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

NYU Langone Health logo

NYU Langone Health

Status

Suspended

Conditions

Pain

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05888025
19-00339

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

MBCT-T
Experimental group
Description:
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.
Treatment:
Behavioral: Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T)

Trial contacts and locations

2

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Central trial contact

Lisa Doan, MD

Data sourced from clinicaltrials.gov

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