MBCT-T for Preoperative Pain

N/A

Recruiting

Led By Lisa Doan, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 8

Awards & highlights

No Placebo-Only Group

Summary

This trial will explore how mindfulness-based cognitive therapy (MBCT-T) can reduce preoperative pain catastrophizing in patients scheduled for spine surgery. A focus group and single-arm trial will be conducted. Follow-up will be two weeks post-op.

Who is the study for?

This trial is for adults with high pain catastrophizing who are scheduled for specific lumbar spine surgeries and require an inpatient stay. Participants must be able to give informed consent, have telephone and internet access, and score at least 20 on the PCS (a measure of pain-related thoughts). People with certain mental health conditions or cognitive impairments, non-English speakers, or those with recent self-harm/suicidality are not eligible.

What is being tested?

The study is testing a program called Mindfulness-based Cognitive Therapy delivered over the phone (MBCT-T) before surgery to see if it helps manage pain better after spine surgery. The first phase adapts MBCT-T for patients through a small focus group. In the second phase, participants receive four weekly sessions before their operation and are then monitored for two weeks after.

What are the potential side effects?

Since MBCT-T involves therapy sessions over the phone without medication or invasive procedures, significant side effects aren't expected. However, discussing painful emotions could potentially cause temporary distress or discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Client Satisfaction Questionnaire (CSQ-8) Score

Secondary study objectives

Change in Pain Catastrophizing Scale (PCS) Score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: MBCT-TExperimental Treatment1 Intervention

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.

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