CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Individual telehealth mindfulness +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04648683
NCT04648683N/ACompleted

Postoperative Telehealth Mindfulness Intervention to Improve Pain-related Outcomes and Reduce Opioid Use After Lumbar Spine Surgery

Vanderbilt University Medical Center·interventional·Posted Dec 1, 2020·Updated Sep 26, 2023

In Brief

A clinical study evaluating Individual telehealth mindfulness and Group telehealth mindfulness for Chronic Low-back Pain and 3 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 1, 2020
Enrollment StartDec 21, 2021
Primary CompletionAug 25, 2022
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.6 years ago

Interventions

Individual telehealth mindfulnessbehavioral

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 mindfulnessbehavioral

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.