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

NCT ID: NCT05888025

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-09
• Study Completion Date: 2027-10-31

Brief 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.

Conditions

Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T)

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Doan, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

Brooklyn, New York, United States

NYU Langone Health

New York, New York, United States

Countries

United States

Other Identifiers

19-00339

Identifier Type: -

Identifier Source: org_study_id