"Optimizing Wellness and Neurorehabilitation with Mindfulness (OWNMindfulness)": feasibility of a novel mindfulness-based rehabilitation intervention for Persisting Symptoms after Concussion.

“Optimizing Wellness and Neurorehabilitation with Mindfulness (OWNMindfulness)”: Feasibility of a Novel Mindfulness-based Rehabilitation Intervention for Persisting Symptoms After Concussion - PMC Skip to main content An official website of the United States government Here's how you know Here's how you know Search Log in Primary site navigation Search Log in Search PMC Full-Text Archive Search in PMC Journal List User Guide As a library, NLM provides access to scientific literature. Inclusion in an NLM database does not imply endorsement of, or agreement with, the contents by NLM or the National Institutes of Health. Learn more: PMC Disclaimer | PMC Copyright Notice Disabil Rehabil . Author manuscript; available in PMC: 2026 Jun 1. Published in final edited form as: Disabil Rehabil. 2024 Nov 12;47(13):3410–3420. doi: 10.1080/09638288.2024.2423783 “Optimizing Wellness and Neurorehabilitation with Mindfulness (OWNMindfulness)”: Feasibility of a Novel Mindfulness-based Rehabilitation Intervention for Persisting Symptoms After Concussion Brenda C Lovette 1 , Kathleen Doyle Lyons 1, 2 , Jonathan Greenberg 3, 4 , Ruth Palan Lopez 1, 5 Author information Article notes Copyright and License information 1 Department of Rehabilitation Sciences, MGH Institute of Health Professions, Boston, Massachusetts, USA. 2 Department of Occupational Therapy, School of Health and Rehabilitation Sciences, MGH Institute of Health Professions, Boston, MA, USA 3 Center for Health Outcomes and Interdisciplinary Research (CHOIR), Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA. 4 Department of Psychiatry, Harvard Medical School, Boston, MA, USA. 5 School of Nursing, MGH Institute of Health Professions, Boston, Massachusetts, USA. ✉ Corresponding Author: Brenda C. Lovette, MS, CCC-SLP; Department of Rehabilitation Sciences, MGH Institute of Health Professions, Boston, MA, 02114; blovette@mghihp.edu Issue date 2025 Jun. PMC Copyright notice PMCID: PMC12066800  NIHMSID: NIHMS2032557  PMID: 39530473 The publisher's version of this article is available at Disabil Rehabil Abstract Background: Persisting Symptoms after Concussion (PSaC) are common and difficult to treat. Mindfulness-based interventions can support recovery but are rarely included in rehabilitative care. We developed OWNMindfulness , an eight-week live-video mindfulness-based group for PSaC. Purpose: To assess feasibility and preliminary clinical effects of OWNMindfulness. Methods: Fourteen individuals with PSaC enrolled in this mixed-methods single-arm feasibility study. We assessed enrollment/retention, adherence, fidelity, instrument completion, safety, and satisfaction. We evaluated preliminary trends in the impact of the intervention on mindfulness (CAMS-R), concussion symptoms (PCSS), and QOL (WHOQOL-BREF). Qualitative analysis of exit interviews explored participants’ perceptions of the effects of the intervention, and framework analysis assessed adequacy of the quantitative measures to capture perceived effects. Results: Feasibility results met a priori benchmarks. Mindfulness, concussion symptoms, and QOL scores improved (CAMS-R: adjusted p =0.01, large effect size; PCSS: adjusted p =0.03, moderate effect size; WHOQOL-BREF: not significant, small effect size). Qualitative analysis of interview data found benefits including validation, compassion, self-awareness, self-efficacy, concussion symptoms, resilience, life participation, social relationships, and QOL. Framework analysis demonstrated that quantitative tools captured change in concussion symptoms but did not comprehensively assess the other benefits identified through qualitative methods. Conclusions: OWNMindfulness shows preliminary feasibility and promise for improving clinical outcomes. Results suggest the need for additional quantitative tools for comprehensive measurement of the effects, and may point to potential mechanisms of action. Keywords: Brain Injuries, Traumatic, Concussion, Mindfulness, Rehabilitation, Feasibility Mild traumatic brain injuries (mTBI), also known as concussions, are common [ 1 – 3 ] and symptoms can affect multiple domains of function [ 4 ]. While the exact prevalence of Persisting Symptoms after Concussion (PSaC) is not fully understood, some studies indicate that over half (64%) of people with mTBI have symptoms that persist three months post injury [ 5 ], and up to 44% have symptoms that persist a year after injury and beyond [ 6 – 8 ]. Living with PSaC can profoundly affect employment, academics, social relationships, daily function, and overall life satisfaction [ 6 , 7 , 9 , 10 ]. Mindfulness is a state of heightened awareness, attention, and acceptance of the present moment [ 11 ]. Mindfulness-based interventions are programs that help participants develop mindfulness skills, and can promote wellness by enhancing positive emotional states and self-regulated behavior [ 12 ] in both general and clinical populations [ 13 – 15 ]. Mindfulness-based interventions have shown promise in supporting recovery from mTBI [ 16 , 17 ]. Mindfulness is associated with improved neuroplasticity [ 18 , 19 ], and can impact brain areas and functions which have important implication for mTBI such as the default mode network [ 20 ], amygdala [ 21 ], and frontal lobes [ 22 ]. Mindfulness-based interventions have been shown to affect a broad variety of clinical domains [ 23 , 24 ] and positively impact several key persistent concussion symptoms such as pain [ 25 ], cognition [ 26 ], emotion regulation [ 27 ] some of which are not directly targeted by standard rehabilitation care (e.g., coping skills, sleep) [ 17 ]. Importantly, mindfulness-based interventions can help address the psychosocial factors involved in symptom persistence, such as anxiety and depression [ 28 ]. However, there is a lack of consensus on the optimal dosage and format of mindfulness-based interventions for this population [ 16 ] and there is no standard mindfulness-based intervention for the treatment of this population. Further, to our knowledge, no interventions explicitly integrate mindfulness principles with evidence-based concussion rehabilitation principles (i.e., decreased activity tolerance, cognitive challenges, physical limitations and pain, etc.) and potentially boost their rehabilitative impact. Despite their potential to support recovery, very few TBI clinics integrate mindfulness-based programs into their services [ 29 – 31 ]. Several obstacles may be at play, including clinic infrastructure and clinicians’ readiness to deliver such interventions [ 32 ]. To address this gap, we developed OWNMindfulness (Optimizing Wellness and Neurorehabilitation with Mindfulness) , a novel mindfulness-based intervention for delivery in a clinical education setting. Designing OWNMindfulness for the clinical education setting and incorporating interdisciplinary graduate students in the intervention aimed to address accessibility barriers, and potentially boost the potency of the intervention. We conducted this feasibility study in preparation for a clinical efficacy trial. Assessment of feasibility and preliminary effect is necessary before moving on to large-scale efficacy testing to evaluate recruitment and retention, test study procedures, and confirm that participants find value in the intervention [ 33 ]. Further, given the wide range of possible meaningful effects associated with mindfulness-based interventions for people with mTBI, it is essential to investigate the adequacy of measures to capture the clinical benefits of the program. Mixed-methods framework analysis is an ideal method for this type of evaluation because it provides a way to combine validated quantitative tools with participants experiences to obtain a more integrative and comprehensive understanding of findings and thus best inform intervention evaluation and development [ 34 ]. The primary purpose of this mixed-methods, single-arm, repeated measures study was to evaluate key indicators of feasibility [ 35 ] including 1) enrollment/retention; 2) adherence: attendance and home program; 3), fidelity, 4) ability to complete measures; and 5) safety and satisfaction. Second, we aimed to evaluate preliminary trends in the impact of the intervention on mindfulness (intervention target), concussion symptoms (primary outcome), and quality of life (QOL) (secondary/distal outcome). Finally, we set out to explore participants’ perceptions of the effects of the intervention and the adequacy of the quantitative measures to capture those effects to inform future quantitative measures, in preparation for a future efficacy trial. MATERIALS AND METHODS Setting and Participants We conducted this feasibility study at the MGH Institute of Health Professions (MGH IHP), in Boston, MA. See Figure 1 for a flow chart detailing study procedures. MGH IHP is a clinical education center where graduate students of the health professions (nursing, occupational therapy (OT), physical therapy (PT), and speech-language pathology (SLP)) offer supervised interdisciplinary team-based care to the community free of charge. Clinical faculty identified students from the graduate programs to participate as student coaches as part of their clinical training experience. These students then underwent approximately five hours of training on mindfulness-informed rehabilitation for people with mTBI delivered through synchronous and asynchronous workshops, assigned reading, and direct supervision by the PI. We assigned each student coach to work with a study participant. Figure 1: Study Procedures. Open in a new tab We recruited participants between July 2023 to September 2023 utilizing our network of referral partners comprised of rehabilitation clinicians (PT, OT, SLP, social workers, nurse practitioners, neurologists, and counselors) actively engaged in treating individuals with mTBI. Clinicians handed informational study flyers to patients with persistent symptoms after mTBI and invited them to contact us via the study email address. The PI then had a telephone conversation with interested potential participants to screen for the following inclusions criteria: adults over the age of 18, fluent in English, with self-reported history being diagnosed with of at least one mild traumatic brain injury by a medical provider, with that injury having occurred at least three months before but not more than five years before enrollment, currently reporting persistent symptoms of that injury, who had access to a computer or internet capable smart device, could complete online forms independently, and were willing to consent to participation in research. Regarding time post injury, we excluded individuals whose injury was more than 5 years ago to reduce the risk of reported symptoms being due to causes unrelated to the concussion. We also excluded those who reported currently meditating 45 minutes per week or more to avoid confounding results [ 36 ]. Positionality Statement The authorship team comprised a multidisciplinary group of health scientists. The primary author and investigator was a speech-language pathologist with over a decade of clinical experience in concussion management. The project was a key component of their doctoral dissertation research. The co-authors served as mentors for study design and analysis and represent the fields of occupational therapy, psychology, and nursing. The team brought a range of experience in intervention development and testing, qualitative and mixed methods research, mind-body medicine, and concussion management. Study Procedures Participants received a unique link to a HIPAA compliant web-based application (REDCap) [ 37 ] where they completed a demographic survey and measures of trait mindfulness, concussion symptoms, and QOL (see Measures ) one week prior to the program (baseline) and one week after the intervention (post). We conducted periodic data checks to identify missing data and contacted participants during the study period as needed to complete missing items. For qualitative data collection, the interventionist conducted a ~60-minute exit interview on Zoom with each participant within a month of program completion. Mass General Brigham IRB approved this study and all participants provided consent via electronic form during enrollment. All procedures comply with the tenets of the Declaration of Helsinki. Description of The Intervention We developed the OWNMindfulness program using principles by integrating mindfulness principles commonly emphasized in Mindfulness Based Stress Reduction (MBSR)[ 38 ] (i.e., attention, present focus, awareness, acceptance, and non-judgment) [ 39 ] with concussion neurorehabilitation principles (i.e., symptom management and confrontation [ 40 , 41 ], accommodations [ 42 , 43 ] (i.e., instructions for pacing, and vision and memory accommodations), individualized goal setting with an emphasis on daily function [ 44 , 45 ], cognitive rehabilitation techniques, [ 46 – 48 ], education on neuroplasticity, [ 49 ] and social support, [ 50 ]). The PI, who was also the primary interventionist, was a rehabilitation clinician (SLP and Certified Brain Injury Specialist) and mindfulness instructor, educated through the UCSD Center for Mindfulness Professional Training Institute. The OWNMindfulness program consisted of eight weekly live-video (telehealth) sessions, each centered on a mindfulness and neurorehabilitation theme. An overview of the curriculum, including themes and mindfulness techniques, is displayed in table 1 . Each session included didactics, an experiential exercise, a facilitated small group discussion held in breakout rooms, guided meditation, and home practice assignment. In addition to these weekly group sessions, each participant was paired with a student coach who met with the participant weekly to reinforce the curriculum content, discuss progress, and offer guidance on how to incorporate mindfulness into their daily routines. Students were given written instructions on how to structure the coaching sessions which included a) check-in, b) review of group session content, c) discussion of home program experiences, and d) practice guided meditation together and reflect. Table 1: Program Content and Structure Week Content Home Program 1 Introduction to Mindfulness Meditation Breath awareness Daily 5-minute guided meditation (breath awareness) Teach a friend the definition of mindfulness 2 Attention as a “Muscle” Body scan Daily 10-minute guided meditation (body scan) Use mindfulness bell 3 Thoughts and Judgements Chair yoga Daily 15-minute guided meditation (chair yoga) Notice pleasant and unpleasant experiences, thoughts, and emotions 4 Being With Walking meditation and breath awareness Daily 20-minute guided meditation Use RAIN * strategy 5 Self-Regulation Body scan Daily 20-minute guided meditation Use Non-violent communication 6 Presence in Daily Life Raisin meditation Daily 20-minute guided meditation Mindful eating, bathing, or other 7 Connectedness and Compassion Loving kindness meditation Daily 20-minute guided meditation Listen from the heart activity 8 Resilience Open awareness meditation Daily 20-minute guided meditation Open in a new tab * Note: RAIN is a mindfulness-based emotion regulation with the following four steps Recognize, Allow, Investigate, and Non-self-identify or Nurture. Measures Feasibility Measures To evaluate feasibility, we collected data to evaluate recruitment/retention, participant adherence, fidelity, measurement completion, satisfaction, and safety. We defined a priori benchmarks based on established guidelines including NIH guide for pilot studies [ 35 , 51 ] and similar published feasibility studies [ 36 , 52 – 54 ]. We aimed to enroll 12 participants, based on pragmatic capacity of the group format[ 55 ], participant feedback after previous pilots, and aligning with prior open pilot feasibility studies[ 36 , 53 ] (see table 3 ). To evaluate recruitment, retention, and participant adherence to the group meetings we collected attendance logs. A team of research assistants recorded attendance for each weekly group session, considering participants present if they logged in during the session. The log also documented those who formally dropped out, along with their reasons for doing so. To measure adherence to home program, graduate student coaches logged the number of days participants self-reported home program participation during their one-on-one sessions. Home program was considered “complete” for a given day if the participant practiced meditation for any amount of time. To measure fidelity, during the live-video sessions a research assistant recorded each planned curriculum element on a binary checklist (either delivered or not delivered). To assess measurement completion, we counted the number of completed surveys at the end of the study. To measure satisfaction, after the intervention, participants completed the Client Satisfaction Questionnaire – 8 (CSQ-8) [ 56 ], an eight-item survey which asks participants to rate their satisfaction with a service on a four-point Likert scale. CSQ-8 scores range from 8 to 32, with a midpoint of 20. To evaluate safety, as part of the weekly check in, we instructed the graduate students to ask participants about any negative events and immediately report to the PI to be documented and addressed as indicated. Table 3: Feasibility Measures, Benchmarks, and Results Domain Operationalized Measure A Priori Feasibility Benchmarks Result Qualifier Enrollment and Retention Number of consenting participants who enrolled Excellent: 12 participants enrolled Good: 10 participants enrolled 14 enrolled Excellent The percent of participants who complete the intervention (do not formally withdraw, attend most sessions, and complete post program measures) Excellent: >80% of participants complete the intervention Good: >70% of participants complete the intervention 85.71% (12) completed Excellent Participant adherence Session attendance Excellent: >70% of participants complete 5 of 8 sessions Good: >50% of participants complete 5 out of 8 sessions 91.67% completed 5 of 8 sessions Excellent Home program completion. Number of days participant reported completing meditation Excellent: >70% of participants complete 70% of home program Good: >70% complete 50% of home program 67% of participants completed 70% of home program 75% of participants completed 50% of home program Good Fidelity Fidelity checklist Excellent: >90% of intervention components delivered Good: >80% of intervention components delivered 100% of intervention components delivered Excellent Instrument completion Number of completed measures Excellent: 100% item completion rate Good: >90% item completion rate 100% of items completed Excellent Satisfaction and Safety Client Satisfaction Survey [ 56 ] Excellent: >80% of participants scored satisfaction above the midpoint of the scale (score: 20) Good: if >70% 91.67% scored above the midpoint Excellent Participant-reported adverse events Excellent: No adverse events Good: minimal or mild events in less than 10% of participants No adverse events reported Excellent Open in a new tab Quantitative Outcome Measures To evaluate trait mindfulness we used the Cognitive and Affective Mindfulness Scale – Revised (CAMS-R) [ 57 ], a 12-item instrument scored on a four-point Likert scale where higher scores reflect greater mindfulness. This measure has demonstrated acceptable internal consistency (α = .74). To assess concussion symptoms we used the Post-Concussion Symptom Scale (PCSS) [ 58 ]. This is a 21-item instrument that asks respondents to indicate the presence and severity of post-concussion symptoms on a seven-point Likert scale where higher number indicates greater severity. The instrument demonstrates high internal consistency, test-retest reliability, [ 59 ] and criterion validity for people with mTBI [ 60 ]. To determine QOL, we administered the World Health Organization Quality of Life Scale (WHOQOL-BREF) [ 61 ]. This is a 26-item self-reported survey that asks respondents to rate their perceptions of their health and well-being on a five-point Likert scale where a higher number indicates greater QOL. This measure probes respondents’ ratings of physical health, psychological health, social relationships, and environment. The WHOQOL-BREF has demonstrated strong content validity, internal consistency, and test–retest reliability in general populations, [ 62 , 63 ] and for people recovering from brain injury [ 64 ]. Exit Interviews The PI conducted exit interviews with the participants who completed the intervention (N=12) to explore their perceptions of the effects of the intervention. We used an interview guide that consisted of open-ended questions addressing domains of outcomes reported in the literature including somatic, symptoms, cognitive symptoms, emotional symptoms, sleep, coping, and daily life and function [ 17 ]. Probes such as “tell me more” or “what do you mean by that” were used to encourage participants to delve more deeply into their experiences. The interview audio was transcribed by Zoom software. The interviewer proofread the transcript while listening to the recording and edited it to deidentify the transcripts and ensure accuracy. Data Analysis We used descriptive statistics to calculate participant demographics, enrollment, attendance, fidelity, safety, and satisfaction. We used content analysis to analyze the open text demographic item. To assess the effect of the intervention on the hypothesized intervention target (mindfulness) and outcome measures (concussion symptoms and QOL) we used non-parametric Friedman’s test given the non-normality of the scores. The resulting p values were adjusted for multiple tests using the false discovery rate (FDR) adjustment. We used Kendall’s W to estimate the effect sizes. To explore the participants’ perceived effects of the intervention and adequacy of the quantitative tools to capture these benefits, we complete a two-step mixed-methods analysis. First, we analyzed interview transcripts using a hybrid deductive-inductive approach to thematic analysis [ 65 , 66 ]. The approach was deductive in that we used a set of a-priori codes based on literature on mTBI symptom domains (i.e., somatic, cognitive, and emotional) and results from prior studies on mindfulness for mTBI including a scoping review which investigated outcome measurement [ 17 ], and inductive in that we identified novel codes directly from the data. The qualitative analysis team (BCL, RPL) included two clinical scientists from the fields of SLP and nursing, both with training and expertise in qualitative methods and rehabilitation. We maximized rigor of qualitative data analysis by first having the team code one third of the data independently and then meet to compare results and develop a codebook. The team subsequently coded the remainder of the data, meeting periodically to compare results and resolve discrepancies. Finally, the team engaged in a series of collaborative discussions to identify themes and relationships between themes. Next, we conducted framework analysis to systematically examine the degree of overlap and agreement between the qualitative and quantitative results. [ 34 ] We created a matrix and displayed the qualitative findings (themes) describing the participants’ perceived effect of the intervention across the columns and displayed the quantitative instruments across the rows. We placed an X at the intersection of the row and column if both qualitative results and quantitative constructs were aligned. Finally, we examined the columns and rows to identify patterns in the data. (see figure 2 ) Figure 2: Framework Analysis. Open in a new tab Note: CAMS-R = Cognitive Affective Mindfulness Scale, Revised; PCSS = Post-concussion Symptom Scale, WHOQOL = World Health Organization Quality of Life Scale, Brief Form. RESULTS The sample consisted of 14 individuals. The average age was 49.21 (SD=13.28) years. The majority were female (93%), white (71.4%), and educated (100% some college or higher). Six had concussion symptoms for three months to one year (42.9%), five for one to two years (41.6%), and three for two to five years (21.4%). Participants indicated a variety of concussion providers as their referral sources including rehabilitation therapists (PT/OT/SLP), specialized nurse practitioners, neurologists, and “other” (e.g., social work, counselor, other). Mental health conditions (depression and anxiety) and neurodiversity (ADHD) were prevalent in our sample. Most participants were actively engaged in other rehabilitation care at the time of their participation. Additional demographic information presented in table 2 . Table 2: Demographics (N=14) Variable n (%) Age in years, M (SD) 49.21 (13.28) Gender Males 1 (7.1) Females 13 (93) Race White 10 (71.4) Black 2 (14.3) Asian 1 (7.1) Hispanic/Latino 1 (7.1) Highest education level completed Some college 3 (21.4) College degree 8 (57) Graduate degree 3 (21.4) Employment Employed full time 5 (41.6) Employed part time 2 (14.3) Unemployed 1 (7.1) Retired 1 (7.1) Unable to work 5 (41.6) Marital status Single 3 (21.4) Married/Domestic Partner 4 (28.6) Separated/Divorced/Widowed 7 (50) “I consider my household income…” Not enough 7 (50) Just enough 4 (28.6) Comfortable 3 (21.4) Tried meditation in the past No 3 (21.4) Yes, but fewer than 5 times 7 (50) Yes, but not since injury 2 (14.3) Yes, but <45 min per week 2 (14.3) Multiple traumatic brain injury episodes No 8 (57.1) Yes 6 (42.9) Months since most recent mild traumatic brain injury 3 to <12 months 6 (42.9) 1 to <2 years 5 (41.6) 2 to <5 years 3 (21.4) Self-reported cognitive, psychiatric, and mental health comorbidity Attention-deficit hyperactivity disorder 6 (42.9) Depression 8 (57.1) Anxiety 12 (85.7) Other mental health disorder 4 (28.6) Referral Source * Rehabilitation Therapist (PT, OT, SLP) 5 (41.6) Concussion Center Provider (specialized nurse practitioner) 5 (41.6) Neurologist 1 (7.1) Other (e.g. counselor, social worker) 2 (14.3) Receiving other treatments concurrent with participation in this study * Physical Therapy 8 (57.1) Occupational/Vision Therapy 5 (41.6) Speech Language Pathology/Cognitive Therapy 9 (64.3) Chiropractic 2 (14.3) Acupuncture 1 (7.1) Counseling 9 (64.3) Other 4 (28.6) None 1 (7.1) Participant goals * Symptom management/improvement 10 (71.4) Relaxation and coping 5 (41.7) Improve focus 2 (14.3) Not sure 1 (7.1) Open in a new tab Note : * results add to more than 100% as some participants indicated more than one recruitment source, concurrent therapy, or goal Feasibility Feasibility benchmarks and results are presented in table 3 . Fourteen individuals enrolled in the study, meeting our enrollment goal of 12 participants. Two dropped out and twelve completed the intervention (85.71%), signifying excellent retention. One participant withdrew after one session due to scheduling related to return to work, a second participant withdrew after five sessions due to an unrelated medical issue. Participant adherence was excellent. Most participants attended six or more sessions. Two participants attended five sessions, and one attended four sessions. Of note, all 12 completers attended the final session. Adherence to the home program varied from a maximum of 55 practice times (out of a possible 56) to a minimum of 13 times (M = 39.67 times). Most participants (75%) completed the home program more than half of time which met our criteria for good adherence. Fidelity to the intervention was 100% for all four program components which met criteria for excellent fidelity. At the end of the study period, survey completion was 100% with no missing data, excellent per our benchmarks. Participant satisfaction, measured by CSQ-8, ranged from 18 to 32 (Mdn = 30.5, M= 28.75, SD = 4.56). Eleven of the 12 completers scored above the test midpoint score (20 points) meeting our criteria for excellent satisfaction. There were no adverse events reported during the study period, meeting criteria for excellent safety. Change in Quantitative Measures Descriptive statistics for each outcome are presented in table 4 . There was a significant increase in mindfulness (CAMS-R), after multiple testing correction ( nominal p =0.004, adjusted p =0.01) The effect size was large (Kendall’s W =0.69). There was a significant decrease in concussion symptoms (PCSS), after multiple testing correction ( nominal p=0.02, adjusted p =0.03). The effect size was moderate (Kendall’s W =0.44). The change in QOL (WHOQOL-BREF) was in the positive/hypothesized direction, but not significant ( p > 0.05). The effect size was small (Kendall’s W =0.0075). Table 4: Quantitative Results Scale Baseline Mean (SD) Range Median Post-intervention Mean (SD) Range Median Friedman Test Statistic Nominal p value Adjusted p value Effect size Kendall’s W CSQ-8 n/a n/a n/a 28.75 (4.56) 18–32 30.2 n/a n/a n/a n/a CAMS-R 30.25 (2.83) 26–35 30.5 33.67 (3.60) 30–40 33.67 8.33 0.004 0.01* Large (0.69) PCSS 56.25 (21.34) 21–84 61.5 45.83 (29.93) 9–98 43.5 5.33 0.02 0.03* Moderate (0.44) WHOQOL-BREF 68.25 (12.39) 43–89 70 71.08 (16.98) 42–94 71.5 0.09 0.76 0.76 Small (0.0075) Open in a new tab Note: CSQ-8 = Client Satisfaction Questionnaire – 8; CAMS-R = Cognitive Affective Mindfulness Scale, Revised; PCSS = Post-concussion Symptom Scale, WHOQOL = World Health Organization Quality of Life Scale, Brief Form. Perceived Effects and Adequacy of Quantitative Measures In response to open-ended questions about their perceptions of the intervention, all participants described experiencing multiple benefits, which we observed as following a distinct pattern. They reported a set of interconnected positive experiences as a result of the intervention, including feelings of validation , compassion , self-awareness , and self-efficacy . These appeared to serve as catalysts to two outcomes, a sense of resilience and a reduction in concussion symptoms . Ultimately, these positive emotional and outcome-related processes appeared to lead to enhanced life participation , improved social relationships , and an overall increase in their quality of life . We detail the process below. (See figure 3 ) Figure 3: Qualitative Results. Open in a new tab Alt Text: Three columns of circles with arrows between each row. The first titled Interconnected Experiences and four circles include the words validation, compassion, self-awareness, and self-efficacy. The second titled Primary Outcomes, two circles include the words resilience and concussion symptoms. Third titled Secondary Outcomes includes one circle with the words life participation, social relationships, and QOL. Our analysis suggested that the four interconnected experiences, validation, compassion, self-awareness, and self-efficacy, unfolded in the following manner. All participants described a sense of validation derived from participating in the program, which we observed as feeling of being acknowledged and understood through external feedback that affirmed their feelings and experiences. Participants described “relief” upon hearing others’ similar experiences, “knowing I’m not alone” and feeling that “I am not going crazy.” This validation fostered compassion for others and themselves and helped highlight the ways “giving [them] self grace” supported recovery. Practicing compassionate pauses and mindfulness in their daily lives helped promote self-awareness , allowing them to notice “my body sending out the signals” including overwhelm and increased symptoms. Participants indicated that this helped them notice opportunities to “focus, recompose, or let [symptoms] come down enough to handle the situation,” thus building greater self-efficacy for managing symptoms, allowing them to feel “a bit in control and a bit optimistic.” In turn, all participants reported that their sense of self-efficacy for managing concussion symptoms and recovery improved. All participants reported improvements in one or more concussion symptoms which fell into four types – somatic, cognitive, and emotional symptoms, and sleep . Improvements to somatic symptoms included reduced severity and frequency of headaches, migraines, back and neck pain, fatigue, improved noise tolerance. Improvements in cognitive symptoms included better “mental clarity,” “focus and avoiding distractions,” verbal expression, and memory. Improvements in emotional symptoms included feeling less stress and less anxiety. Improvements in sleep included improved sleep quality and duration and strategies for managing sleep challenges. One participant reported that the intervention provided them with a tool to deal with their unstable moods. Another participant described how the intervention, and the mindfulness practice, gave them “a reprieve from the dark places [PTSD related thoughts]”). They also described improved ability to acknowledge or face their situation, accept things as they are, and adapt or move forward which we labeled as resilience. Participants explained how acknowledging “I’m not where I want to be, but I’m able to take a breath and see, okay, here are areas where I am better or I am making progress.” They described “finding that acceptance piece, I know I cannot go back, so I can only go forward,” and feeling that the “tools are making life a little better, or allowing me to partake and be present in my life more.” One participant described “I didn’t have hope before… I felt like I was in a tunnel that had no space, no room, and no entrance or exit. That’s what I felt like. I don’t feel like that anymore. I found a new way.” Ultimately, these improvements led to perceived improved life participation and social relationships . Participants described returning to work, resuming hobbies such as quilting, reengaging in their social networks, and finding more ease with driving. Some noted improved communication and conflict resolution in parenting. Several participants described how mindfulness strategies helped them feel more able to tolerate gatherings, and generally enjoy their lives more. One participant said, “the quality of my life is better because I’m not just on autopilot.” Framework analysis confirmed that the PCSS captured the reduction in concussion symptoms that participants described in the qualitative findings including somatic, cognitive, and emotional symptoms, and sleep. The WHOQOL-BREF captured quality of life and provided some indication of social relationships , though indirectly. Analysis demonstrated that none of the quantitative tools measured validation, compassion, self-awareness, self-efficacy, resilience, and life participation. (See figure 2 ) DISCUSSION We conducted this mixed-methods, single-arm, repeated measures study to evaluate key indicators of feasibility. We also assessed preliminary trends in the effects of the intervention on trait mindfulness, concussion symptoms, and QOL, and explored participants’ perceptions of the effects of the intervention and the adequacy of the quantitative measures to capture those effects. The study design met all a priori feasibility benchmarks. Unlike other studies of mindfulness interventions for those with neuro diagnoses,[ 16 , 17 ] our sample included individuals with a history of mTBI (and not those with more severe TBI or other neurological diagnoses).We exceeded our goal for enrollment and met our goal for retention. Participants reported a variety of referral sources including rehabilitation clinicians and specialized concussion clinic nurse practitioners, one indicated neurologist. This finding suggests an opportunity to educate neurologists and primary care providers about programs such as this to boost accessibility for eligible individuals. Participant attendance met our goal for excellent and home program met our goal for good adherence. Fidelity and instrument completion were excellent. Satisfaction was good, suggesting strong acceptability and value among our target population, and there were no reported adverse events. These results affirm the feasibility and fit of the intervention and study protocol, and support readiness for conducting a larger scale efficacy study. Of note, mental health comorbidities were common in our sample, which is aligned with previous research indicating that factors such as anxiety and depression are common post-concussion and can play role in recovery. Future efficacy studies should systematically test for the interplay of these conditions with outcomes. The only feasibility measure falling short of excellent was home adherence to program completion. Recent research has an inconclusive stance on the impact and importance of daily mindfulness practice in achieving positive outcomes. Studies suggest that the dosage and frequency of mindfulness practice may not significantly impact results, [ 67 ] and the effects of daily mindfulness practice appear to be time-limited [ 68 ]. Despite these findings, interventionists persist in incorporating home practice components into programs, highlighting a continued interest in exploring its potential benefits. Further study is needed to determine the effect of the various elements of our intervention (e.g., weekly attendance, one-on -one coaching, and home program completion) for realizing the benefits of this intervention. In line with common guidelines for feasibility studies [ 69 , 70 ], this study evaluated trends in effects and associated effect sizes to determine whether there is potential clinical value that warrants further investigation in future research. We found significant improvements in trait mindfulness with a large effect size, and concussion symptoms with a moderate effect size, and a smaller effect on QOL, suggesting preliminary evidence of positive effect. These results are preliminary and should be interpreted with caution given our small sample size and lack of control group. Nonetheless, they show promise in light of evidence indicating that Persisting Symptoms after Concussion (PSaC) often remain stable [ 1 , 71 ], and that common nonpharmacological interventions for this population often fail to yield symptom improvement [ 72 , 73 ]. Analysis of interview data demonstrated a series of interconnected experiences of validation, compassion, self-awareness, and self-efficacy, improvements in all domains of concussion symptoms, resilience, QOL, life participation and social relationships. We conceptualized these perceived benefits as a series of phases which fit into a model of functional recovery, beginning with the four experiences as potential mechanisms of action, followed by primary outcomes (resilience and concussion symptoms), and culminating in secondary effects including meaningful enhancements in life participation. Subsequent studies should systematically evaluate these proposed mechanisms of action and their relationship to clinical outcomes. Our study was conducted in a group setting and participants’ emphasis on validation may suggest a key active ingredient in the intervention. The importance of validation, namely feeling understood and believed in one’s experience living with PSaC, aligns with its recognized significance in concussion treatment [ 74 ] and other populations such as chronic pain [ 75 , 76 ], often called an “invisible injuries.” Results underscore the potential of validation, in this case among peers with a shared experience, amplified by the strengths based and acceptance focused tone of the mindfulness intervention, as critical factor contributing to the effectiveness of the intervention and may point to an informative control condition for future studies. Framework analysis demonstrated that our quantitative instruments captured QOL, social relationships, and all types of concussion symptoms reported by the participants. Participants perceived improvements in life participation, which were not directly measured. The Canadian Occupational Performance Measure (COPM)[ 77 ] facilitates individualized goal setting and assessment and may superior for capturing meaningful and specific function and participation improvements. Framework analysis also underlined the lack of quantitative measurement of validation, compassion, self-awareness , self-efficacy , and resilience . While there is some overlap between these constructs and the factors of mindfulness addressed by the CAMS-R (i.e., self-awareness, acceptance), none of our instruments were validated to directly and completely assess them. These findings highlight constructs that have not been evaluated in previous studies of mindfulness-based interventions for PSaC, specifically resilience and validation, or outcomes that are rarely addressed, such as compassion, self-awareness, and self-efficacy [ 17 ]. Self-efficacy for example, is related to concussion symptom severity [ 78 ], but rarely measured in research on mindfulness-based interventions. Additionally, resilience has not been directly and quantitatively assessed in the studies on mindfulness-based interventions for TBI, yet it does occur in qualitative results [ 79 , 80 ], is recognized as a key element in symptom persistence [ 81 , 82 ]and optimizing recovery after TBI [ 17 ], and known to be a significant benefit of mindfulness-based interventions for the general population [ 83 , 84 ]. Our findings suggest that OWNMindfulness can support this meaningful outcome for individuals with PSaC. Taken as a whole, our mixed methods findings provide insights to guide measurement approaches, directing focus toward under investigated and clinically impactful outcomes. Furthermore, findings preliminarily suggest potential mechanisms of action for concussion recovery through mindfulness interventions, which is currently at the hypothesis stage [ 16 ]. There are several limitations to acknowledge. This was a single-arm pilot feasibility study with a small sample size. As such, we did not include a control group. Thus, we cannot be certain that the observed effects were due to the intervention and we lack the statistical power needed for a robust examination of the program’s effects. Relatedly, most of our participants were receiving other rehabilitation interventions concurrently to their participation in our study, thus their improvement could be attributed to other treatments. That said, we posit that our intervention may work best in the context of multidisciplinary care making it potentially important to include those actively receiving treatment, further many of the participants in this study were long post injury when natural recovery has slowed. Nevertheless, pilot studies of this sort are important for providing initial insights, identifying potential challenges, and informing more extensive investigations. Future studies with larger sample sizes should include comparison conditions to control for group support without mindfulness training, for therapeutic attention of any kind, and also natural recovery. Additionally, treatment was not masked, and the PI was the primary interventionist and qualitative interviewer. We implemented measures to control for bias in interviews, probing for differing viewpoints and unanticipated outcomes. We maintained a broad inclusion criteria in terms of time post onset, including individuals up to 5 years post injury, which is both a limitation and a strength. Those with very long times post onset may have other complicating concerns and diagnoses (e.g., depression) which can blur the distinction between persistent concussion symptoms and other co-occurring diagnoses. However, these individuals continue to seek care from their providers and concussion clinics, underscoring the clinical importance of assessing the feasibility and ultimately the efficacy of treatments for this chronic population. Notably, our sample was largely white and non-Hispanic/Latino women with advanced education. This pattern is consistent with the concerning trend of racial and ethnic disparities in TBI rehabilitation follow up [ 85 ] and mindfulness research [ 86 ]. Future research should include more participants with more gender, SES, and racial/ethnic diversity to adequately capture any differing experiences related to identity. We also aim to use the results of framework analysis to add additional measures targeting aspects of coping. CONCLUSION OWNMindfulness shows preliminary feasibility and promise for improving clinical outcomes among individuals with PSaC. Results of mixed-methods analysis inform more refined and sensitive measurement of effects and may point to mechanisms of action for such interventions. Future research should include efficacy trials with control conditions (e.g., group-based intervention with and without one-on-one sessions, group treatment without mindfulness training, and individual interventions) with larger and more diverse participant samples. Ultimately, this program of research holds promise to improve efficacy and boost accessibility of mindfulness-based treatments for people with PSaC. Supplementary Material Supp 1 NIHMS2032557-supplement-Supp_1.docx (38.7KB, docx) Implications for Rehabilitation. Integration of mindfulness-based interventions in standard rehabilitation care for persistent concussion symptoms has potential to boost recovery for this difficult to treat population. OWNMindfulness, a live-video mindfulness-based group intervention, can be delivered in a clinical education setting. People with persistent concussion symptoms may benefit from validation from providers and peers, self-compassion, self-awareness, and self-efficacy to support resilience and recovery. Acknowledgments: The authors thank Dr. Elise Townsend for contributions to the conceptualization of this project, and Dr. Franjo Ivankovic for statistical consultation. Funding Sources: JG’s contribution to this work was supported by the National Center for Complementary and Integrative Health [grant no #K23AT01065301A1]. Footnotes Conflicts of Interest: The authors report there are no competing interests to declare. Transparency Statements: The study and analysis plan were not formally registered in line with recommendations for feasibility studies. Data from this study, analytic code, and materials used to conduct the study are not publicly available. De-identified data and analytic code will be made available (as allowable according to institutional IRB standards) by emailing the corresponding author. 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