- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02237105
The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery
This study is designed to examine the efficacy of Cognitive Behavioral Therapy (CBT) on the outcome of spinal surgery.
The goal of this treatment is to change the coping style, thoughts, behavior and adaptive perception of the patient, and to replace them with an adaptive style.
The patients in this study will be randomly divided into two groups. One group will undergo Cognitive Behavioral Therapy (CBT) before having spinal surgery. The other group will be a control group, and will not have any psychological intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kfar Saba, Israel
- Recruiting
- Meir MC
-
Contact:
- Shushan Amir
- Phone Number: 09-7472966
- Email: linor.amir@clalit.org.il
-
Sub-Investigator:
- Linor Shushan Amir, MA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients who intended to undergo spinal surgery
Exclusion Criteria:
- patients who does not speak Hebrew language
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Behavioral Therapy Group
This group will undergo Cognitive Behavioral Therapy (CBT) before having spinal surgery
|
Cognitive Behavioral Therapy
|
No Intervention: control group
This group will not undergo any psychological intervention before the spinal surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BSI questionnaire in spine preoperative patients .
Time Frame: 24 months
|
assessment of emotional state in spine preoperative patients will be measured by analysis of BSI questionnaire
|
24 months
|
OSWESTRY questionnaire in spine preoperative patients
Time Frame: 24 months
|
Assessment of disability in spine preoperative patients will be measured by analysis of OSWESTRY questionnaire
|
24 months
|
SF 36 questionnaire in spine preoperative patients
Time Frame: 24 months
|
assessment of well being in preoperative patients will be measured by analysis of SF36 questionnaire
|
24 months
|
VAS scale in spine preoperative patients
Time Frame: 24 months
|
Assessment of pain intensity in spine preoperative patients will be measured by analysis of VAS scale
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BSI questionnaire in spine postoperative patients
Time Frame: 24 months
|
assessment of emotional state in spine postoperative patients will be measured by analysis of BSI questionnaire
|
24 months
|
OSWESTRY questionnaire in spine postoperative patients
Time Frame: 24 months
|
Assessment of disability in spine postoperative patients will be measured by analysis of OSWESTRY questionnaire
|
24 months
|
SF 36 questionnaire in postoperative patients
Time Frame: 24 months
|
Assessment of well being in spine postoperative patients will be measured by analysis of SF 36 questionnaire
|
24 months
|
VAS scale in spine postoperative patients
Time Frame: 24 months
|
Assessment of pain intensity in spine postoperative patients will be measured by analysis of VAS scale
|
24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMC14276-13CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
University of Colorado, BoulderNational Institutes of Health (NIH); Radiological Society of North America; Psychophysiologic... and other collaboratorsCompletedChronic Pain | Back Pain Lower Back Chronic | Back Pain, LowUnited States
-
Marco LoggiaNational Institute of Neurological Disorders and Stroke (NINDS)CompletedLow Back Pain | Pain, Chronic | Back Pain Lower Back Chronic | Back Pain With Radiation | Back Pain Without Radiation | Back AcheUnited States
-
Carilion ClinicVirginia Center for Health InnovationEnrolling by invitationBack Pain | Back Pain Lower Back Chronic | Back Pain, LowUnited States
-
Dan RhonNational Center for Complementary and Integrative Health (NCCIH); 59th Medical... and other collaboratorsRecruitingLow Back Pain | Chronic Pain | Surgery | Back Pain Lower Back Chronic | Back Pain, LowUnited States
-
Federal University of Minas GeraisRecruitingBack Pain | Low Back Pain | Chronic Low-back Pain | Back Pain Lower Back ChronicBrazil
-
Canandaigua VA Medical CenterFoot Levelers, Inc.; Northeast College of Health SciencesTerminatedBack Pain Lower Back ChronicUnited States
-
Brigham and Women's HospitalMassachusetts General Hospital; National Center for Complementary and Integrative...CompletedLow Back Pain | Low Back Pain, Recurrent | Back Pain Lower Back ChronicUnited States
-
Balgrist University HospitalUniversity of Zurich, Epidemiology, Biostatistics and Prevention InstituteCompletedBack Pain | Back Pain With Radiation | Back Pain, LowSwitzerland
Clinical Trials on Cognitive Behavioral Therapy
-
Eleos HealthMissouri Department of Mental HealthCompletedMood Disorders | Anxiety DisordersUnited States
-
Regionsenter for barn og unges psykiske helseThe Research Council of NorwayCompletedGeneralized Anxiety Disorder | Social Phobia | Separation Anxiety DisorderNorway
-
Claremont McKenna CollegeUniversity of California, Los AngelesCompleted
-
University of South FloridaObsessive Compulsive FoundationCompletedObsessive Compulsive Disorder | Stepped Care Cognitive Behavioral TherapyUnited States
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Completed
-
University of RochesterNational Institute of Nursing Research (NINR)CompletedDepression | Sleep | Stress Disorders, Post-TraumaticUnited States
-
University of PittsburghWithdrawnPsychosis | Prodromal Symptoms | Prodromal Stage | Prodromal StatesUnited States
-
Duke UniversityCompleted
-
The University of Texas Health Science Center at...59th Medical Wing; Brooke Army Medical Center; South Texas Veterans Health Care...CompletedCombat Disorders | Post-Traumatic Stress Disorders | Stress DisordersUnited States
-
UConn HealthCompletedObsessive-Compulsive DisorderUnited States