The Confounding Burden of Psychological Impairments in Cervical Spine Surgery

NACompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

June 5, 2017

Primary Completion Date

July 10, 2024

Study Completion Date

July 10, 2024

Conditions
Cervical Spine DiseasePsychological Impairment
Interventions
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.

Trial Locations (1)

10016

New York University School of Medicine, New York

All Listed Sponsors
lead

NYU Langone Health

OTHER

NCT03183713 - The Confounding Burden of Psychological Impairments in Cervical Spine Surgery | Biotech Hunter | Biotech Hunter