Telehealth Mindfulness After Spine Surgery

Postoperative Telehealth Mindfulness Intervention After Lumbar Spine Surgery: Pilot Randomized Controlled Trial

The goal of this pilot clinical trial is to compare two behavioral interventions for patients who are recovering from lumbar spinal surgery for a degenerative spine condition. The study aims to answer the following questions:

1. Is it feasible and acceptable to deliver the interventions and conduct the study procedures in this patient population?
2. Do the interventions benefit patients with regard to pain-related, functional, opioid use, and psychosocial outcomes at 3 and 6 months after surgery, and does one intervention have more benefit than the other?

Participants will be asked to do the following:

1. Complete self-report questionnaires online before spine surgery, and around 2 weeks, 3 months, and 6 months after spine surgery.
2. Complete a sensory pain task before spine surgery, and around 2 weeks, 3 months, and 6 months after spine surgery.
3. Around two weeks after surgery, participants will be randomly assigned by chance to one of two behavioral interventions - Mindfulness or Education. Participants will then be asked to attend 8, weekly sessions with a study treatment coach over telehealth (online with camera and microphone).

Study Overview

• Status: Completed
• Conditions: Chronic Low-back Pain; Postsurgical Pain; Lumbar Spine Surgery
• Intervention / Treatment: Behavioral: Telehealth mindfulness-based intervention (MBI); Behavioral: Telehealth Education

Detailed Description

This is a pilot randomized clinical trial comparing a telehealth mindfulness-based intervention (MBI) with a telehealth education intervention (EDU) for patients recovering from spine surgery. The procedures will be as follows:

1. Enroll patients prior to lumbar spine surgery for a degenerative spine condition at the Vanderbilt Comprehensive Spine Center. Recruitment, enrollment, and screening will occur at a routine preoperative clinic visit or over the phone.
2. Two weeks after enrolled participants complete surgery, they will be randomized in a 3:2 ratio to either MBI or EDU condition, respectively. Randomization will be stratified by chronic preoperative opioid use (yes/no). The randomization assignments will remain concealed from all study personnel until the time of randomization. The outcome assessor and surgical providers will remain blinded to participant study condition.
3. Within four weeks of surgery, participants will begin the assigned intervention. The interventions will consist of meeting with an interventionist for eight, weekly one-on-one telehealth MBI sessions over an online telehealth platform. MBI sessions will led by a clinical psychologist and will be 75 minutes long (90 minutes for the first session). EDU sessions will be led by a physical therapist and will be 30 minutes long. Sessions will be audio recorded and monitored for fidelity.

3) Participants will complete self-report assessments online prior to surgery, two weeks after surgery (pre-intervention), three months after surgery (post-intervention) and 6 months after surgery.

4) Participants will complete quantitative sensory testing assessments of pain tolerance, pain threshold, and temporal summation of pain prior to surgery, two weeks after surgery, three months after surgery, and 6 months after surgery.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. English-speaking adults
2. Aged 18 years and older
3. Scheduled for a laminectomy and/or fusion at Vanderbilt Spine Center
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 microdiscectomy)
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 (e.g. Schizophrenia, brief psychotic disorder, delusional disorder). Medication-induced psychosis is not exclusionary.
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. Active substance use disorder (in past month)
9. Current Posttraumatic Stress Disorder (PTSD) symptoms (in past month)
10. Active suicidal ideation with intent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telehealth mindfulness-based intervention (MBI); Eight, weekly telehealth mindfulness sessions delivered one-on-one with mindfulness instructor	Behavioral: Telehealth mindfulness-based intervention (MBI); The telehealth MBI is adapted from Mindfulness-based cognitive therapy for chronic pain and consists of eight, weekly 75-minute individual sessions (90 minutes allotted for the first session) with a mindfulness interventionist delivering the intervention over telehealth (online with audio and video camera) in addition to the patient receiving their usual postsurgical care. Participants will begin the intervention after completing the 2-week postoperative assessment and within 4 weeks after surgery. Participants will be asked to practice skills between sessions approximately 20-40 minutes per day.
Active Comparator: Telehealth Education (EDU); Eight, weekly post-surgical educational sessions delivered one-on-one with physical therapist	Behavioral: Telehealth Education; Participants will receive a written educational booklet at the time of randomization (within 2-4 weeks after surgery) and 8, weekly telehealth sessions lasting 30 minutes in addition to usual postsurgical care. The educational materials are reviewed individually with the participant during weekly telehealth sessions (online with audio and video camera) by a physical therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Satisfaction	Proportion of participants reporting overall satisfaction levels greater than or equal to 7 out of 10	3 months postoperative
Enrollment Rate	Proportion of participants approached who are eligible and enroll in the study	Preoperatively, from when the potential participant is approached for recruitment until the time at which a potential participant is either eligible and consents to enroll in the study, or is ineligible or declines to enroll in the study, up to 2 weeks.
Participant Study Retention	Proportion of participants who complete the study (6 month assessment)	6 months postoperative
Session Attendance	Average proportion of sessions attended out of 8 sessions	Through 3 months postoperative
Home Practice Completion	Average days practiced out of days assigned practice (MBI group only)	Through 3 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Bothersomeness	One item assessing how bothersome pain has been in the past 7 days from 0 = not at all to 4 = extremely. A lower scores indicates lower pain bothersomeness.	Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Pain Interference Short-form 8a	Pain Interference short-form 8a from the Patient Reported Outcomes Measurement Information System scale. Measures interference of pain over the past 7 days. Consists of 8 items with response options from 1 = not at all to 5 = very much. The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. A lower score indicates lower pain interference, or a better outcome.	Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Back Pain Intensity	1 item assessing back pain intensity on a scale of 0-10 over the past 7 days, described as pain when off medication or medication has worn off. Lower scores indicate less pain, or better outcome.	Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Leg Pain Intensity	1 item assessing leg pain intensity on a scale of 0-10 over the past 7 days, described as pain when off medication or medication has worn off. Lower scores indicate less pain, or better outcome.	Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Anxiety Short Form 4a	Anxiety short-form 4a - Patient Reported Outcomes Measurement Information System. 4 items assessing anxiety symptoms in the past 7 days (e.g. "I felt fearful") with response options from 1 = never to 5 = always. The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. Lower scores represent lower anxiety, a better outcome	Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Physical Function	Physical Function short-form 4a - Patient Reported Outcomes Measurement Information System. 4 items assessing physical function in the past 7 days (e.g. "Are you able to do chores such as vacuuming or yard work?") with response options from 1 = Unable to do to 5 = Without any difficulty. The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. Higher scores represent better physical function, a better outcome	Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Depression Short Form 4a	Depression short-form 4a - Patient Reported Outcomes Measurement Information System scale. 4 items assessing depressive symptoms over the past 7 days (e.g. "I felt worthless) with response options from 1 = never to 5 = always. The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. A lower score indicates less depression, a better outcome.	Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Sleep Disturbance Short Form 4a	Sleep disturbance short-form 4a - Patient Reported Outcomes Measurement Information System scale. 4 items assessing sleep disturbance over the past 7 days (e.g. "I had difficulty falling asleep) with response options from 1 = not at all to 5 = very much (1 item reverse-scored). The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. A lower score indicates less sleep disturbance, a better outcome.	Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Oswestry Disability Index	Assesses impact of pain on level of functioning in 10 areas (e.g. walking, sleep, social life) with 10 items with response options with scores 0 to 5. Total scores are calculated as a percentage, ranging from 0% to 100%. Lower scores indicate a lower level of disability due to pain, a better outcome.	Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Pain Catastrophizing Scale	13 items assessing thoughts and feelings when in pain (e.g. "I become afraid that the pain will get worse" with response options ranging from 0 = never to 4 = all the time. Total scores range from 0 to 52 units on the scale. Lower scores indicate lower pain catastrophizing, a better outcome.	Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Pain Self-efficacy Questionnaire	10 items assessing confidence in ability to do certain things despite pain (e.g. "I can enjoy things, despite the pain" with response options 0 = not at all to 6 = completely. Total scores range from 0 to 60 units on the scale. Higher scores indicate greater pain self-efficacy, a better outcome.	Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Perceived Stress Scale - 4	4 items assessing perceived level of stress in the past month (e.g. "In the last month, how often have you felt that you were unable to control the important things in your life?"), with response options ranging from 0 = never to 4 = very often (2 items reverse-scored). Total scores range from 0 to 16 units on the scale. Lower scores indicate lower perceived stress, a better outcome.	Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Tampa Scale for Kinesiophobia -13	13 items assessing fear of movement (e.g. "I'm afraid that I might injure myself if I exercise" with response options ranging from 1 = strongly disagree to 4 = strongly agree. Total scores range from 13 to 52 units on the scale. Lower scores indicate lower levels of kinesiophobia, a better outcome.	Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Five Facet Mindfulness Questionnaire - 15	15 items assessing 5 facets of mindfulness, including observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Response options range from 1 = never to 5 = always (7 items reverse scored). Total scores are an average of the sum of all items, ranging from 1 to 5 units on the scale. Higher scores indicate higher levels of mindfulness, a better outcome.	Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Number of Participants Indicating They Currently Use Opioids	Participants were asked in one item "Are you currently taking an opioid medication?" Response options included "Yes" or "No." A response of Yes counted as 1 and No counted as 0 when calculating total frequency of participants reporting current opioid use.	Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Pain Tolerance	The duration of time participants tolerated an inflated blood pressure cuff: Using an ischemic task involving squeezing a dynamometer followed by inflated blood pressure cuff on arm, the time in seconds at which the participant indicated they could no longer tolerate the stimulus (inflated blood pressure cuff). Scores could range from 0 seconds to 300 seconds, as the task was discontinued at 300 seconds if reached prior to the participant indicating to stop the task.	Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Pain Threshold	Duration at which participants indicate a stimulus is experienced as painful: Using an ischemic task involving squeezing a dynamometer followed by inflated blood pressure cuff on arm, the point in seconds at which the stimulus (inflated blood pressure cuff) is first reported by the participant as painful. Scores could range from 0 seconds to 300 seconds, as the task was discontinued at 300 seconds if participants did not yet indicate that the stimulus was painful.	Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Temporal Summation of Pain	Using a punctate stimuli (von frey hairs of 100g and 180g of force to the finger), the difference between reported pain intensity during a single prick and the reported highest pain intensity during repeated brief pricks at a constant intensity. Pain intensity was measured on a scale of 0 to 100. The difference score was calculated by subtracting the pain intensity with single prick from the pain intensity with repeated pricks and could range from 0 to 100 units of difference on the pain intensity scale. Lower values are a more favorable outcome.	Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Carrie E Brintz, PhD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Actual): July 11, 2025
• Study Completion (Actual): July 11, 2025

Study Registration Dates

• First Submitted: December 27, 2022
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): August 13, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Mindfulness; Telehealth
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: 221711; K23AT011569 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No