Study Stopped
Temporarily suspended.
MBCT-T for Preoperative Pain Catastrophizing and Pain Outcomes After Spine Surgery
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
1 other identifier
interventional
25
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pain
Started Jan 2020
Longer than P75 for not_applicable pain
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 9, 2020
CompletedFirst Submitted
Initial submission to the registry
May 25, 2023
CompletedFirst Posted
Study publicly available on registry
June 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
January 6, 2026
January 1, 2026
7.4 years
May 25, 2023
January 2, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants who Attend More than Half of Scheduled Sessions
Up to Week 8 (End of Intervention)
Client Satisfaction Questionnaire (CSQ-8) Score
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.
Week 8 (End of Intervention)
Secondary Outcomes (1)
Change in Pain Catastrophizing Scale (PCS) Score
Baseline, Week 8
Study Arms (1)
MBCT-T
EXPERIMENTALParticipants 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
NYU Langone Health
Brooklyn, New York, 11220, United States
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa Doan, MD
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2023
First Posted
June 5, 2023
Study Start
January 9, 2020
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
January 6, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to lisa.doan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: lisa.doan@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.