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Cognitive Behavioral Therapy for Cervical Spine Disease
N/A
Waitlist Available
Led By Peter Passias, 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 2 years
Awards & highlights
Study Summary
This trial is testing whether cognitive-behavioral therapy can help improve outcomes for people undergoing surgery for cervical degenerative disease.
Who is the study for?
This trial is for adults with cervical disc herniation, spinal stenosis, or degenerative diseases needing spine surgery. They must have neck and arm symptoms, understand English, and be reachable by phone. Excluded are those with recent spine surgeries, other medical conditions causing neck pain, severe psychiatric issues or substance dependency.Check my eligibility
What is being tested?
The study tests if Cognitive Behavioral Therapy (CBT) can improve outcomes in patients with psychological distress undergoing cervical spine surgery. It compares CBT to a sham treatment in two groups of 20 patients each who are randomly assigned.See study design
What are the potential side effects?
Since the interventions involve therapy rather than medication, side effects may include discomfort during sessions or emotional distress due to discussing personal issues but no physical side effects like those from drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Distress and Risk Assessment Method (DRAM)
Outcome Expectation question (OEQ)
Pain Catastrophizing Scale (PCS)
Trial Design
3Treatment groups
Active Control
Group I: CBTActive Control1 Intervention
All patients at risk will be stratified by risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20).
Group II: Sham TreatmentActive Control1 Intervention
All patients at risk will be stratified by risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20).
Group III: Comparison GroupActive Control1 Intervention
Patients with a zero risk score will serve as a comparison group (N=20).
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,713 Total Patients Enrolled
Peter Passias, MDPrincipal InvestigatorNYU Langone Health
2 Previous Clinical Trials
137 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- There are certain patients who may be at risk for participating in the study.I have been diagnosed with cervical disc disease confirmed by imaging.Your kidney function is severely impaired, with a measurement called NDI above 20%.I experience both neck and arm pain, including numbness or weakness.I have a severe neck or spine deformity according to specific medical standards.You have recently struggled with drug or substance addiction that could affect your ability to participate in the study.I have had surgery to fuse bones in my neck.I cannot undergo surgery for my neck condition.I do not have AIDS, HIV, or active hepatitis.I am currently being treated for spine issues and haven't had spine surgery in the last 6 months.My back pain is due to a specific spine condition like herniated disc or spinal stenosis.I am scheduled for elective neck surgery involving up to 5 spinal levels.You must be able to understand and read English.I currently have a spinal or pelvic fracture.I currently have an infection.I have a chronic inflammatory condition affecting my spine.You have a history of severe mental illness or psychological issues that could affect your participation in the study, and your score on the DRAM screening tool is over 33.I can be reached by phone during the study.My neck pain is due to an injury, unknown cause, tumor, weak bones, or another health issue.
Research Study Groups:
This trial has the following groups:- Group 1: CBT
- Group 2: Sham Treatment
- Group 3: Comparison Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for individuals to become involved with this research initiative currently?
"As per the clinicaltrials.gov records, this research project is accepting participants right now. The trial was first seen on June 5th 2017 and underwent its most recent update on April 1st 2022."
Answered by AI
How many people are enrolled in this trial?
"Affirmative. Clinicaltrials.gov data verifies that, since first being announced on June 5th 2017, this trial has been actively recruiting applicants to fill its 60-person quota at one medical centre."
Answered by AI
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