IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Group Cognitive Behavioral Therapy to Treat Depression in an Epilepsy Clinic Setting
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by Stanford University.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
Stanford University
Collaborator:
Epilepsy Foundation
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00285740
First received: January 31, 2006
Last updated: December 14, 2007
Last verified: December 2007
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | January 31, 2006 | |||
| Last Updated Date | December 14, 2007 | |||
| Start Date ICMJE | August 2005 | |||
| Primary Completion Date | Not Provided | |||
| Current Primary Outcome Measures ICMJE |
Beck Depression Inventory | |||
| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | Complete list of historical versions of study NCT00285740 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
NDDI | |||
| Original Secondary Outcome Measures ICMJE | Same as current | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | 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 | Not Provided | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
|||
| Condition ICMJE |
|
|||
| Intervention ICMJE | Behavioral: Cognitive Behavioral Therapy (CBT) in a Group Format | |||
| Study Arms | 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 | Unknown status | |||
| Enrollment ICMJE | 60 | |||
| Estimated Completion Date | January 2007 | |||
| Primary Completion Date | Not Provided | |||
| 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 |
|
|||
| Ages | 18 Years to 65 Years (Adult) | |||
| Accepts Healthy Volunteers | 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 | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Stanford University | |||
| Collaborators ICMJE | Epilepsy Foundation | |||
| Investigators ICMJE |
|
|||
| PRS Account | Stanford University | |||
| Verification Date | December 2007 | |||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
||||