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The long term goal of this work is to reduce disability among people with Parkinson disease (PD) by enabling them to cope with cognitive decline so they can perform and participate in desired activities and roles. This project focuses on prospective memory, or the ability to remember to execute delayed intentions at the appropriate moment in the future. The current study tests the effects of two primary cognitive intervention approaches (process training & strategy training) on prospective memory performance in PD. The investigators will conduct a single-blind randomized controlled trial in which individuals with mild cognitive impairment in PD (PD-MCI; N = 90) will complete pre-training assessment, randomization to training group (control, process training, strategy training), four training sessions (process and strategy training groups), and post-training assessment.
RANDOMIZATION
Once a participant is enrolled in the study and completes the Pre-testing session (described in detail below), they will be randomized into one of the following study groups:
STUDY VISITS
Participant Questionnaires:
Participants will complete the PRMQ, CAPM, IPA and BDI questionnaires.
Informant Report Questionnaires:
Participant's will identify an informant (spouse, relative, or close friend) to fill out the PRMQ Proxy Report, a Self-Reported CAPM, and a CAPM - Proxy Report.
Demographics will be collected on all informants. This includes age, gender, years of education, living status, race, and ethnicity.
Participant and Informant questionnaires can be filled out prior to the study session via Redcap. Most participants request this method because it saves them time on the day of the study session. The online questionnaires have a consent form to look over before filling them out (see attached online consent), and the participant agrees to the consent by clicking "Next" in the online form, and completing the questionnaires; if participants elect to complete the questionnaires on paper, they can complete them at their testing session. The research team will will first go over the written consent with them at the session before the participant fills out the written questionnaires. Experimenters will check the questionnaires for completion. This procedure will also be followed if the participant elects to fill out the online questionnaire in Redcap.
Testing sessions:
Participants will perform testing while on their regular PD medications.
Pre-training Assessment: (1.5 hours) - MoCA and Virtual Week.
Strategy Training Sessions (GROUPS 1-Process Training AND 2-Strategy Training ONLY): These are 4 sessions that occur over the next 2 weeks after the Pre-training Assessment. (1 HOUR EACH) GROUP 1, Process training: In sessions 1 and 2, the trainer teaches the participant about event- and time-based prospective memory tasks, respectively. In sessions 3 and 4, the trainer simply 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 trainer. Feedback on accuracy is provided after each training game. This is typical of a process training approach and expects that either practice of the training tasks will improve prospective memory ability per se or participants will develop effective strategies for completing prospective memory tasks on their own. At the end of each session after completing both training games, the trainer 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. It should be noted that the inclusion of even this minimal level of discussion of real-life cognitive tasks is not typical of process training interventions.
GROUP 2, Strategy Training: In training sessions 1 and 2, in addition to teaching about event- and time-based tasks, the trainer 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 and 4, the trainer 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. At the end of each session after completing the training games, the trainer and participant discuss how the strategies can be applied to the participant's real-life prospective memory goals, and the trainer helps the participant develop written action plans to do so. Plans are reviewed (and modified if necessary) at each session.
Post-training Assessment (1.5 hours) - (For Groups 1 (Process) and 2 (Strategy) = One week after the last training session; For Group 3 (Control) = 3-4 weeks after the Pre-Training Assessment): Virtual Week and NIH Toolbox Cognitive Battery
One-month Follow-up Assessment (40 minutes) (One month after the Post Training Assessment):
The PRMQ, IPA and CAPM Questionnaires will be given to participants for a second time as follow-up online in Redcap or by mail (depending on the participant's preference).
The study informant will fill out proxy-reported PRMQ and CAPM for a second time as a follow-up online in Redcap or by mail (depending on the informant's preference).
Three-month Follow-up Assessment (40 minutes) (Three months after the Post Assessment):
The PRMQ, CAPM, and IPA Questionnaire will be given to participants for a third time as follow-up online in Redcap or by mail (depending on the participant's preference).
The study informant will fill out proxy-reported PRMQ and CAPM for a third time as a follow-up online in Redcap or by mail (depending on the informant's preference).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strategy Training Intervention | Experimental | Study participants receive specific memory strategy training with training games, as well as feedback on accuracy and performance. |
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| Process Training | Active Comparator | Study participants attend training sessions and complete training games, but receive no specific strategy training |
|
| Control Group | Other | Study participants do not attend any strategy training sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strategy Training | Behavioral | Participants will attend four strategy training sessions total. In sessions 1 and 2, in addition to teaching about event- and time-based tasks, the trainer teaches the participant specific strategies for each type of task (implementation intentions for event-based and strategic clock-checking for time-based). In sessions 3 and 4, the trainer 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. At the end of each session after completing the training games, the trainer and participant discuss how the strategies can be applied to the participant's real-life prospective memory goals, and the trainer helps the participant develop written action plans to do so. Plans are reviewed (and modified if necessary) at each session. |
| Measure | Description | Time Frame |
|---|---|---|
| Virtual Week | A computerized board game that simulates daily life and real-world prospective memory challenges. Each circuit represents one day in which the participant completes time-appropriate activities and makes choices about them (i.e. the ongoing activity). Each day has 8 prospective memory tasks (4 event based, 4 time based). Participants complete a practice day and then three test days, with equivalent versions counterbalanced across Pre and Post testing. The main outcome variable is the proportion of correct prospective memory responses for each task type (12 event based, 12 time based). Change of performance on the Virtual Week from the Pre- and Post-session will be measured. | 4 to 6 weeks |
| Prospective and Retrospective Memory Questionnaire | Used to rate the participant's everyday retrospective and prospective memory. Change in scores on this questionnaire will be measured. | Through completion of the study, up to 16 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
| Process Training | Behavioral | Participants will attend four process training sessions in this group. In sessions 1 and 2, the trainer teaches the participant about event- and time-based prospective memory tasks, respectively. In sessions 3 and 4, the trainer simply 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 trainer. Feedback on accuracy is provided after each training game. At the end of each session after completing both training games, the trainer 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. Of note, even this minimal level of discussion of real-life cognitive tasks is not typical of process training interventions, but we include it to control for that which is occurring in the strategy training group. |
|
| Control Group | Behavioral | Participants in this group do not attend any sessions during the time the other groups are participating in the Strategy or Process Training |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D008722 | Methods |