<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02237105</url>
  </required_header>
  <id_info>
    <org_study_id>MMC14276-13CTIL</org_study_id>
    <nct_id>NCT02237105</nct_id>
  </id_info>
  <brief_title>The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery</brief_title>
  <official_title>The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to examine the efficacy of Cognitive Behavioral Therapy (CBT) on the&#xD;
      outcome of spinal surgery.&#xD;
&#xD;
      The goal of this treatment is to change the coping style, thoughts, behavior and adaptive&#xD;
      perception of the patient, and to replace them with an adaptive style.&#xD;
&#xD;
      The patients in this study will be randomly divided into two groups. One group will undergo&#xD;
      Cognitive Behavioral Therapy (CBT) before having spinal surgery. The other group will be a&#xD;
      control group, and will not have any psychological intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">November 2016</completion_date>
  <primary_completion_date type="Anticipated">May 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BSI questionnaire in spine preoperative patients .</measure>
    <time_frame>24 months</time_frame>
    <description>assessment of emotional state in spine preoperative patients will be measured by analysis of BSI questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OSWESTRY questionnaire in spine preoperative patients</measure>
    <time_frame>24 months</time_frame>
    <description>Assessment of disability in spine preoperative patients will be measured by analysis of OSWESTRY questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SF 36 questionnaire in spine preoperative patients</measure>
    <time_frame>24 months</time_frame>
    <description>assessment of well being in preoperative patients will be measured by analysis of SF36 questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS scale in spine preoperative patients</measure>
    <time_frame>24 months</time_frame>
    <description>Assessment of pain intensity in spine preoperative patients will be measured by analysis of VAS scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BSI questionnaire in spine postoperative patients</measure>
    <time_frame>24 months</time_frame>
    <description>assessment of emotional state in spine postoperative patients will be measured by analysis of BSI questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OSWESTRY questionnaire in spine postoperative patients</measure>
    <time_frame>24 months</time_frame>
    <description>Assessment of disability in spine postoperative patients will be measured by analysis of OSWESTRY questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF 36 questionnaire in postoperative patients</measure>
    <time_frame>24 months</time_frame>
    <description>Assessment of well being in spine postoperative patients will be measured by analysis of SF 36 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS scale in spine postoperative patients</measure>
    <time_frame>24 months</time_frame>
    <description>Assessment of pain intensity in spine postoperative patients will be measured by analysis of VAS scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Back Pain</condition>
  <arm_group>
    <arm_group_label>Cognitive Behavioral Therapy Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will undergo Cognitive Behavioral Therapy (CBT) before having spinal surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will not undergo any psychological intervention before the spinal surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy</intervention_name>
    <description>Cognitive Behavioral Therapy</description>
    <arm_group_label>Cognitive Behavioral Therapy Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who intended to undergo spinal surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who does not speak Hebrew language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Meir MC</name>
      <address>
        <city>Kfar Saba</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shushan Amir</last_name>
      <phone>09-7472966</phone>
      <email>linor.amir@clalit.org.il</email>
    </contact>
    <investigator>
      <last_name>Linor Shushan Amir, MA</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>June 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>March 14, 2016</last_update_submitted>
  <last_update_submitted_qc>March 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02237105
org study id: MMC14276-13CTIL
nct id: NCT02237105
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: BSI questionnaire in spine preoperative patients .
time frame: 24 months
description: assessment of emotional state in spine preoperative patients will be measured by analysis of BSI questionnaire
measure: OSWESTRY questionnaire in spine preoperative patients
time frame: 24 months
description: Assessment of disability in spine preoperative patients will be measured by analysis of OSWESTRY questionnaire
measure: SF 36 questionnaire in spine preoperative patients
time frame: 24 months
description: assessment of well being in preoperative patients will be measured by analysis of SF36 questionnaire
measure: VAS scale in spine preoperative patients
time frame: 24 months
description: Assessment of pain intensity in spine preoperative patients will be measured by analysis of VAS scale
measure: BSI questionnaire in spine postoperative patients
time frame: 24 months
description: assessment of emotional state in spine postoperative patients will be measured by analysis of BSI questionnaire
measure: OSWESTRY questionnaire in spine postoperative patients
time frame: 24 months
description: Assessment of disability in spine postoperative patients will be measured by analysis of OSWESTRY questionnaire
measure: SF 36 questionnaire in postoperative patients
time frame: 24 months
description: Assessment of well being in spine postoperative patients will be measured by analysis of SF 36 questionnaire
measure: VAS scale in spine postoperative patients
time frame: 24 months
description: Assessment of pain intensity in spine postoperative patients will be measured by analysis of VAS scale
arm group label: Cognitive Behavioral Therapy Group
arm group type: Experimental
description: This group will undergo Cognitive Behavioral Therapy (CBT) before having spinal surgery
arm group label: control group
arm group type: No Intervention
description: This group will not undergo any psychological intervention before the spinal surgery.
intervention type: Behavioral
intervention name: Cognitive Behavioral Therapy
description: Cognitive Behavioral Therapy
arm group label: Cognitive Behavioral Therapy Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Back Pain