Moving Mindfully: A MBSR-Centered Approach to Freezing in Parkinson Disease
Phase: NA
Conditions: Parkinson Disease, Freezing of Gait
Sponsor: Washington University School of Medicine

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Moving Mindfully for Freezing in Parkinsons 
NCT 05309083 
Date 09/19/2022 
 

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Moving Mindfully: AIM 1/AIM 2 Protocol/SAP  
RESEARCH DESIGN AND METHODS 
 
Aim 1: Create a Mindfulness-Based Walking Therapy (MBWT) program by modifying the MBSR standard 
protocol based upon feedback from an advisory group. An advisory group consisting of physical therapists, 
mindfulness instructors, research team members, 3-5 people with PD+FOG and their care partners will provide 
input regarding adaptations needed to make the standard MBSR program acceptable and feasible for people 
with PD+FOG and to shift the focus from sitting, standing, or lying meditations to walking mediations. 
 
RATIONALE 
The use of an advisory group is a collaborative and valuable research tool that will provide integrated insight to 
modify the standardized MBSR protocol. 
 
DESIGN 
We will recruit 3-5 people with PD+FOG and their care partners and schedule a series of collaborative meetings 
with team members including the research physical therapist and mindfulness instructors to: 1) modify the MBSR 
program by replacing sitting, lying, and standing meditations with walking mediations and ensuring the content 
is appropriate and clear for people who have PD+FOG; and 2) finalize a protocol that will include the MBSR 
Standards of Practice (SOP). To facilitate these goals, the advisory group will convene once a week for eight 
weeks that will include discussions about FOG knowledge, existing mindfulness training in PD and older adult 
literature, inclusion/exclusion criteria, outcome and feasibility measures, and technology usage for tracking 
adherence. An outline for these objectives is included in the Narrative Study Description.   
People with PD+FOG will also be asked to participate in phone interviews to ask questions about their history 
with FOG and anxiety using questions on the FOG and Anxiety Questionnaire. Information from this interview 
will provide information about how participants describe and experience FOG and anxiety in their own words and 
what different scenarios or environments tend to elicit FOG.  
 
A Mindfulness-Based Stress Reduction Workbook. We will use the MBSR Workbook to facilitate the 
program. The MBSR Workbook follows the teachings and SOP written by Jon Kabat-Zinn and includes both 
formal and informal practices to better understand and learn mindfulness. There are places to journal, self-reflect, 
and schedule time to practice mindfulness. Members of the advisory group will receive a copy of the workbook 
to review for two main purposes: 1) exchange meditations that include sitting, lying, or standing mindfulness 
practices with walking meditations; and 2) ensure the meditations are appropriate and clear for our population. 
We will follow the recommendations on how to use the MBSR workbook and include the majority of the current 
mindfulness practices that are included to ensure adequate mindfulness training. The MBSR Workbook currently 
includes one walking meditation and the advisory group will create additional walking meditations that address 
situations that are difficult for people living with PD+FOG. For instance, turning is a frequent occurrence in our 
daily lives. Additional walking meditations to be proposed will include using mindfulness for complex walking 
scenarios such as places with large crowds, places that require quick movements such as getting on or off an 
elevator, walking through narrow spaces and doorways, and surfaces that change (i.e., tile to carpet). Walking 
mediations that require stopping and starting frequently could address freezing that occurs at gait initiation.   
MBSR Standards of Practice (SOP). The MBSR SOP was written by Jon Kabat-Zinn at the Center for 
Mindfulness in Medicine, Health Care & Society and the University of Massachusetts’s Medical School. The SOP 
includes three main sections that outline the minimum standards required to be considered a MBSR program:  
Background and Overview: Presents the fundamental values of MBSR and reflects the methodical, yet flexible, 
approach of mindfulness training. These values include embracing mindfulness as a positive and educational 
lifestyle change, incorporating it into daily practice, and the importance of living in the present moment.   

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Structure and Methods: Presents the outline of successful MBSR programs which includes a pre-program 
orientation session, eight weekly classes 2.5 hours in duration, an all-day silent retreat during the sixth week of 
the program (7.5 hours), specified mindfulness mediations methods (i.e., body scan, gentle hatha yoga, sitting 
mediation, and walking mediation) and practices (e.g., deliberate awareness during routine activities and events 
such as eating or walking), daily home assignments (e.g., journaling, reading), individual and group dialogue, 
and exit assessments including a participant self-evaluation. The total in-class contact is 30 hours and total home 
assignments is a minimum of 42 hours.   
Program Standards: The MBSR SOP includes the following pre-program initiatives to ensure participants are 
familiar with their upcoming involvement. The Program Standards also reviews screening criteria, learning 
contract, and curriculum guidelines.  
 
Participants are given a Session Evaluation form after each session and the Client Satisfaction Questionnaire 
(CSQ)83 to complete at the end of the program, both of which provide Likert-scale questions to be used in the 
feasibility benchmarks and open-ended questions to provide qualitative data to evaluate and refine the 
meditations, instructions, and study procedures.82,84 Insights from these questionnaires and the exit interview will 
also be used to explore response distributions such as skewness, floor/ceiling effects, or missing data. 
The advisory group will be employed to address each of these sections in the MBSR SOP and determine which 
areas may need modification. Based on our knowledge of working with people with PD+FOG and preliminary 
studies of MBSR with older adults or people with Parkinson disease, we anticipate changing the all-day silent 
retreat (7.5 hours) to a half-day retreat (3.5 hours).  
Review outcome measures for clarity and burden. We will present the following outcome measures to the 
advisory group for review.  
Functional Measures. The New Freezing of Gait Questionnaire (NFOG-Q) assesses types of freezing and 
severity for the past month.86 The StepWatch Activity Monitor (SAM)87 will be worn on the ankle by participants 
24 hours per day for seven consecutive days after each evaluation to record number of daily steps. Motor 
systems will be assessed using the Movement Disorders Society Unified Parkinson’s Disease Rating Scale-III 
(MDS-UPDRS-III), an 18-item questionnaire that provides an index of motor severity.88 Balance will be assessed 
with the Mini-Balance Evaluations Systems Test (Mini-BEST).89 Participants are asked to stand on one leg, stand 
on the ground and foam surfaces, and walk while performing different tasks. During the in-person assessments, 
participants will also wear APDM’s Mobility Lab sensors90 and perform several tests including the Timed Up and 
Go and the two-minute walk test. These inertial sensors provide detailed spatiotemporal data regarding gait.  
Mindfulness Measures. The Revised Cognitive Affective Mindfulness Scale (CAMS-R) has 12 items to assess 
how participants relate to their thoughts and feelings in relation to attention, awareness, present-focus, and 
acceptance/nonjudgment in order to achieve an overall mindful state.91  
Psychological Measures. The Hamilton Anxiety Scale (HAM-A) is a 14-item questionnaire to analyze the 
symptoms and severity of psychic and somatic anxiety.92 The Hamilton Depression Scale (HAM-D) is a 21-item 
questionnaire to analyze symptoms such as depressed mood, feelings of guilt, suicidal tendencies, and 
insomnia.93 The Penn State Worry Questionnaire is a self-reporting measure with 16 items to index the amount 
of worry a person experiences.94 The Parkinson Disease Questionnaire-39 (PDQ-39) is a 39-item self-report 
survey that provides information on the impact Parkinson disease has on the participant’s quality of life.95 Overall 
Phone Call
•Focus, 
structure, and 
commitment 
reviewed
Mailing 
•Packet with 
background 
information 
about MBSR
Group Orientation 
Session
•Pre-program 
questionnaires, 
introductory 
mindfulness 
meditation 
exercise
Brief Individual 
Meetings 
•Instructors 
review pre-
program 
questionnaires
•Participant and 
instructor will 
discuss 
enrollment 
Enrollment 
•Participants 
who enroll set 
goals, discuss 
challenges, and 
schedule 
appointments 
for evaluations

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physical, mental, and social health will be measured using the Neuro-QOL Battery, a self-reported assessment 
to analyze several domains including anxiety, stigma, depression, social interactions and the ability to do physical 
tasks while living with a neurological condition.96 The Hamilton Anxiety Scale (HAM-A) is a 14-item questionnaire 
to analyze the symptoms and severity of psychic and somatic anxiety. The Hamilton Depression Scale (HAM-D) 
is a 21-item questionnaire to analyze symptoms such as depressed mood, feelings of guilt, suicidal tendencies, 
and insomnia. 
Sense of Agency Measure. The Sense of Agency scale is a tool used to measure one’s core agency by 
analyzing the extent to which someone believe to have control over their own body, thoughts, and the 
environment in order to become more aware of internal and external experiences.67 
Cognitive Measures. To measure cognition, the NIH Toolbox will be used. Tests include 1) episodic memory 
with the Picture Sequence Memory Test; 2) working memory via the List Sorting Working Memory Test; 3) the 
Picture Vocabulary Test and Oral Reading Recognition Test to test language processing; 4) executive 
functioning via the Dimensional Change Card Sort Test; 5) processing speed using the Pattern Comparison 
Processing Speed Test and Oral Symbol Digit Test; and 6) the Auditory Verbal Learning Test (Rey) to assess 
immediate recall.  
 
 
KEY FEASIBILITY ELEMENTS, EXPECTED OUTCOMES, AND BENCHMARKS 
For this first aim, our expected outcomes include demonstrating successful start-up procedures including 
regulatory approvals, formation of the advisory group, modifications of the MBSR protocol, and standardization 
of the protocol to use in Aim 2.   
 
For feasibility, we will monitor and track: 1) difficulties that arise during the start-up phase; 2) challenges with 
formation and meetings with the advisory group; 3) discussions and outcomes during each of the advisory group 
meetings to ensure objectives are met; 4) challenges that present as a result of modifying the MBSR protocol to 
focus on walking mediations; 5) comments from the advisory group regarding the outcome measures; and 6) 
comments regarding clarity of content in the MBSR workbook. 
 
Benchmarks for Aim 1 include: 1) identification and recruitment of the full advisory committee with an initial 
meeting held within the first three months of the award; 2) complete initial review of all required elements (SOP, 
Workbook, Literature, Inclusion/Exclusion Criteria, Technology) within five months of initial meeting; and 3) have 
a final draft of the initial mindfulness-based walking training protocol for rollout in Aim 2 within twelve months of 
the first advisory committee meeting. 
 
INCLUSION/EXCLUSION CRITERIA  
Participants with PD will meet the following inclusion criteria:  
• 
diagnosed by a neurologist with idiopathic PD;  
• 
age 50 and older;  
• 
history of freezing of gait;  
• 
able to provide informed consent;  
• 
able to walk independently with or without an assistive device for at least five minutes; and 
• 
experience fear and/or worry in relation to their FOG.  
Care partners of people with PD+FOG will meet the following inclusion criteria:  
• 
able to provide informed consent; and  
• 
able to walk independently with or without an assistive device for at least five minutes.  
Participants with PD will be excluded if they have any of the following:   
• 
evidence of dementia (Mini-Mental Status Examination < 24) to ensure understanding of materials;  
• 
are under consideration for deep brain stimulation surgery within the next three months;  
• 
neurologic condition other than PD;  
• 
inability to cooperate with the protocol;  

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• 
history of orthopedic or other medical problems that limit ability to participate safely in the practice 
sessions; or  
• 
language, visual, or hearing barriers to participation. 
Care partners of people with PD+FOG will be excluded if they have any of the following:  
• 
evidence of dementia (Mini-Mental Status Examination < 24);  
• 
inability to cooperate with the protocol;  
• 
language, visual, or hearing barriers to participation; or 
• 
history of orthopedic or other medical problems that limit ability to participate safely in the practice 
sessions.  
 
 

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Aim 2: Refine and standardize the MBWT protocol to ensure feasibility and acceptability through open 
pilot testing. Twelve people with PD+FOG will participate in the open pilot MBWT program designed in Aim 1. 
After this open pilot the protocol will be modified based on participant feedback, safety, and satisfaction. 
Feasibility elements include meeting benchmarks for: recruitment and randomization; retention and satisfaction; 
delivery of the intervention; participant adherence using technology; evaluating clarity and burden of outcome 
assessments; and monitoring adverse events. 
 
RATIONALE 
Open piloting the MBWT will provide a better standardized MBWT intervention for use in Aim 3. We will be able 
to monitor the group of participants (n = 12) who receive the MBWT intervention and receive their feedback as 
well as input from the mindfulness instructors on how to ensure this intervention is prepared for the randomized 
controlled pilot in Aim 3 and for potential future effectiveness trials.  
 
DESIGN 
The new twelve-week MBWT group intervention will be tested in this aim, with modifications of the MBWT 
program and protocol from the advisory team.   
 
 
After the participants are deemed eligible via the phone screen, they will be scheduled for their first evaluation 
(Time 1). Participants will then attend the pre-program orientation session, followed by the twelve-week MBWT 
program. There will also be a half-day retreat around week nine. Participants will be encouraged to attend all 
classes in-person in our lab space. However, in case of illness or other circumstances that prevent in-person 
attendance, the mindfulness instructor and research team member may speak to the participant to see if 
participating via a video conference platform is feasible, and if the participant is willing and able to do so. 
Participants will then be asked to complete the post-program evaluation (Time 2) and be encouraged to continue 
practicing mindfulness on their own, record practice time, and journal their usual care regimes during a second 
fourteen-week period (the fourteen weeks is to match the time they were in the intervention (pre-program 
orientation + twelve-week program + half-day retreat). They will then return for a follow-up evaluation (Time 3). 
There is not any standardized treatment for FOG, thus having participants record their usual care (i.e., health 
care visits and changes in medications) will provide information for future comparator conditions.  
 
EXPECTED OUTCOMES AND BENCHMARKS – STATISTICAL ANALYSIS PLAN FOR FEASIBILITY STUDY 
In addition to having a standardized version of the MBWT intervention and protocol by the end of year two to 
use in Aim 3, our feasibility aims and benchmarks include: 
Ability to recruit our target sample. We estimate screening approximately 70 participants by phone to find 12 
participants who meet inclusion criteria and agree to participate. These 12 participants will participate in the pre-
program orientation. This anticipated screening rate of 35% is based on our recent interventions. We anticipate 
two people will decide not to participate after attending the pre-program orientation or Time 1 evaluation, leaving 
ten participants. We will track reasons for not continuing during the phone screens. Benchmark: (1) Recruit one 
person for every eight screened. (2) Recruitment of 12 participants. 
Retention of participants and satisfaction with the intervention. We will collect data on why classes are 
missed and reasons for drop-outs, if any. Make up classes may need to be scheduled. The Session Evaluation 
form will provide data for the acceptability and satisfaction of each session. The CSQ will provide acceptability 
and satisfaction data on the program as a whole. Modifications to the protocol will be informed by these two 
measures as well as open-ended questions and exit interviews. Benchmarks: (3) Attendance and retention of 
participants, defined as at least 80% participants attending 80% of the sessions; (4) Session satisfaction defined 
as a minimum average rating of >0.5 on the Session Evaluation Form; and (5) Program satisfaction as a minimum 
average rating of >1.5 on Client Satisfaction Questionnaire (CSQ).  

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Participant adherence. Adherence for home practice will be monitored using a tablet (iPad mini) that will 
prompt the participants daily. The prompts will ask how many minutes they practiced mindfulness today. 
Benchmark: (6) Home practice adherence, at least 70% of participants will complete at least 70% of the daily 
home assignments during the active intervention period. Number of home practice hours is 20 hours over the 
course of the mindfulness intervention.  (7) Maintenance of practice, at least 50% of participants will report 
continued engagement in mindfulness practices during the fourteen-week follow-up period.  
 
INCLUSION/EXCLUSION CRITERIA  
Participants with PD will meet the following inclusion criteria:  
• 
diagnosed by a neurologist with idiopathic PD;  
• 
age 50 and older;  
• 
a score on the Hoehn & Yahr (H&Y) scale between I-IV;  
• 
history of freezing of gait;  
• 
able to provide informed consent;  
• 
able to walk independently with or without an assistive device for at least five minutes;  
• 
experience fear of falling, frustration, irritation, anxiety, and/or worry in relation to their FOG; and 
• 
stable medication regimen for one month prior to enrollment.  
Participants with PD will be excluded if they have any of the following:   
• 
evidence of dementia (Montreal Cognitive Assessment-T < 13) to ensure understanding of materials;  
• 
are under consideration for deep brain stimulation surgery within the next six months or have had DBS 
surgery within the past six months;  
• 
major depression disorder or post-traumatic stress disorder without permission from health provider to 
participate; 
• 
neurologic condition other than PD;  
• 
inability to cooperate with the protocol;  
• 
language, visual, or hearing barriers to participation; or 
• 
history of orthopedic or other medical problems that limit ability to participate safely in the intervention. 
 
 
DATA MANAGEMENT AND POWER ANALYSIS 
Data management resources will include developing forms to use for the feasibility aims and entering data into 
REDCap. Dr. Rawson has experience with development of REDCap databases for multiple studies, enforcing 
standard operating procedures, and data monitoring. She has excellent methods for reducing the potential for 
data errors through smart design of measures and data entry procedures. As this is a feasibility study, a formal 
power analysis was not conducted. We have adopted statistically efficient designs that control for baseline status 
(Aims 2 and 3) and selected measures that are reliable and valid among people with PD. We elaborate on this 
choice in the Statistical Design and Power document. We have a target sample size of 12 people per group 
(allowing for attrition to n = 10) based on previous studies delivering the mindfulness intervention, discussion 
with the mindfulness instructors, recommendations in the MBSR standard operating procedures, as well as our 
knowledge of delivering group-based interventions for people living with PD.  
 
STUDY TIMELINE 
 
Study Milestones 
Year 1 
Year 2 
Year 3 
Obtain IRB Approval 
X 
 
 
Recruit 3-5 Participants to form Advisory Group 
X 
 
 

8 
 
 
 
Advisory Group Committee Meetings 
X 
 
 
Finalize Study Procedures/MBWT Protocol 
X 
 
 
Obtain IRB Approvals on updated Protocol 
X 
 
 
Aim 2: Participant Recruitment for Wave 1 and 2 
X 
 
 
Aim 2: Participant Assessments 
 
X 
 
Aim 2: MBWT Intervention Wave 1 and 2 
 
X 
 
Aim 2: MBWT Modifications after Wave 1 and 2 
 
X 
 
Aim 3: Participant Recruitment (MBWT & UC) 
 
X 
 
Aim 3: Participant Assessments (MBWT & UC) 
 
 
X 
Aim 3: MBWT Intervention and UC 
 
 
X 
Aim 3: MBWT Modifications  
 
 
X 
Feasibility Reports 
 
 
X 
Dissemination via Manuscript Submission 
 
 
X 
Submission of Subsequent Grant Application  
 
 
X 
Abbreviations: MBWT, Mindfulness Based Walking Therapy; UC, Usual Care 
 
STUDY TIMELINE JUSTIFICATION 
The first year of the study will be devoted to obtaining IRB approval, forming the advisory committee, and 
creating the first draft of a MBWT program by modifying the standard MBSR protocol to focus more specifically 
on walking (Aim 1). In the second year, we will conduct the open pilot study (Aim 2), allowing time between 
waves to evaluate results and make adjustments to the MBWT intervention after each iteration. The final year 
will be devoted to piloting of the finalized MBWT intervention and comparing it to usual care in a randomized 
controlled pilot study (Aim 3). We will utilize results obtained to inform future effectiveness trials and 
mechanistic studies and plan to submit a grant to support the next steps in this line of research by the end of 
the third year.

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