Group Cognitive Behavioral Therapy to Treat Depression in an Epilepsy Clinic Setting
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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 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 |
Beck Depression Inventory | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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 |
|
|||
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 |
25 | |||
Original Enrollment ICMJE |
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 |
|
|||
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 |
|
|||
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 |