NCT03183713

The Confounding Burden of Psychological Impairments in Cervical Spine Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center prospective randomized investigation of patients undergoing surgical arthrodesis for single or multi-level cervical disease, resulting in cervical radiculopathy. Patients indicated for surgery for cervical degenerative disease (CDD) will be screened for yellow flags using validated tools to assess pain. Cognitive-behavioral therapy (CBT) will be used to modify yellow flags in spine patients. All patients at risk will be stratified by risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20). The goal of this study is to unmask the relationship between psychological distress and clinical outcomes in patients undergoing surgical treatment for cervical degenerative disease resulting in combinations of neck pain and radiculopathy, and to determine the effectiveness of a brief psychological intervention on subset of patients who screen positive for psychological distress prior to their surgeries.

Conditions

• Cervical Spine Disease
• Psychological Impairment

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy	Psychologically symptomatic patients will then be randomized to 4-8 weeks of placebo phone calls (Group PS-PL-Sx) or 4-8 weeks of cognitive behavior therapy treatment (PS-CBT-Sx) based on a 1:1 randomization ratio. Subjects randomized to receive CBT before surgery will proceed to 6 sessions given within 4-8 weeks by a licensed psychologist specializing in pain. CBT sessions will be 30 minutes in length, and focus on empirically supported behavior management, problem solving, cognitive restructuring, and relaxation training. The first session will be performed in person, and the subsequent 5 sessions will be performed over the phone.
BEHAVIORAL	Sham Therapy	Study nurse will conduct six sessions (30 minutes/ session) over a 4-8 week time period. The first session will be performed in person, and the subsequent 5 sessions will be performed over the phone. Sham sessions will entail how to prepare for surgery and expectations for recovery, and will go over content that the treatment and control groups will receive in handout form.

Timeline

• Start date: 2017-06-05
• Primary completion: 2024-07-10
• Completion: 2024-07-10
• First posted: 2017-06-12
• Last updated: 2024-10-01

Locations

1 site across 1 country: United States