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

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT05888025
Collaborator
(none)
25
1
1
52.7
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 9, 2020
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants who Attend More than Half of Scheduled Sessions [Up to Week 8 (End of Intervention)]

  2. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT05888025
Other Study ID Numbers:
  • 19-00339
First Posted:
Jun 5, 2023
Last Update Posted:
Jun 5, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 5, 2023