Postoperative Telehealth Mindfulness Intervention After Spine Surgery
Condition: Chronic Low-back Pain; Postsurgical Pain; Opioid Use; Lumbar Spine Surgery
MeSH terms: Low Back Pain; Pain, Postoperative
Study type: Interventional

Summary: 
      Lumbar spine pain is the leading cause of years lived with a disability and affects over 50
      million individuals in the United States. Rates of spine surgeries performed to address
      degenerative spine conditions have increased markedly. A subset of patients experience poor
      pain, functional, or quality of life outcomes after surgery.

      This study will adapt and evaluate the feasibility and potential benefits of both a
      one-on-one and a group-delivered, face-to-face telehealth, mindfulness intervention for
      patients recovering from lumbar spine surgery. The goals of the intervention are to improve
      short and long-term pain management, reduce the need for long-term pain medications, and
      improve physical and psychological well-being after surgery. The study will result in a
      refined intervention manual based on feasibility, participant exit interviews and
      satisfaction surveys which will be piloted in a future randomized controlled trial.
    

Detailed description: 
      We will conduct a two-arm, nonrandomized, mixed-methods trial to refine a telehealth
      mindfulness-based intervention (MBI) for patients recovering from spine surgery. The
      procedures will be as follows:

        1. Recruit, consent and enroll up to 26 patients over a period of 8 months who are planning
           to have their first lumbar spine surgery for a degenerative spine condition at the
           Vanderbilt Comprehensive Spine Center. Recruitment will occur at a routine preoperative
           clinic visit or over the phone, with the spine surgeon's permission to approach the
           patient.

        2. Two weeks after enrolled patients complete surgery, they will meet with an
           interventionist for eight, weekly one-on-one or group-delivered telehealth MBI sessions
           over a Zoom online telehealth platform. Sessions will be 75 minutes long (90 minutes for
           the first session). Sessions will be audio recorded and the interventionists will be
           supervised weekly.

        3. Participants will complete self-report assessments prior to surgery, two weeks after
           surgery (pre-intervention) and three months after surgery (post-intervention).

        4. After completing the intervention, participants will complete an intervention
           satisfaction survey and an audio-recorded 30-minute semi-structured interview over the
           phone to provide feedback regarding their experience with the intervention components
           and relevance to their postoperative recovery.

        5. We will code and analyze interview data continuously (every 2-4 interviews) until we
           reach data saturation and then integrate results from interviews and self-report surveys
           to determine relevant intervention adaptations, constructing a refined intervention
           protocol for pilot testing in a randomized controlled trial. We anticipate needing
           approximately 13-20 participants to complete interviews to reach data saturation (i.e.
           no new, relevant information obtained from interviews).
    

Intervention name(s): Individual telehealth mindfulness; Group telehealth mindfulness
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants who enroll and complete lumbar spine surgery will participate in a one-on-one telehealth-delivered (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight, weekly sessions lasting 75 minutes each (except the first session which lasts 90 minutes).; Participants who enroll and complete lumbar spine surgery will participate in a group-delivered telehealth (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight, weekly sessions lasting 90 minutes each.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-arm, nonrandomized, repeated measures design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mindfulness; Telehealth; Mindfulness-based intervention