Mindfulness-based therapy for managing pain before spine surgery
A Pilot Proof of Concept, Single-Center Study of the Effects of Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T) on Preoperative Pain Catastrophizing and Pain Outcomes After Spine Surgery
This study is testing a phone-based mindfulness therapy to help people who worry a lot about pain before they have spine surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 2 sites (Brooklyn, New York and 1 other locations) |
| Trial ID | NCT05888025 on ClinicalTrials.gov |
What this trial studies
This study aims to adapt and evaluate a telephone-delivered mindfulness-based cognitive therapy (MBCT-T) for patients experiencing high levels of pain catastrophizing prior to undergoing spine surgery. In the first phase, a focus group will help tailor the therapy to the specific needs of the study population. The second phase involves a single-arm trial where participants will receive four weekly sessions of MBCT-T and will be monitored for pain outcomes for two weeks after their surgery.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for lumbar spine surgery who exhibit high levels of pain catastrophizing.
Not a fit: Patients with cognitive impairments or severe psychiatric disorders may not benefit from this therapy.
Why it matters
Potential benefit: If successful, this approach could help reduce pain catastrophizing and improve postoperative pain outcomes for patients undergoing spine surgery.
How similar studies have performed: While mindfulness-based interventions have shown promise in other contexts, this specific adaptation for preoperative pain catastrophizing is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Scheduled for one or two level lumbar spine surgery requiring an inpatient stay as well as patients having ambulatory 1 or 2 level lumbar spine surgeries * PCS score ≥ 20 * Able to provide voluntary informed consent * Telephone access * Internet access Exclusion Criteria: * Non-English speaking * Cognitively impaired, by history * Bipolar disorder * Borderline personality disorder * Active post-traumatic stress disorder * Schizoaffective disorder or any other disorder characterized by delusions or hallucinations * History of self-harm or suicidality in past three months
Where this trial is running
Brooklyn, New York and 1 other locations
- NYU Langone Health — Brooklyn, New York, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Lisa Doan, MD — NYU Langone Health
- Study coordinator: Lisa Doan, MD
- Email: Lisa.doan@nyulangone.org
- Phone: 212-263-5072
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.