MBCT-T for Preoperative Pain Catastrophizing and Pain Outcomes After 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 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.

Study Overview

• Status: Suspended
• Conditions: Pain
• Intervention / Treatment: Behavioral: Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T)

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11220
      • NYU Langone Health
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MBCT-T; Participants with high pain catastrophizing who are scheduled for spine surgery will receive four weekly sessions of preoperative telephone-delivered mindfulness-based cognitive therapy (MBCT-T). They will then be followed for two weeks postoperatively.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants who Attend More than Half of Scheduled Sessions		Up to Week 8 (End of Intervention)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Lisa Doan, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2020
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: 19-00339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: lisa.doan@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to lisa.doan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No