Telehealth Mindfulness After Spine Surgery

NCT05698914 | Completed DMC

• 2 other identifiers: 221711K23AT011569
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is it feasible and acceptable to deliver the interventions and conduct the study procedures in this patient population?
2. 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?
3. 3.Complete self-report questionnaires online before spine surgery, and around 2 weeks, 3 months, and 6 months after spine surgery.
4. 4.Complete a sensory pain task before spine surgery, and around 2 weeks, 3 months, and 6 months after spine surgery.
5. 5.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).

Conditions

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

Keywords

Mindfulness; Telehealth

Outcome Measures

Primary Outcomes (5)

• Enrollment Rate

  Proportion of participants approached who are eligible and enroll in the study

  Through enrollment completion, approximately 21 months

• Participant study retention

  Proportion of participants who complete the study (6 month assessment)

  Through study completion, approximately 28 months

• Session attendance

  Average percentage of sessions attended

  Through 3 months postoperative

• Intervention Satisfaction

  Proportion of participants reporting overall satisfaction levels greater than or equal to 7 out of 10

  3 months postoperative

• Home practice completion

  Average days practiced out of days assigned practice (MBI group only)

  Through 3 months postoperative

Secondary Outcomes (19)

• Pain Bothersomeness

  Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

• Pain Interference Short-form 8a

  Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

• Overall Pain Intensity Overall Pain Intensity

  Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

• Back and leg pain intensity

  Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

• Self-reported opioid medication use

  Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

Study Arms (2)

Telehealth mindfulness-based intervention (MBI)

EXPERIMENTAL

Eight, weekly telehealth mindfulness sessions delivered one-on-one with mindfulness instructor

Behavioral: Telehealth mindfulness-based intervention (MBI)

Telehealth Education (EDU)

ACTIVE COMPARATOR

Eight, weekly post-surgical educational sessions delivered one-on-one with physical therapist

Behavioral: Telehealth Education

Interventions

Telehealth Education BEHAVIORAL

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.

Telehealth Education (EDU)

Telehealth mindfulness-based intervention (MBI) BEHAVIORAL

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.

Telehealth mindfulness-based intervention (MBI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking adults
• Aged 18 years and older
• Scheduled for a laminectomy and/or fusion at Vanderbilt Spine Center
• Scheduled for their first lumbar spine surgery
• Radiographic evidence of a degenerative condition including but not limited to spinal stenosis, spondylosis with or without myelopathy, and spondylolisthesis
• Presence of back and/or lower extremity pain persisting for at least 3 months
• Access to stable internet.
• Able to participate in weekly, remote sessions with a study therapist for 8 weeks after surgery

You may not qualify if:

• Microsurgical technique as the primary procedure (i.e. isolated laminotomy or microdiscectomy)
• Having surgery for the primary indication of a spinal deformity
• Having surgery secondary to pseudarthrosis, trauma, infection, or tumor
• Diagnosis of Alzheimer's disease or another form of dementia
• Traumatic Brain Injury (greater than mild severity)
• History of bipolar disorder or dissociative disorder
• Active substance use disorder (in past month)
• Current Posttraumatic Stress Disorder (PTSD) symptoms (in past month)
• Active suicidal ideation with intent

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Carrie E Brintz, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are masked to the names and specific details of each intervention arm at time of enrollment, and remain masked to the name and details of the intervention arm to which they are not randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 26, 2023
• Study Start: February 22, 2023
• Primary Completion: July 11, 2025
• Study Completion: July 11, 2025
• Last Updated: February 5, 2026

Record last verified: 2025-09

Locations

US (1)