The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedFirst Posted
Study publicly available on registry
September 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedMarch 15, 2016
March 1, 2016
1.7 years
June 8, 2014
March 14, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
BSI questionnaire in spine preoperative patients .
assessment of emotional state in spine preoperative patients will be measured by analysis of BSI questionnaire
24 months
OSWESTRY questionnaire in spine preoperative patients
Assessment of disability in spine preoperative patients will be measured by analysis of OSWESTRY questionnaire
24 months
SF 36 questionnaire in spine preoperative patients
assessment of well being in preoperative patients will be measured by analysis of SF36 questionnaire
24 months
VAS scale in spine preoperative patients
Assessment of pain intensity in spine preoperative patients will be measured by analysis of VAS scale
24 months
Secondary Outcomes (4)
BSI questionnaire in spine postoperative patients
24 months
OSWESTRY questionnaire in spine postoperative patients
24 months
SF 36 questionnaire in postoperative patients
24 months
VAS scale in spine postoperative patients
24 months
Study Arms (2)
Cognitive Behavioral Therapy Group
EXPERIMENTALThis group will undergo Cognitive Behavioral Therapy (CBT) before having spinal surgery
control group
NO INTERVENTIONThis group will not undergo any psychological intervention before the spinal surgery.
Interventions
Cognitive Behavioral Therapy
Eligibility Criteria
You may qualify if:
- patients who intended to undergo spinal surgery
You may not qualify if:
- patients who does not speak Hebrew language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Meir MC
Kfar Saba, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2014
First Posted
September 11, 2014
Study Start
September 1, 2014
Primary Completion
May 1, 2016
Study Completion
November 1, 2016
Last Updated
March 15, 2016
Record last verified: 2016-03