MBCT-T for Preoperative Pain Catastrophizing and Pain Outcomes After Spine Surgery

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05888025
• Other study ID #: 19-00339
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2020
• Est. completion date: October 2026

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: Lisa Doan, MD
• Phone: 212-263-5072
• Email: Lisa.doan[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a two phase study. In phase 1, a focus group (N=5) will be conducted to adapt MBCT-T for use in the study population. In phase 2, a single-arm trial will be conducted examining four, weekly sessions of preoperative MBCT-T in subjects with high pain catastrophizing scheduled for spine surgery (N=20). Subjects will then be followed for two weeks postoperatively.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: October 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Behavioral:
• Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T)
MBCT-T will be delivered in groups of four to eight subjects by telephone using a conference line with NYULH WebEx. Participants will receive a workbook containing session content and home practice logs and audio guides for home practice. Subjects will complete individual orientation sessions with the MBCT-T facilitator prior to start of the group sessions. The four subsequent weekly group sessions are approximately 90 minutes long. Participants will be encouraged to practice daily meditation in between group sessions for 20-30 minutes, six days per week

Locations

Country	Name	City	State
United States	NYU Langone Health	Brooklyn	New York
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants who Attend More than Half of Scheduled Sessions		Up to Week 8 (End of Intervention)
Primary	Client Satisfaction Questionnaire (CSQ-8) Score	The CSQ-8 is an 8-item questionnaire assessing satisfaction with the intervention. Each item is rated on a 4-point scale from 1-4. The total score is the sum of responses and ranges from 8 to 32, with the higher number indicating greater satisfaction.	Week 8 (End of Intervention)
Secondary	Change in Pain Catastrophizing Scale (PCS) Score	The PCS is a 13-item questionnaire designed to quantify an individual's pain experience, asking about how they feel and what they think about when they are in pain. Each item is rated on a 5-point scale ranging from 0 (not at all) to 4 (all the time). The total score is the sum of responses and ranges from 0 to 52. Higher scores represent greater pain catastrophizing.	Baseline, Week 8