SUSPENDED

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2020-01-09
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT05888025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * PCS score ≥ 20
  3. * Able to provide voluntary informed consent
  4. * Telephone access
  5. * Internet access
  1. * Non-English speaking
  2. * Cognitively impaired, by history
  3. * Bipolar disorder
  4. * Borderline personality disorder
  5. * Active post-traumatic stress disorder
  6. * Schizoaffective disorder or any other disorder characterized by delusions or hallucinations
  7. * History of self-harm or suicidality in past three months

Contacts and Locations

Principal Investigator

Lisa Doan, MD
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Lisa Doan, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-09
Study Completion Date2027-10

Study Record Updates

Study Start Date2020-01-09
Study Completion Date2027-10

Terms related to this study

Additional Relevant MeSH Terms

  • Pain