Telehealth Mindfulness After Spine Surgery

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).

Conditions

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

Interventions

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.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Carrie E Brintz, PhD · Vanderbilt University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-22

Primary Completion

2025-07-11

Completion

2025-07-11

Countries

• United States

Study Locations