Prospective Memory Training in Parkinson Disease
Prospective Memory Training in Parkinson Disease
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:

 1. Process Training Group - the trainer teaches the participant about event- and time-based
 prospective memory tasks, respectively. The trainer simply tells the participant that
 s/he will be practicing both types of tasks in training games.

 2. Strategy Training Group - 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.

 3. Contro1 Group - Receives no training sessions. Only Completes the PRE, POST and 1-month
 & 3-month Follow Up portions of the study.

 STUDY VISITS

 -  On the day of their testing appointment, participants will arrive at their designated
 location at the WUSM Movement Disorders Clinic for their testing session. All
 participants will provide written informed consent before their first testing session
 begins, and the examiner will answer any questions before beginning testing. Scheduled
 participants will be mailed or emailed (depending on their preference) study information
 and a copy of the consent form. Participants will receive reminder calls 1-2 days before
 their appointments.

 -  Demographics will be collected on all participants. This includes age, gender, years of
 education, living status, race, and ethnicity after consent is obtained. This can be
 completed online via Redcap or on paper at the testing session.

 -  Investigators will collect PD clinical characteristics from the Movement Disorders
 Clinical Record. Clinical Characteristics includes: Hoehhn & Yahr Stage, year of first
 PD symptoms, year of initial PD diagnosis, MoCA score at most recent clinic visit, Side
 of symptom onset, type of symptom onset (tremor vs. bradykinesia), PD medications, and
 most recent Unified Parkinson Disease Rating Scale Motor Score.

 Participant Questionnaires:

 Participants will complete the PRMQ, CAPM, IPA and BDI questionnaires.

 -  Prospective and Retrospective Memory Questionnaire (PRMQ; attached) - Used to rate the
 participant's everyday retrospective and prospective memory.

 -  Comprehensive Assessment of Prospective Memory (CAPM; attached) - Used to rate the
 participant's everyday prospective memory

 -  Impact of Participation and Autonomy (IPA; attached)- A questionnaire about the
 participant's ability to take part in daily activities.

 -  Beck Depression Inventory (BDI, attached) - Used to characterize current depression,
 which is common in PD.

 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.

 -  The Montreal Cognitive Assessment (MoCA; attached) will be administered to assess global
 cognition at the time of the study visit.

 -  The Virtual Week test (attached) will be administered to the participant. It is 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).

 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.

 -  The Bangor Goal-Setting Interview (BGSI) - The BGSI is a structured assessment developed
 for use in cognitive rehabilitation research. It offers a standardized means of
 eliciting individual goals and rating goal attainment over time and has been
 successfully used in RCTs with older adults, including those with mild to moderate
 dementia. During the first two training sessions, after an explanation of the
 prospective memory task types (session 1: event, session 2: time), participants complete
 the BGSI with the trainer to identify and set goals for their real-life prospective
 memory tasks. Participants identify up to 6 prospective memory tasks they anticipate
 having to complete over the next 2 weeks (before Post assessment), define goals for
 completing each task, and describe what needs to happen for the goal to be considered
 partially (25%, 50%, and/or 75%) and fully achieved.

 -  Credibility/ Expectancy Questionnaire (CEQ; attached) - this will be completed by the
 participant after the second training session to rate how credible they think the
 strategy instruction training is, and how well they think it will work on 1) their
 performance on the computer task, and 2) their performance in everyday life.

 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

 -  The Virtual Week Task will be administered again, but with new tasks to remember.

 -  The NIH Toolbox Cognitive Battery (instructions attached) will be administered to obtain
 an overall measure of executive function. This battery includes a Picture Vocabulary
 Test, Picture Sequence Memory Test, Flanker Inhibitory Control and Attention Test,
 Dimensional Change Card Sort Test, List Sorting Working Memory Test, Pattern Comparison,
 and Oral Reading Test.

 -  GROUPS 1 (Process) and 2 (STRATEGY) ONLY: Based on their BGSI interview during the
 training sessions, participants report on their performance of each task and, in
 collaboration with the trainer, rate each task for attainment on a 10-point scale using
 the previously determined descriptors as reference (higher scores indicate better goal
 attainment). Task attainment scores are averaged to yield a mean attainment score.

 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).
Inclusion Criteria:

 -  Males and females over age 50

 -  Meet criteria for typical idiopathic PD

 -  Hoehn & Yahr stage I-III

 -  Treated with levodopa/carbidopa

 -  Have PD with Mild Cognitive Impairment (PD-MCI) according to Movement Disorders
 Society (MDS) Level II diagnostic criteria.

 -  Medications should be stable for 4 weeks prior with no changes planned during the
 study (we will document any unplanned changes).

 Exclusion Criteria:

 -  Dementia according to MDS criteria or MoCA score <21

 -  Other neurological disorders,

 -  Brain surgery

 -  History of psychotic disorder

 -  Change in medication during the study

 -  Treatment with medications that interfere with cognition (e.g. anticholinergics)

 -  Any condition that would interfere with participation (e.g., non-English speaking,
 significant current depression).