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Group Cognitive Behavioral Therapy to Treat Depression in an Epilepsy Clinic Setting

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ClinicalTrials.gov Identifier: NCT00285740
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
Epilepsy Foundation
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date  ICMJE January 31, 2006
First Posted Date  ICMJE February 2, 2006
Last Update Posted Date July 23, 2019
Actual Study Start Date  ICMJE August 2005
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2006)
Beck Depression Inventory
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2006)
NDDI
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Group Cognitive Behavioral Therapy to Treat Depression in an Epilepsy Clinic Setting
Official Title  ICMJE Not Provided
Brief Summary This study involves a form of group therapy called Cognitive Behavioral Therapy or CBT for depressed patients with Epilepsy. The CBT groups will be tailored for an epilepsy clinic population. There are 12 sessions of therapy in the study held once a week for 12 weeks.
Detailed Description Depression is frequent in PWE and often missed for unclear reasons. Busy neurology clinics and their overworked physicians often lack psychiatric backup that may make inquiring about psychological issues problematic. In the psychiatric community, awareness of the need for depression intervention in the primary care clinic has been recognized for many years and several treatment models exist. This study will attempt to use one such model, i.e. Cognitive-Behavioral Therapy (CBT) using a group format and tailoring its use for an epilepsy clinic population.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Epilepsy
  • Depressive Disorder
Intervention  ICMJE Behavioral: Cognitive Behavioral Therapy (CBT) in a Group Format
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2019)
25
Original Enrollment  ICMJE
 (submitted: January 31, 2006)
30
Actual Study Completion Date  ICMJE January 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Inclusion Criteria::- Patients will be screened with the Beck Depression Inventory. Those reaching the positive cut-off score of 11 (indicating at least a mild depression) will be entered into the study. Patients entered on antidepressants will be held at a stable dosage. Anti-epileptic drugs will also be maintained on the same dosage at entry into the study when possible clinically, after consultation with their neurologist. Exclusion Criteria:- Patients will be excluded if there is any active serious medical conditions, Standard Score<70 as assessed via the Wide Range Achievement Test, psychotic or substance abuse issues, those who are unable to maintain a stable dose of medications for the duration of study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00285740
Other Study ID Numbers  ICMJE 2903
34121
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Epilepsy Foundation
Investigators  ICMJE
Principal Investigator: John J Barry Stanford University
PRS Account Stanford University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP