NCT05698914

Telehealth Mindfulness After Spine Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

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.

Conditions

• Lumbar Spine Surgery
• Chronic Low-back Pain
• Postsurgical Pain

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-02-22
• Primary completion: 2025-07-11
• Completion: 2025-07-11
• First posted: 2023-01-26
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States