Postoperative Telehealth Mindfulness Intervention to Improve Pain-related Outcomes and Reduce Opioid Use After Lumbar Spine Surgery
Phase: NA
Conditions: Chronic Low-back Pain, Postsurgical Pain, Opioid Use, Lumbar Spine Surgery
Sponsor: Vanderbilt University Medical Center

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Postoperative Telehealth Mindfulness Intervention After Spine Surgery  
 
NCT04648683  
 
Study Protocol and Statistical Analysis Plan Version date: 11/22/2021 
 

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Title: Optimizing a Postoperative Telehealth Mindfulness Intervention to Improve Pain-related 
Outcomes and Reduce Opioid Use After Spine Surgery 
 
Protocol 
 
 
 
 
 
 

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Design Synopsis 
 
Title: Optimizing a Postoperative Telehealth Mindfulness Intervention to Improve Pain-related 
Outcomes and Reduce Opioid Use After Spine Surgery 
 
Principal Investigator:  Carrie E. Brintz, PhD 
 
Participating Center: Vanderbilt University Medical Center 
 
Sponsors: Osher Center for Integrative Medicine at Vanderbilt (7/1/20 - 6/30/21); NIH - National 
Center for Complementary and Integrative Health (8/5/21 - 7/31/26) 
 
Type of study: Two-arm intervention development and feasibility pilot trial 
 
Objective: The overall objectives of our preliminary, mixed-methods project are to optimize a 
mindfulness-based intervention (MBI) for patients recovering from lumbar spine surgery to improve 
pain-related outcomes and reduce post-surgical opioid use, and to evaluate its feasibility and 
acceptability. We will pilot an existing, group-based MBI for chronic pain patients1 that we have 
formatted for both one-on-one and group telehealth delivery to postsurgical patients, and utilize 
participant feedback to tailor the intervention to post-surgical orthopaedic patients. 
 
 
Specific Aim 1: To evaluate the feasibility and acceptability of the telehealth MBI. We will 
conduct a nonrandomized, sequential pilot test of the individual telehealth MBI (approximately 16 
completers) and of the group telehealth MBI (approximately 8 completers) with patients recovering 
from lumbar spine surgery. We anticipate enrolling up to 34 participants to have 24 complete the study, 
Feasibility and acceptability of the individual and group intervention will be evaluated as recruitment 
rates, session attendance, home practice assignment, study retention, and participant satisfaction.  
 
 
 
Hypothesis 1: a) Participants will be recruited at a rate of 50%; b) Participants will attend 
90% of sessions on average; c) Participants will complete 80% of home practice assigned; d) Study 
retention will be 90% at post-intervention; e) 80% of participants will report moderate to high 
satisfaction with the intervention. 
 
Specific Aim 2: To further tailor the telehealth MBI to post-surgical orthopaedic patients. Using 
structured qualitative interviews and a post-intervention satisfaction survey during the open-label pilot 
test, we will obtain participant feedback regarding the one-on-one telehealth format, intervention 
components, and relevance to post-surgical concerns. Qualitative interviews will be coded and analyzed 
to inform revisions to the intervention.   
 
 
 
Expected outcome: The intervention will be revised based on participant feedback.   
 
 
 
 
 

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Study design: Two-arm, nonrandomized mixed-methods behavioral intervention trial 
 
Study duration: 1 year (1-month start-up; 7 months accrual; 2 additional months for intervention 
completion and data collection; 2 months for data analysis and intervention adaptation) 
 
Sample size: Up to 34 eligible patients will be consented; Approximately 16 patients will complete the 
individual intervention; 8 patients will complete the group intervention (consented and completion 
sample size may vary depending on when data saturation from qualitative interviews is reached).  
 
Number of study sites: 1 
 
Inclusion criteria: 
1) English-speaking adults  
2) Between the ages of 18 and 90  
3) Scheduled for a laminectomy and/or fusion 
4) scheduled for their first lumbar spine surgery  
5) Radiographic evidence of a degenerative condition including but not limited to spinal stenosis, 
spondylosis with or without myelopathy, and spondylolisthesis 
6) Presence of back and/or lower extremity pain persisting for at least 3 months 
7) Access to stable internet.  
8) Able to participate in weekly, remote sessions with a study therapist for 8 weeks after surgery 
 
Exclusion criteria: 
1) Microsurgical technique as the primary procedure (i.e. isolated laminotomy or microdiscetomy) 
2) Having surgery for the primary indication of a spinal deformity 
3) Having surgery secondary to pseudarthrosis, trauma, infection, or tumor  
4) Current/history of a primary psychotic or major thought disorder or hospitalization for reasons related 
to psychosis 
5) Diagnosis of Alzheimer’s disease or another form of dementia 
6) Traumatic Brain Injury (greater than mild severity) 
7) History of bipolar disorder or dissociative disorder 
8) Schizophrenia or other psychotic disorder (e.g. brief psychotic disorder, delusional disorder) 
9) Active substance use disorder (in past month) 
10) Current Posttraumatic Stress Disorder (PTSD) symptoms (in past month) 
 
Outcome measures: 
 
Primary outcomes:  
Intervention feasibility and acceptability (enrollment, session attendance, homework completion, 
intervention retention, intervention satisfaction, semi-structured interview).  
 
Secondary Outcomes: 
1) PROMIS-29 – Pain Intensity and Pain Interference 

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2) Pain Bothersomeness (1 item) 
3) Oswestry Disability Index (ODI) 
4) Self-reported and EMR-collected opioid dosage 
5) PROMIS-29 – Depression scale 
6) PROMIS-29 – Anxiety scale 
7) Pain Self-efficacy questionnaire (PSEQ) 
8) Five-Facet Mindfulness Questionnaire-15 (FFMQ-15) 
9) Perceived Stress Scale – 4  
10) Pain Catastrophizing Scale 
11) Tampa Scale for Kinesiophobia - 13 
 
Statistical analysis: Primary outcomes: Descriptive statistics to summarize feasibility and acceptability 
outcomes with numbers and rates. Qualitative interview analysis of transcribed interviews using line by 
line analysis and identification of themes and textual examples. Quantitative and qualitative data results 
will be merged to identify aspects of the telehealth MBI that need to be adapted to optimize acceptability 
for post-surgical patients. Secondary outcomes: Within-group, within-subject changes from baseline to 
the follow-up post-intervention assessment in pain-related outcomes, opioid use, and psychosocial 
characteristics will be explored by examining change in scores and their respective standard errors with 
95% confidence intervals 
 
Safety monitoring: The PI and research coordinator will monitor the accumulated data as the trial 
progresses to ensure patient safety, evaluate recruitment, and assess overall data quality. 
 
 
 
 

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1. Primary Hypothesis and Principal Objective 
 
Lumbar spine pain is the leading cause of years lived with a disability2 and affects over 50 million 
individuals in the United States.3 As the population over age 60 grows, rates of spine surgeries 
performed to address degenerative spine conditions have increased markedly.4 Yet, more than 40% of 
patients experience poor pain, functional, or quality of life outcomes after surgery.5–7 Moreover, despite 
the limited efficacy and high risks associated with long-term prescription opioid use8,9, up to 50% of 
patients are prescribed opioids 12 months following lumbar spine surgery.5,10 Pre- and post-surgical 
psychosocial factors are robust determinants of long-term post-surgical outcomes7,11–13 and continued 
opioid use.14  
Psychosocially informed interventions are recommended after spine surgery but not standard practice.15 
Patients recovering from spine surgery identify a need for nonpharmacological strategies to decrease 
pain and emotional distress.16 Mindfulness-based interventions (MBIs) demonstrate efficacy for 
improving chronic pain outcomes17–20, reducing opioid use or desire17,18,21, and favorably impacting pain 
sensitivity and psychosocial risk factors for persistent pain and disability.22–28 To date, no studies have 
tested the usefulness of an MBI in patients following spine surgery to manage post-surgical pain and 
reduce long-term opioid use. The group-based, in-person delivery format renders the typical MBI highly 
impractical for post-surgical patients who live several hours away from the surgical centers of 
excellence. Prior work indicates that telehealth MBIs (via live, online video) are feasible in chronic pain 
populations29 and are a promising alternative.  
The overall objectives of our preliminary, mixed-methods project are to tailor an MBI for patients 
recovering from spine surgery and to evaluate its feasibility and acceptability. We will pilot an existing, 
group-based MBI for chronic pain patients1 that the principal investigator (PI) modified for both one-on-
one and group telehealth delivery for postsurgical patients, and utilize participant feedback to tailor the 
intervention to post-surgical orthopaedic patients. The purpose of the intervention is to improve pain-
related outcomes and reduce post-surgical opioid use, so outcome measures will be collected to evaluate 
feasibility of data-collection procedures and pre-post changes.  
 
 

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2. Background and Significance 
 
Lumbar spine surgery outcomes are poor for up to 40% of patients. Spine pain affects millions of 
individuals in the United States and results in poor quality of life, reduced mental and physical 
functioning, and billions of dollars in healthcare costs and lost productivity.30 Complete resolution of 
chronic spine pain is uncommon. Lumbar spine surgery is the most common elected surgery to treat 
degenerative spinal conditions when conservative treatments are unsuccessful.31 As the population of 
older adults grows, rates of lumbar spine surgery have increased markedly.4,32 However, up to 40% of 
patients experience continued or worsening pain and disability following surgery. Studies find that 
patients’ expectations for improvement after surgery exceed their experienced reductions in back pain 
and leg pain, and improvements in functioning.16,33,34  A substantial number of patients who experience 
a significant reduction in pain intensity after spine surgery nonetheless report continued pain 
interference and disability7, suggesting that multiple factors and not merely a reduction in pain intensity, 
contribute to improved functional outcomes.  
 
Prolonged prescription opioid use is common following spine surgery. Studies indicate that 59%14 to 
65%10 of patients taking opioids pre-operatively continue to receive opioids 12 months following spine 
surgery.  Furthermore, as many as 26% of patients who were opioid-free prior to spine surgery do not 
achieve opioid independence 12 months after surgery.14,35 These findings are concerning, given the 
numerous risks of prolonged opioid use, including tolerance, opioid-induced hyperalgesia (paradoxically 
increased pain sensitivity), misuse, abuse, and overdose8,9,36–38, all of which can complicate post-surgical 
recovery. Effective strategies are needed to help patients reduce unnecessary or prolonged opioid use 
following surgery. 
 
Psychosocial factors are key predictors of post-surgical outcomes and opioid use. It is widely 
recognized that pain is experienced through a complex interaction of physical/neural, cognitive, 
affective, behavioral, and social factors.39 Studies consistently indicate that both pre and post-surgical 
psychosocial factors are robust predictors of surgical outcomes. Pre- and early post-surgical 
psychological distress, particularly depression and anxiety, significantly predict worse pain intensity and 
disability, physical functioning, and quality of life, as well as prolonged opioid use at 6 to 12 months 
following lumbar spine surgery.12–14,40–44  Individual coping style and cognitive factors, such as passive 
avoidant coping, high fear avoidance beliefs, and pain catastrophizing are associated with worse spine 
surgery outcomes.7,13,43,45,46 Conversely, higher levels of self-efficacy and positive affect are protective 
and associated with more favorable outcomes after orthopaedic surgery.12,47,48  
Psychosocially informed interventions are recommended after surgery15, but are not standard 
practice, despite promising research.49–51 Patients indicate a need for nonpharmacologic strategies to 
cope with post-surgical pain and emotional distress and as alternatives to taking pain medication.16,33 
Randomized controlled trials demonstrate that biopsychosocial rehabilitation programs targeting 
cognitive and behavioral factors after lumbar spine surgery result in improved pain, mental and physical 
functioning, pain self-efficacy, fear of movement, and pain coping compared with exercise or education 
alone.49,51,52  The majority of trials draw from traditional cognitive behavioral therapy for chronic pain. 
Although effective at improving pain-related outcomes, not all patients achieve benefit from cognitive 
behavioral therapy. Alternative biopsychosocial approaches to postoperative rehabilitation and pain 
management are needed in order to provide more widely effective and personalized treatment. The 

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proposed research will address this gap by establishing the feasibility and acceptability of an optimized 
mindfulness-based intervention (MBI), delivered using a telehealth approach (to maximize 
accessibility), for improving pain-related outcomes and opioid use.  
 
MBIs have a well-established evidence base as efficacious interventions for reducing chronic pain 
symptoms. Well-controlled studies indicate that MBIs are efficacious for improving physical 
functioning and pain interference, and reducing commonly co-occurring symptoms such as depression 
and anxiety in chronic pain populations.19,20,53  Furthermore, in RCTs targeting individuals taking opioid 
medications for chronic pain, MBIs were effective at reducing opioid misuse, craving, and/or opioid 
use.18 MBIs are now recommended as first-line nonpharmacological treatment for chronic low back 
pain.54 The most extensively studied MBIs (e.g.  mindfulness-based stress reduction and mindfulness-
based cognitive therapy), demonstrate similar efficacy as traditional cognitive behavioral therapy for 
chronic low back pain19,22,53. However, pilot research with chronic low back pain patients suggests that 
different patient characteristics predict better response to one type of treatment over another55, lending 
support for research and dissemination of multiple psychosocial treatment options to which patients can 
be individually matched.  
Central to MBIs is systematic and intensive training in mindfulness meditation practices.56 
Mindfulness skills involve the self-regulation of attention to present-moment experience and the 
development of non-judgmental awareness of moment-by-moment experience, including thoughts, 
emotions, or sensations that arise, even if unpleasant or unwanted.57,58 Mindfulness meditation engages 
emotional, cognitive, and sensory networks in the brain that regulate pain59, with meditators showing 
heightened sensory processing coupled with attenuated cognitive and emotional evaluation of pain 
sensations.60 Patients with chronic low back pain who participated in an MBI reported reduced pain 
catastrophizing and increased pain acceptance and self-efficacy to manage pain.22 Studies in low back 
pain patients and healthy participants demonstrated that after mindfulness training, participants 
experienced lowered pain sensitivity to thermal or electrical stimuli.25,26 There are no prior studies that 
have tested an MBI early following spine surgery as a means to prevent or mitigate poor post-surgical 
outcomes.    
 
Barriers to accessing MBIs impact successful implementation after spine surgery. The standard 
MBIs are typically located at major medical centers and offered as in-person, group-based interventions 
with 8 weekly sessions lasting 2 to 2 ½ hours each. This format is highly impractical for post-surgical 
spine patients, many of whom live hours away from surgical centers. Furthermore, group-based MBIs 
are frequently offered only a few times per year, and thus may not be available to patients early after 
surgery, a time when patients have indicated a need for additional nonpharmacological intervention to 
help optimize recovery. Telehealth is increasingly used in healthcare systems to reach patients across 
long distances who would not otherwise access healthcare services or research opportunities, and thus is 
a promising platform for reaching post-surgical patients.61,62 The proposed study will leverage existing 
telehealth technology62 to study a telehealth MBI (delivered live via online video platform) in both one-
on-one and group formats and tailored specifically to address the needs of patients following spine 
surgery. The result will be a clinically significant advance in the care of the large population of patients 
undergoing spine surgery each year.  
 
INNOVATION 
The proposed study is innovative in its tailoring of an existing MBI specifically for use in the 
orthopaedic surgery population. MBIs have been used for the management of chronic pain1, but 

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patients may experience distinct concerns after orthopaedic surgery. For example, severe, acute post-
operative pain due to surgical tissue damage can occur concurrently with residual chronic pain, and at 
times lead to new chronic pain. 63,64 Patients report experiencing post-operative distress, fear and 
avoidance of movement, and unmet expectations.13,16,33,34,64 In addition, patients may desire to taper off 
of pain medications as quickly as possible after surgery.33 Data from this study will help optimize an 
MBI for patients undergoing spine surgery, with application to other orthopaedic surgery populations. 
The proposed study is also innovative in its use of telehealth technology, which enables broad reach 
of the intervention to patients regardless of distance or transportation access and costs. Additional 
flexibility and opportunity to individually tailor the intervention is offered by the one-on-one, rather than 
group-based format. Telehealth delivery allows for the integration of a biopsychosocial approach into 
routine post-surgical spine care, as is recommended, without introducing substantial burden on patients. 
Other preliminary work by the principal investigator suggests that providing an MBI over telehealth is 
feasible in a chronic pain population29, but has yet to be investigated in post-surgical spine patients. 
Finally, the project is innovative in its integrated use of both quantitative and qualitative methods 
to produce an optimized MBI that is both feasible and acceptable in this population. 
 
 

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3. Study Design 
 
3.1. Design Overview. The study will use a two-arm, nonrandomized mixed-methods design to: 1) 
evaluate the feasibility and acceptability of a one-on-one telehealth MBI delivered via live, online video 
in approximately 24 patients following elective lumbar spine surgery for degenerative spine conditions, 
and 2) adapt the telehealth MBI to the specific concerns of post-surgical patients using both qualitative 
and quantitative data from post-intervention surveys and semi-structured interviews. Participants will be 
enrolled in either the individual intervention or the group intervention, and enrollment for each 
intervention will occur sequentially. Patient-reported outcomes (pain-related and psychosocial variables) 
and self-reported and electronically verified opioid use will be collected at pre-surgery, 2-weeks post-
surgery (pre-intervention), and 3 months post-surgery (post-intervention). Semi-structured interviews 
will be conducted at post-intervention 
 
Figure 1. Study Design 
 
 
3.2 Telehealth Mindfulness Intervention. The telehealth MBI consists of 8, weekly sessions with a 
study interventionist. The one-on-one intervention sessions will each be 75 minutes long, with the 
exception of the first session, which will be 90 minutes long. The group interventions sessions will each 
be 90 minutes long. Participants will be asked to complete the 8 sessions within 10 weeks to allow for 
missed weeks. All sessions will be conducted using an IRB-approved HIPAA compliant telehealth 
platform in which the intervention is delivered via secure internet video link and audio-recorded for 
fidelity monitoring. The intervention is based on an existing manualized MBI (mindfulness-based 
cognitive therapy for chronic pain).1 Mindfulness-based cognitive therapy was originally developed for 
preventing relapse of depression65 and has since been adapted and tested in chronic pain populations, 
including chronic low back pain and headache pain.24,53 The intervention, typically delivered in-person 
in a group setting, will be formatted for both one-on-one and group telehealth delivery, with subsequent 
data-driven adaptation planned.  Participants who do not have their own device with microphone and 
video camera (e.g. computer, tablet, or smart phone) will be given a tablet to use during the study. 
  
At the core of the telehealth MBI is systematic instruction and practice in mindfulness 
meditation, which trains the self-regulation of attention to present moment experience and fosters a 
nonjudgmental and accepting response to one’s experience, including pain sensations.53 Participants 
learn meditation practices that can be completed sitting or lying down as well as gentle mindful 
movement practices that can be completed while walking, standing, or sitting. Education on the brain-
pain relationship (gate-control and neuromatrix theory) is also provided and mindfulness skills are 
discussed within the context of pain management. Because of the importance of cognition and emotion 
in pain processing, the intervention incorporates elements of cognitive therapy including exercises in 
recognizing the connection between thoughts, emotions, behaviors, and stress as they relate to chronic 
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interference and distress, and to process and respond to unpleasant sensations and emotions more 
skillfully. Each session focuses on didactic information (introduced interactively), practicing a new 
mindfulness skill with discussion, reviewing previous skills, and assigning home practices. Participants 
will be requested to keep track of their practicing by completing a Home Record Practice. The 
participants will be giving a paper copy and then asked to complete in a Survey electronically each 
week. 
Interventionist Training and Fidelity Monitoring. The PI will oversee intervention training and delivery 
with Dr. Foote-Pearce (co-investigator). Our study interventionist will be a doctoral trained clinical 
psychologist who has completed prior training in mindfulness skills facilitation and cognitive therapy 
through graduate-level work and/or formal training workshop(s). The PI will provide structured training 
in the study intervention manual with a 1-day workshop covering intervention content. This workshop 
will cover each session module, with role-playing interactions. There will be weekly supervision of the 
study interventionist by the PI, through the review and discussion of audio-recorded sessions and fidelity 
checklists. All sessions of the first 2 patients will be monitored and reviewed and then 25% of the 
sessions will be randomly selected for review during weekly sessions. The interventionist will complete 
a checklist of all the components delivered during each session and make note of any protocol 
deviations.  
Potential adverse effects: Based on results of previous literature, we expect there to be no more than 
minimal risk in this study; however, literature on mindfulness-based interventions have not 
systematically included adverse event reporting, although most studies have not reported any serious 
risk from participating. There have been reports of increased emotional distress and increased awareness 
of both positive and negative experiences, which may initially increase distress when participants are not 
used to directing attention towards unpleasant thoughts, feelings, and sensations.66 There is the potential 
for increased negative emotions at the beginning of the course, as well as the possibility that history of 
trauma, abuse, or substance addiction could heighten negative emotional reactions. With a trained 
interventionist, reactions can be managed and appropriate referrals made.66 There also the possibility of 
emotional distress related to completing questionnaires about mood and pain-beliefs. 
 
4. Patient Selection.  
 
4.1. Overview and Clinical Centers. Approximately 34 patients scheduled to undergo lumbar spine 
surgery will be recruited from Vanderbilt University Medical Center. The Vanderbilt Comprehensive 
Spine center treats large numbers of lumbar degenerative conditions and has a proven track record for 
prospective study of patients having lumbar spine surgery. Eligible patients will be identified and 
recruited at the participating clinical center subject to the inclusion and exclusion criteria listed below.   
 
Inclusion criteria: 
1) English-speaking adults  
2) Between the ages of 18 and 90  
3) Scheduled for a laminectomy and/or fusion 
4) scheduled for their first lumbar spine surgery  

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5) Radiographic evidence of a degenerative condition including but not limited to spinal stenosis, 
spondylosis with or without myelopathy, and spondylolisthesis 
6) Presence of back and/or lower extremity pain persisting for at least 3 months 
7) Access to stable internet.  
8) Able to participate in weekly, remote sessions with a study therapist for 8 weeks after surgery 
 
Exclusion criteria: 
1) Microsurgical technique as the primary procedure (i.e. isolated laminotomy or microdiscetomy) 
2) Having surgery for the primary indication of a spinal deformity 
3) Having surgery secondary to pseudarthrosis, trauma, infection, or tumor  
4) Current/history of a primary psychotic or major thought disorder or hospitalization for reasons related 
to psychosis 
5) Diagnosis of Alzheimer’s disease or another form of dementia 
6) Traumatic Brain Injury (greater than mild severity) 
7) History of bipolar disorder or dissociative disorder 
8) Schizophrenia or other psychotic disorder (e.g. brief psychotic disorder, delusional disorder) 
9) Active substance use disorder (in past month) 
10) Current Posttraumatic Stress Disorder (PTSD) symptoms (in past month) 
 
5. Trial Protocol 
 
5.1. Overview.  The patient-related activities of the postoperative telehealth mindfulness trial can be 
divided into the following phases. 
 
Phase 1: Consent into study and screening for eligibility 
Phase 2: Enrollment into trial prior to surgery, preoperative data collection  
Phase 3: Postoperative Baseline data collection (2 weeks after surgery)  
Phase 4: Intervention (8 weeks) 
Phase 5: Post-intervention data collection and semi-structured interviews (3 months after surgery)  
 
5.2. Phase 1: Consent into Study and Screening for Eligibility. Patients will be approached for their 
consent to participate in the study following their preoperative clinic visit either at the clinic as available 
or over the phone, with the permission of the treating surgeon. If over the phone, participants will sign 
an e-consent form through a REDCap survey link. The study coordinator will perform the consent 
process using a scripted dialogue and materials developed for the study. 
 
Patients will then be screened for eligibility in the surgical center or over the phone by the research 
coordinator. Screening through the medical record will occur prior to surgery and a scheduled 
preoperative clinic visit. Additional screening will occur either immediately after the preoperative clinic 
visit at the Spine Center or after the visit over the phone by the study coordinator through a list of 
screening questions. All potentially eligible patients will be entered into REDCap, a study number 
assigned, and eligibility criteria confirmed.  
 

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5.3. Phase 2: Enrollment and Preoperative Data Collection. Once consented into the study and 
determined to be eligible, patients will complete a preoperative questionnaire using a REDCap survey 
either at the clinic after the visit, online after the visit, or over the phone after the visit if preferred. This 
self-report assessment will gather data on patient demographic and injury characteristics, medical and 
social history, pain self-efficacy, negative affect, dispositional mindfulness, concerns about pain, current 
opioid use and preoperative levels of pain and disability. Opioid prescription and dosages will also be 
extracted from the electronic medical record.  
 
5.4. Phase 3: Baseline Data Collection (2 weeks after surgery). Study participants who complete 
surgery will be emailed or texted (based on participant preference) a REDCap survey to collect baseline 
data at two-weeks after surgery. They can also complete the survey at the postoperative clinic visit or 
over the phone. Similar to the pre-operative questionnaire, this self-report assessment will gather data on 
pain self-efficacy, negative affect, dispositional mindfulness, concerns about pain, current opioid use 
and levels of pain and disability. Opioid prescription and dosages will also be extracted from the 
electronic medical record.  
 
At this time, participants will also meet with the research coordinator, either at their post-operative clinic 
visit or by phone, to become oriented to the telehealth platform that will be used during intervention 
sessions. If the participant does not have their own device for use during the intervention, they will be 
provided with a tablet by the research coordinator.  
 
5.5 Phase 4: Treatment. Once the patient has been consented, undergone surgery for a lumbar 
degenerative condition, and completed the baseline assessment, the participant will begin the telehealth 
mindfulness intervention. The interventionist will call the participant to schedule the first treatment 
session. For participants enrolled in a group, the coordinator will gather participants’ availability and 
schedule the group sessions at a time when the interventionist and as many participants as possible are 
available. Patients will complete 8, weekly sessions over telehealth (audio and video), and will have 10 
weeks to complete the intervention to allow for 1 to 2 possible missed weeks. Participants will be asked 
to complete a paper form asking about their daily practice of what they have learned and then enter that 
information weekly into the Home Practice Record Survey electronically. 
 
5.6. Phase 5: Post-Treatment Data Collection (3-months after surgery). After completing the 
intervention (3 months after surgery), participants will be emailed or texted a REDCap survey. They can 
also complete the survey at the postoperative clinic visit or over the phone. Similar to the pre-operative 
and post-operative baseline questionnaire, this self-report assessment will gather data on pain self-
efficacy, negative affect, dispositional mindfulness, pain sensitivity, current opioid use and levels of 
pain and disability. It will also gather data on participant satisfaction with the telehealth mindfulness 
intervention. Opioid prescription and dosages will also be extracted from the electronic medical record.  
 
The research coordinator will assist patients with scheduling a post-treatment qualitative phone 
interview, which will be conducted by a study investigator with qualitative research experience. Each 
phone interview will last approximately 30 minutes and be audio-recorded. The semi-structured 
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experiences and perceptions of the telehealth delivery format, intervention components (mindfulness 
skills, didactics, home practice), perceived benefits, relevance to post-surgical concerns, concerns not 
addressed by the intervention, barriers to participation, and suggestions to improve the intervention. The 
interview guide is designed to revised as needed throughout the study (e.g. changes in wording of 
questions and probes to be more clear; addition of questions that seem pertinent based on prior 
participants’ responses to interview questions). 
 
5.7. Primary and Secondary Outcomes 
 
Primary outcomes:  
Intervention feasibility and acceptability (enrollment, session attendance, homework completion, 
intervention retention, intervention satisfaction, semi-structured interview).  
 
Secondary Outcomes: 
1) PROMIS-29 – Pain Intensity and Pain Interference 
2) Pain Bothersomeness (1 item) 
3) Oswestry Disability Index (ODI) 
4) Self-reported and EMR-collected opioid dosage 
5) PROMIS-29 – Depression scale 
6) PROMIS-29 – Anxiety scale 
7) Pain Self-efficacy questionnaire (PSEQ) 
8) Five-Facet Mindfulness Questionnaire-15 (FFMQ-15) 
9) Perceived Stress Scale – 4  
10) Pain Catastrophizing Scale (PCS) 
11) Tampa Scale for Kinesiophobia - 13 
 
 
5.8 Safety Issues.  
 
5.8.1. Safety Concerns Related to the Therapeutic Treatment. We anticipate based on previous 
research of mindfulness training interventions that the study will pose minimal safety risk; most studies 
have not reported any serious risk from participating in structured MBIs. There have been reports of 
increased emotional distress and increased awareness of both positive and negative experiences, which 
may initially increase distress when participants are not used to directing attention towards unpleasant 
thoughts, feelings, and sensations.66 With a trained instructor, reactions can be managed. It is possible 
that history of trauma or substance addiction could heighten negative emotional reactions. Participants 
with unstable psychiatric illness or substance addiction will be excluded from participation.66 There may 
also be distress related to answering questionnaires about mood and pain beliefs. 
 
5.8.2. Safety Issues Related to Patient Privacy. Patients will only be identified by an identification 
code and not by their name, SSN, or hospital medical record number. Study personnel will maintain a 
separate confidential enrollment log which matches identifying codes with the patients’ names and 
addresses (available only to study personnel). Enrollment logs will be kept in a secured, password-
protected file on a VUMC-approved server. All study material will be maintained in strict confidence. 

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For participants enrolled in the group intervention, there is a risk to loss of confidentiality by nature of 
being in a group with other patients. All participants will be asked to agree to keep other participants’ 
information confidential within the group setting. 
 
5.9 Retention.  The study participants will receive an honorarium in recognition of their time and effort. 
Participants will be compensated $20 each for completing the preop intake assessment survey, the 2-
week postop baseline assessment survey, and the 3-month postop assessment and intervention 
assessment survey (up to $60) and $25 for completing the semi-structured phone interview, for a 
possible total of $85 per participant. Participants will not be compensated for completing the weekly 
Home Practice Record Survey. We will keep participants engaged through reminder emails and phone 
calls for intervention sessions and assessments.  
 
5.10. Management of Concomitant Conditions.  Concomitant conditions will be managed with the 
standards of care at the local treatment facility and should not be affected by study participation. 
 
5.11. Adverse Event Reporting.  We will monitor and report adverse events to ensure patient safety.  
 
5.11.1. Definitions. We will use the following definitions in identifying adverse events.  
 
• Adverse event. An adverse event is any untoward medical occurrence that may present itself during 
treatment or administration with clinical procedure and which may or may not have a causal 
relationship with the treatment. Adverse events include any unanticipated problems involving risks 
to participants, or breaches of protocol which might entail risk to participants. The term 
"unanticipated problem" includes both new risks and increased rates of anticipated problems. 
 
• Serious adverse event. A serious adverse event (SAE) is an adverse event occurring at any time 
during the study that results in death, inpatient hospitalization or prolongation of existing 
hospitalization, or a persistent or significant disability/incapacity. Other events may also be 
considered an SAE if, based on medical judgment, the event jeopardized the patient to the point of 
requiring medical or surgical intervention to prevent the occurrence of any of the conditions for an 
SAE listed above. 
 
• Unexpected adverse event. An unexpected adverse event is any adverse event with specificity or 
severity that is not consistent with the risk information in the study protocol. 
 
• Associated with the use of the treatment means that there is a reasonable possibility that the 
adverse experience may have been caused by the treatment. 
 
5.11.2. Monitoring and Reporting Adverse Events. Adverse events will be recorded on study data 
forms whether or not they are thought to be associated with the study or with one of the study 
treatments. Adverse events may be discovered during regularly scheduled visits or through unscheduled 
patient contacts between visits. IRB requirements for reporting adverse events will be followed. Where 
applicable, signs and symptoms associated with the adverse event will be graded as to severity by the 
clinical study staff as mild, moderate, or severe using the Common Terminology Criteria for Adverse 
Events. 

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5.11.3. Reporting Serious Adverse Events. Serious adverse events (SAE) must be reported upon 
discovery. This will involve completing an SAE case report form describing the severity and details of 
the event. IRB requirements for reporting SAEs will be followed.  
 
6. Statistical Analyses.  
 
6.1. Statistical Analysis Plan. Descriptive statistics will be used to summarize quantitative feasibility 
outcomes with numbers and rates. Benchmarks for success of the telehealth MBI will be: 1) enrollment 
rate of at least 50% of eligible patients; 2) 90% of sessions attended on average; 3) 80% of home 
practice completed on average; 4) intervention retention of at least 90%; 5) moderate to high 
intervention satisfaction rated by at least 80% of participants.  
 
Transcription of interview data will be verified prior to analysis. The PI and study personnel will 
conduct line by line analysis using Dedoose analytic software. Themes and textual examples will be 
independently identified and subsequently discussed for consensus. Analysis will be an ongoing, 
iterative process following each 2 to 4 interviews to ensure that data saturation ultimately occurs before 
discontinuing interviews A codebook will be generated by isolating individual quotes and refined as 
additional interviews are coded. Thematic analysis of codes will be used to identify emergent themes, or 
patterns of meaning, found in the data67 with regards to participant experiences with the telehealth MBI 
and specific post-surgical concerns. Quantitative and qualitative data results will be merged to identify 
aspects of the telehealth MBI that need to be adapted to optimize acceptability for post-surgical patients.  
 
Within-group, within-subject changes from baseline to the follow-up post-intervention assessment in 
pain-related outcomes, opioid use, and psychosocial characteristics will be explored by examining 
change in scores and their respective standard errors with 95% confidence intervals.         
 
7. Human Subjects Issues  
 
7.1. Sources of Materials.  All materials will be collected and recorded for research purposes. The 
socio-demographic, clinical, and outcomes information collected during this investigation will be 
obtained from multiple sources, including subjects directly, medical records, and hospital databases. 
These data will be entered directly into REDCap (a secure, web-based application. All data will be 
secured by password-only access for the purpose of confidentiality. The surgery and clinic notes will 
also be used to collect data. Outcomes data will be derived from questionnaires completed both in the 
clinic and online remotely, and through interactions between the patient and research personnel during 
semi-structured phone interviews.  
 
7.2. Potential Risks.  The risk to human subjects of participation in this study is minimal due to the 
nature of this behavioral treatment. The possibility exists that a participant may experience a degree of 
emotional discomfort related to intervention activities resulting in increased awareness of unpleasant 
experiences, or emotional distress due to completing questionnaires about mood and pain-beliefs. 
Research personnel and study interventionists will have referral sources available for individuals who 
request or are in need of further counseling or support. Study interventionists will be post-doctoral level 
psychologists with training in responding to potential increase in distress during the study, as well as 

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responding to reports of severe depression, suicidal ideation, or other medical/psychological problem 
requiring additional attention. If this should occur, the PI and referring surgeon will be notified and 
appropriate referrals arranged. There is a small risk of breach of confidentiality, but the data for this 
study will be secured in a password protected database. Access to this database will be limited to the 
investigators and study staff. Data will be deidentified for data analysis and interpretation. 
 
7.3. Recruitment and Informed Consent.  Prototype consent will be prepared for the trial. Before 
approaching patients for enrollment prior to surgery, discussions will be conducted with patients’ 
surgeons to obtain permission. The surgeon and clinical staff will be fully informed of the nature of the 
study and any risks and benefits. The research coordinator will approach the patient after the 
preoperative clinic visit or a preoperative education class. The coordinator will meet with the patient, as 
well as family members if requested by patient, and will describe the proposed study protocol using a 
scripted dialogue and materials developed for the study. It will be emphasized to all study participants 
and family members that the data collected will be for research purposes and that refusal to participate in 
the investigation will have no effect on the patient’s routine treatment. The person obtaining consent will 
inform the patient that there is no obligation to participate in the study, and will provide his/her name 
and phone number where he/she can be reached if they have further questions or wish to withdraw from 
the study at any time. The person obtaining the consent will also provide the patient with a copy of the 
consent forms and provide ample time for the patient and family to have questions answered prior to 
enrollment. Copies of the signed consent forms will be given to the patient, and this fact will be 
documented in the patient’s record. 
 
7.4. Protections Against Risk.  Under the auspices of the Vanderbilt Institutional Review Board, all 
participants will be protected by the project’s staff strict adherence to study protocols governing 
participant safety, data privacy, informed consent, withdrawal from the study without prejudice, and 
immediate reporting directly to the PI and the IRB of any adverse events involving the participants. Data 
obtained with subject identifiers will be kept in password protected electronic files on a VUMC server. 
All subjects will be assigned a unique study number for use in the REDcap database and all electronic 
data will be kept in password-protected files to ensure confidentiality. Participants will continue to have 
access to their usual sources of medical care throughout the study. These measures will provide a very 
high level of protection against risk to the participants.   
 
7.5. Potential Benefits of the Proposed Research to Human Subjects and Others.  All participants 
will gain additional assistance through the one-on-one or group telehealth mindfulness intervention in 
managing their pain and disability and we anticipate that patients in the study will report improvements 
in pain interference, function, and psychological well-being. There may also be a potential benefit 
derived from being enrolled in an investigation and having additional patient assessments. Such 
additional assessments may detect unrecognized clinical and health issues, which could be of benefit to 
patients’ outcomes. Finally, participants may derive a great deal of personal comfort in knowing that 
their psychological distress are part of the surgical recovery process. Thus, a potential benefit may be a 
reduction in stress and anxiety over recovery. The potential for direct patient benefit outweighs any 
minimal risk of harm to the participants.  
 
7.6. Importance of the Knowledge to be Gained.  The proposed study is intended to provide new 
knowledge about the feasibility, acceptability, potential effects, and optimal approach to providing a 
behavioral intervention to a post-surgical population. Such knowledge is important because the 

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population of surgical spine patients is growing rapidly, the current treatment regimen appears 
insufficient based on outcome variability, and there are few other promising therapeutics alternatives for 
dealing with postoperative recovery.  
 
7.7. Patient Confidentiality.  All study forms, reports, and other records that are part of the study data 
collection materials will be identified by coded number to maintain patient confidentiality. All electronic 
records of study data will be identified by coded number. Clinical information will not be released 
without written permission of the patient, except as necessary for monitoring by the IRB. Consent 
procedures and forms, and the communication, transmission and storage of patient data will comply with 
IRB requirements for compliance with The Health Insurance Portability and Accountability Act 
(HIPPA). 
 
 

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