EpilepsyNCT00285740
Group Cognitive Behavioral Therapy to Treat Depression in an Epilepsy Clinic Setting
A study testing Cognitive Behavioral Therapy (CBT) in a Group Format in people with Epilepsy and Depressive Disorder, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy, Depressive Disorder
- What is being tested?
- Cognitive Behavioral Therapy (CBT) in a Group Format
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Jan 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
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.
Read the 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.
- Conditions
- Epilepsy, Depressive Disorder
- Being tested
- Cognitive Behavioral Therapy (CBT) in a Group Format
- Medical subject headings
- Epilepsy, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT) in a Group FormatBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory
Secondary outcomes (1)
NDDI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startAug 2005
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Epilepsy Foundation
- Responsible party
- Sponsor
- Investigators
- John J Barry, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285740
- Sponsor's protocol ID
- 2903
- Other IDs
- 34121
- Status last verified
- Jul 2019
- First submitted
- 31 Jan 2006
- Last updated
- 23 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Cognitive Behavioral Therapy to Treat Depression in an Epilepsy Clinic Setting
- ClinicalTrials.gov ID
- NCT00285740
- Acronym / sponsor ID
- 2903
- Conditions
- Epilepsy, Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Epilepsy Foundation
- Study start
- Aug 2005 (actual)
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 2 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) in a Group Format | Behavioural | – |
Primary outcome
Beck Depression Inventory
1 secondary outcome
NDDI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John J Barry principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT) in a Group Format in people with Epilepsy and Depressive Disorder, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.