The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery

March 14, 2016 updated by: Meir Medical Center

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

Unknown

Conditions

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kfar Saba, Israel
        • Recruiting
        • Meir MC
        • Contact:
        • Sub-Investigator:
          • Linor Shushan Amir, MA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients who intended to undergo spinal surgery

Exclusion Criteria:

  • patients who does not speak Hebrew language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

June 8, 2014

First Submitted That Met QC Criteria

September 10, 2014

First Posted (Estimate)

September 11, 2014

Study Record Updates

Last Update Posted (Estimate)

March 15, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

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.

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