Postoperative Telehealth Mindfulness Intervention After Spine Surgery

NCT ID: NCT04648683

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-21
• Study Completion Date: 2022-08-25

Brief 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).

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Individual telehealth mindfulness

Telehealth mindfulness sessions delivered one-on-one with mindfulness therapist

Group Type: EXPERIMENTAL

Individual telehealth mindfulness

Intervention Type: BEHAVIORAL

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).

Group Telehealth Mindfulness

Telehealth mindfulness sessions delivered in a small-group format with mindfulness therapist

Group Type: EXPERIMENTAL

Group telehealth mindfulness

Intervention Type: BEHAVIORAL

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.

Interventions

Individual telehealth mindfulness

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).

Intervention Type: BEHAVIORAL

Group telehealth mindfulness

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. English-speaking adults

2. Between the ages of 18 and 90

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

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Carrie Brintz

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carrie E Brintz, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt Spine Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K23AT011569

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201486

Identifier Type: -

Identifier Source: org_study_id