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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comparison Group | Active Comparator | Patients with a zero risk score will serve as a comparison group (N=20). |
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| Sham Treatment | Active Comparator | All patients at risk will be stratified by risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20). |
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| CBT | Active Comparator | All patients at risk will be stratified by risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Distress and Risk Assessment Method (DRAM) | The DRAM assesses and profiles patients: those showing no psychological distress, those at risk of developing major psychological overlay, and those that are distressed. | 2 Years |
| Pain Catastrophizing Scale (PCS) | The pain catastrophizing scale quantifies an individual's pain experience, their tendency to magnify the threat value of pain, and their ability to prevent pain-related thoughts surrounding a painful event. | 2 Years |
| Outcome Expectation question (OEQ) | The OEQ will be a single item question: "I strongly believe that I will recover quickly from my surgery. Responses are score on a 5-point scale, ranging from 1 (strongly disagree) to 5 (strongly agree). Outcome expectations have been shown to be one of the strongest psychological predictors affecting recovery from musculoskeletal injuries. | 2 Years |
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Inclusion Criteria:
Patients at Risk:
Inclusion Criteria for patients with zero risk:
Exclusion Criteria:
Exclusion Criteria for patients at risk:
Exclusion Criteria for patients with zero risk:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Passias, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Sham Therapy | Behavioral | 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. |
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