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

Not Applicable

Recruiting

• Conditions: Pain
• Interventions: Behavioral: Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T)

• Registration Number: NCT05888025
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-09
• Study First Submitted: 2023-05-25
• Study First Submitted QC: 2023-05-25
• Study First Posted: 2023-06-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2026-06
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MBCT-T	Telephone-Delivered Mindfulness-based Cognitive Therapy (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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants who Attend More than Half of Scheduled Sessions	Up to Week 8 (End of Intervention)
Client Satisfaction Questionnaire (CSQ-8) Score	Week 8 (End of Intervention)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Pain Catastrophizing Scale (PCS) Score	Baseline, Week 8	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States