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Behavioral Intervention

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Client Satisfaction Questionnaire (CSQ-8) Score

Percentage of Participants who Attend More than Half of Scheduled Sessions

Secondary outcome measures

Change in Pain Catastrophizing Scale (PCS) Score

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,369 Previous Clinical Trials

840,573 Total Patients Enrolled

7 Trials studying Pain

4,480 Patients Enrolled for Pain

Lisa Doan, MDPrincipal InvestigatorNYU Langone Health

5 Previous Clinical Trials

970 Total Patients Enrolled

Media Library

Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05888025 — N/A

Pain Clinical Trial 2023: Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T) Highlights & Side Effects. Trial Name: NCT05888025 — N/A

Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05888025 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction for enrollment in this clinical experiment?

"Entrants must be aged 18 or over and under 75 to meet the eligibility criterion of this clinical trial."

Answered by AI

Is there an open enrollment for the trial at this time?

"The clinicaltrials.gov records reveal that this research is currently in search of participants, having been initially posted on September 1st 2020 and last edited on May 25th 2023."

Answered by AI

Is eligibility open for the current clinical experiment?

"This medical study is looking for up to 25 individuals suffering from pain who are between 18 and 75 years old."

Answered by AI

To what extent is this research endeavor enrolling participants?

"Affirmative. The clinicaltrials.gov portal confirms that the study, which was first published on September 1st 2020, is actively seeking participants. In total there are 25 patients expected to enrol at a single medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "MBCT-T for Preoperative Pain Catastrophizing and Pain Outcomes After Spine Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05888025.