-fcMRI data) from that study. PD participants will participate in a single-blind RCT with two treatment arms: process training and strategy training (Fig 4). They will complete pre-training assessment (Pre), be randomized to treatment arm (1:1 ratio stratified by sex), and then complete 8 training sessions over an 8-week period. They will return within 1 week for post-training assessment (Post) and then will complete Follow-up (FU) assessments via web or mailed survey 3 and 6 months after training ends. They will complete a 12mo FU assessment in person in conjunction with their annual parent study visit. HC participants will complete prospective memory assessment at one time point coinciding with (or within 3-6 months of) their parent study visit to determine whether any relationships observed between rs-fcMRI data and prospective memory are specific to PD.

Will I have to stop taking my current medications?

You will not have to stop taking your current medications, but they should be stable for 4 weeks before starting the study and remain unchanged during the treatment period. Any changes after the treatment period will be tracked.

What data supports the effectiveness of the treatment Strategy Training, Metacognitive Strategy Training for Parkinson's-related cognitive impairment?

Research shows that strategy training can help improve everyday life functioning in people with Parkinson's disease, with some benefits seen shortly after treatment. Additionally, Parkinson's patients often use fewer memory strategies, suggesting that training in these strategies could be beneficial. ^{1 2 3 4 5}

Is cognitive strategy training safe for people with Parkinson's disease?

Cognitive strategy training, including programs like ReSET, has been shown to be safe for people with Parkinson's disease, as participants were able to complete the treatments with minimal drop-outs despite their motor symptoms and fatigue. ^{1 2 3 4 6}

How is the treatment Strategy Training different from other treatments for Parkinson's-related cognitive impairment?

Strategy Training, also known as Metacognitive Strategy Training, is unique because it focuses on teaching patients compensatory techniques to improve cognitive functions like memory and attention, rather than directly targeting the disease itself. This approach is different from other treatments as it emphasizes self-awareness and self-regulation to help patients manage their cognitive challenges more effectively. ^{7 8 9 10 11}

Research Team

Erin Foster, PhD, OTD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for people over 50 with typical idiopathic Parkinson's Disease (stages I-III), taking levodopa/carbidopa, and who have memory complaints but not dementia. Participants need an informant for ratings, stable medication use, and must be able to undergo MRI scans without issues.

Inclusion Criteria

My Parkinson's disease is in the early to mid stages.

My medications have been the same for the last 4 weeks and won't change during the study.

I am over 50 and diagnosed with typical Parkinson's disease.

Exclusion Criteria

I do not have severe neurological disorders, major psychiatric conditions, or a history of drug abuse.

I have mental health symptoms like anxiety or depression, but they don't stop me from participating.

Contraindications or inability to participate in MRI

Timeline

Screening

Participants are screened for eligibility to participate in the trial

3-6 months

Pre-training Assessment

Participants complete pre-training assessments and are randomized to treatment arms

1 week

1 visit (in-person)

Treatment

Participants undergo 8 training sessions over an 8-week period, focusing on process or strategy training

8 weeks

8 visits (in-person)

Post-training Assessment

Participants complete post-training assessments to evaluate immediate effects of the intervention

1 week

1 visit (in-person)

Follow-up

Participants are monitored for long-term effects of the intervention with assessments at 3, 6, and 12 months post-training

12 months

3 visits (web or mailed survey), 1 visit (in-person)

Treatment Details

Interventions

• Strategy Training

Trial Overview The study tests two types of memory training in a single-blind randomized controlled trial: process training versus strategy training. Participants will undergo pre-training assessments, complete eight sessions over four weeks, post-training assessments within a week after finishing the sessions, and follow-ups at 3 months, 6 months, and one year.

Participant Groups

Group I: Strategy Training Experimental Treatment 1 Intervention

Consists of 8-90 minute sessions over 8 weeks. In sessions 1 and 2, in addition to teaching about event- and time-based tasks, the therapist teaches the participant specific strategies for each type of task (implementation intentions for event-based and strategic clock-checking for time-based) and instructs in their use before and during the training games. In sessions 3-8, the tester tells the participant s/he will be practicing both types of tasks in the training games and can support the participant's strategy use if needed. Feedback on accuracy and strategy use are provided after each training game. After completing the training games, the therapist and participant discuss how the strategies can be applied to the participant's real-life prospective memory goals, and the therapist helps the participant develop written action plans to do so. Plans and goals are reviewed and modified, if necessary, at each session.

Group II: Process Training Active Control 1 Intervention

Consists of 8, 90 minute sessions over 8 weeks. In sessions 1 and 2, the therapist teaches the participant about event- and time-based prospective memory tasks, respectively. In sessions 3-8, the tester tells the participant that s/he will be practicing both types of tasks in the training games. In all sessions, the participant completes the training games with no strategy instruction from the therapist. Feedback on accuracy is provided after each training game. This is typical of a process training approach and expects that practice of the training tasks will improve prospective memory ability per se or that participants will develop effective strategies for completing prospective memory tasks on their own. At the end of each session, the therapist reminds the participant of his/her real-life prospective memory goals, provides a handout that lists the goals, and instructs the participant to try to complete them as intended. Goals are reviewed and modified if necessary.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Findings from Research

A novel client-centered cognitive strategy training intervention for people with Parkinson's disease (PD) was found to be feasible and well-accepted, with high participant satisfaction and engagement scores.

The intervention showed promising effects on self-identified cognitive problems, with significant improvements in functional ratings measured by the Canadian Occupational Performance Measure (COPM) after treatment sessions lasting an average of 9.2 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a cognitive strategy training intervention for people with Parkinson's disease. Foster, ER., Spence, D., Toglia, J.[2019]

A pilot study involving 10 adults with stroke-related cognitive impairments showed that strategy training, when added to usual rehabilitation care, is feasible and well-accepted, with high participant retention and satisfaction rates.

Participants who received strategy training demonstrated significantly less disability at six months compared to those who received an attention control session, suggesting that this approach may effectively enhance recovery in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing complex interventions: lessons learned from a pilot study examining strategy training in acute stroke rehabilitation. Skidmore, ER., Dawson, DR., Whyte, EM., et al.[2021]

An adapted metacognitive strategy training protocol for 16 adults with mild to moderate aphasia was found to be feasible in an inpatient stroke rehabilitation setting, with therapists delivering the intervention effectively.

Participants showed significant improvement in disability, achieving a mean change of 21.8 on the Functional Independence Measure, comparable to results from previous trials involving individuals without aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metacognitive Strategy Training Is Feasible for People With Aphasia. Kersey, J., Evans, WS., Mullen, K., et al.[2022]

Meta-cognitive strategy training, specifically the CO-OP method, was successfully implemented during inpatient rehabilitation for a patient with cognitive impairments after a right hemisphere stroke, showing its feasibility in a clinical setting.

The participant demonstrated significant improvements in rehabilitation engagement and functional independence, with notable increases in performance scores across various measures, suggesting potential benefits of this training approach for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of meta-cognitive strategy training in acute inpatient stroke rehabilitation: case report. Skidmore, ER., Holm, MB., Whyte, EM., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Feasibility of a cognitive strategy training intervention for people with Parkinson's disease. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of ReSET; a strategic executive treatment for executive dysfunctioning in patients with Parkinson's disease. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Improving functional disability and cognition in Parkinson disease: randomized controlled trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Memory perception and strategy use in Parkinson's disease. [2022]

5. Sweden pubmed.ncbi.nlm.nih.gov

Applied cognitive strategy behaviours in people with parkinson's disease during daily activities: A cross-sectional study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Cognitive training in Parkinson disease: A systematic review and meta-analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Strategy-Based Cognitive Training for Improving Executive Functions in Older Adults: a Systematic Review. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Developing complex interventions: lessons learned from a pilot study examining strategy training in acute stroke rehabilitation. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Metacognitive Strategy Training Is Feasible for People With Aphasia. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The feasibility of meta-cognitive strategy training in acute inpatient stroke rehabilitation: case report. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Does metacognitive strategy instruction improve impaired receptive cognitive-communication skills following acquired brain injury? [2015]