Postoperative Telehealth Mindfulness Intervention After Spine Surgery

NCT04648683 | Completed Results

• 2 other identifiers: 201486K23AT011569
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Mindfulness; Telehealth; Mindfulness-based intervention

Outcome Measures

Primary Outcomes (3)

• Feasibility - Study Retention

  Percentage of participants enrolled who complete the study

  3 months following lumbar spine surgery

• Feasibility - Session Attendance

  Percent of sessions attended out of 8

  3 months following lumbar spine surgery

• Acceptability - Satisfaction With Intervention

  Nine items assessing satisfaction with the postsurgical telehealth mindfulness intervention (sum of item scores; higher scores indicate higher satisfaction; scores can range from 7 to 55)

  3 months following lumbar spine surgery

Secondary Outcomes (13)

• Pain Bothersomeness

  3 months postoperative

• Pain Interference Short-form 4a

  3 months postoperative

• Overall Pain Intensity

  3 months postoperative

• Back and Leg Pain Intensity

  3 months postoperative

• Self-reported Opioid Medication Use

  3 months postoperative

Study Arms (2)

Individual telehealth mindfulness

EXPERIMENTAL

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

Behavioral: Individual telehealth mindfulness

Group Telehealth Mindfulness

EXPERIMENTAL

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

Behavioral: Group telehealth mindfulness

Interventions

Individual telehealth mindfulness 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).

Individual telehealth mindfulness

Group telehealth mindfulness 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.

Group Telehealth Mindfulness

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking adults
• Between the ages of 18 and 90
• 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
• Current/history of a primary psychotic or major thought disorder or hospitalization for reasons related to psychosis
• 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)

Sponsors & Collaborators

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

Study Sites (1)

Vanderbilt Spine Center

Nashville, Tennessee, 37204, 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

Results Point of Contact

• Title: Carrie Brintz
• Organization: Vanderbilt University Medical Center

carrie.brintz@vumc.org

615-875-9885

Study Officials

• Carrie E Brintz, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two-arm, nonrandomized, repeated measures design

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 1, 2020
• Study Start: December 21, 2021
• Primary Completion: August 25, 2022
• Study Completion: August 25, 2022
• Last Updated: September 26, 2023
• Results First Posted: September 26, 2023

Record last verified: 2023-09

Locations

US (1)