Mindfulness-Based Stress Reduction to Improve Neuropsychological Functioning in Acquired Brain Injury
Phase: NA
Conditions: Stroke
Sponsor: VA Office of Research and Development

Study Protocol Cover Page 
Study Title: Mindfulness-Based Stress Reduction to Improve Neuropsychological Functioning in 
Acquired Brain Injury 
Clinical Trials ID: NCT03969563 
Document date/IRB approval date: 10/31/2019 

Treatment Protocol 
We conducted six rounds of each class (see Table 2 for course topics and descriptions). 
To reduce variability, both courses had the same instructor - a trained and certified MBSR 
instructor with over 10 years of experience and a Master’s degree in Education (emphasis on 
Curriculum and Instruction) - making her well-qualified to teach both classes. The instructor also 
received specialized training for teaching MBSR and other educational courses online. Both 
classes were further matched in terms of the length (2.5 hours/week), schedule (9-week class 
plus a day-long retreat), class size (7-10 participants), instructor, and amount of homework. All 
participants were also informed at the beginning of the course that their data would be excluded 
from the study if they missed more than three classes. 
The MBSR class was the standardized program created by the University of 
Massachusetts, which includes an introductory session, 8 weeks of classes, and a retreat during 
the sixth week (Kabat-Zinn, 1990b). During the course, participants learned about mindfulness 
through practices such as body awareness, mindful movement, meditation, and informal 
mindfulness practices of daily life (e.g., eating, communicating, working, coping). The retreat 
included a review of class material, meditation and yoga practice, and a group lunch. Our study 
modified this program slightly by reducing the retreat day to four hours. And, given the 
population and the course modality, participants completed smaller movement and chair yoga 
exercises instead of the standard yoga practices. For homework, MBSR participants were 
assigned practices according to the standard MBSR curriculum, where they followed along to 
different meditation recordings (provided to them through a web link), engaged in mindful 
movement, and read from the course manual. The time spent engaging in mindfulness practices 
were then tracked using online homework logs.  
Our active intervention, the Brain Health class, was a modification of an existing VA 
education class for brain-injured individuals taught on the VA campus. It served as a robust active 
control because it matched the MBSR intervention in terms of instructor, time interacting with 
peers and the instructor, movement, schedule, and homework activities. The Brain Health class 
did not include any meditative/ mindfulness components, which we hypothesized would be the 
critical factor for how MBSR leads to improved health and cognition (Kabat-Zinn, 1990b). 

Specifically, each class consisted of lectures with slides and videos (90 mins) and a group 
discussion (45 mins), during which time participants learned basic brain anatomy, how brain 
injuries can affect their cognition, and completed classes on the importance of topics such as 
sleep, nutrition, and social connection. To match the movement portion of the MBSR class, the 
Brain Health class also included simple chair exercises, such as stretching and reaching. The Brain 
Health retreat consisted of a review of class topics, short videos on brain topics, and a group 
lunch.    
Measures  
Study Implementation and Satisfaction. We measured study feasibility by examining rates of 
recruitment (i.e., the percentage of participants who agreed to take part in the study, 
relative to the total number of people we contacted) and retention (i.e., how many 
participants completed the program, attendance, homework engagement, and instructor-
rated class engagement). Participants were also asked to complete an anonymous nine-item 
questionnaire created by the authors (see Table 3) to assess course satisfaction. Participants 
thus used a scale of 1 (very unsatisfied) to 5 (very satisfied) to answer questions such as, “How 
satisfied were you with the class?” and “How likely are you to continue to study and practice 
the skills you learned in this class?”. 
Mood, Well-Being, and Health. The Geriatric Depression Scale (Yesavage et al., 1982) was 
administered to measure subjective symptoms of depression in an older adult population. 
Participants indicated yes (1) or no (0) to questions such as, “Do you feel happy most of the time?” 
and “Do you feel your situation is hopeless?”. The State-Trait Anxiety Inventory (Spielberger et 
al., 1983) measured current anxiety symptoms.  Participants used a 1 (almost never) to 4 
(almost always) scale to express how often they “feel content,” and “feel calm.”