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

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

Tracking Information

• First Submitted Date: January 31, 2006
• First Posted Date: February 2, 2006
• Last Update Posted Date: July 23, 2019
• Actual Study Start Date: August 2005
• Actual Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 31, 2006): Beck Depression Inventory
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: January 31, 2006): NDDI
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Group Cognitive Behavioral Therapy to Treat Depression in an Epilepsy Clinic Setting
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Epilepsy
• Depressive Disorder

• Intervention: Behavioral: Cognitive Behavioral Therapy (CBT) in a Group Format
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 19, 2019): 25
• Original Enrollment (submitted: January 31, 2006): 30
• Actual Study Completion Date: January 2007
• Actual Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
• Eligibility Criteria: 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

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00285740
• Other Study ID Numbers: 2903; 34121
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Stanford University
• Study Sponsor: Stanford University
• Collaborators: Epilepsy Foundation

Investigators

• Principal Investigator: John J Barry; Stanford University

• PRS Account: Stanford University
• Verification Date: July 2019