Telehealth Mindfulness After Spine Surgery (NCT05698914) | Clinical Trial Compass
CompletedNot Applicable
Telehealth Mindfulness After Spine Surgery
United States67 participantsStarted 2023-02-22
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. English-speaking adults
✓. Aged 18 years and older
✓. 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
Exclusion criteria
✕. Microsurgical technique as the primary procedure (i.e. isolated laminotomy or microdiscectomy)
✕. Having surgery for the primary indication of a spinal deformity
What they're measuring
1
Enrollment Rate
Timeframe: Through enrollment completion, approximately 21 months
2
Participant study retention
Timeframe: Through study completion, approximately 28 months
✕. 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 (e.g. Schizophrenia, brief psychotic disorder, delusional disorder). Medication-induced psychosis is not exclusionary.
✕. 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)