CBTvsSSRI: CBT Versus Selective Serotonin Reuptake Inhibitor For Treatment Of Depression In Temporal Lobe Epilepsy Patients

Sponsor

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez (Other)

Overall Status

Completed

CT.gov ID

NCT02262156

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to compare the effect of group-cognitive-behavioral therapy (CBT)versus treatment as usual with the selective serotonin reuptake inhibitor sertraline, in patients with diagnosis of temporal lobe epilepsy (TLE) and depressive disorder.

Condition or Disease	Intervention/Treatment	Phase
Depression Epilepsy, Temporal Lobe	Other: Cognitive behavioral therapy Drug: SSRI	N/A

Detailed Description

patients with temporal lobe epilepsy and depression will be enrolled into one of two treatment modality. The first group will receive 12 group cognitive behavioral sessions. CBT is a psychotherapy focused on the recognition and change of distorted thoughts and maladaptive behaviors.

The second group will receive treatment with the selective serotonin reuptake inhibitor sertraline or citalopram for 12 weeks. This antidepressant is wide used to treat depression in patients with TLE.

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Treatment Of Depression In Patients With Temporal Lobe Epilepsy: Comparative Study Of Cognitive Behavioral Therapy Vs. Selective Serotonin Reuptake Inhibitors

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive behavioral Therapy CBT program to be used in group modality that focused on managing symptoms of depression in patients with epilepsy. 12 CBT sessions, consisting of one weekly 90-minute session for 12 consecutive weeks.	Other: Cognitive behavioral therapy The CBT group will receive 12 weekly 90-minute sessions. Each session will be given in group form by one certified CBT therapist and one neuropsychiatrist in training on group therapy. The CBT structure include psychoeducation, addressing dysfunctional thoughts and maladaptive behaviors; problem solving techniques, assertiveness, coping strategies and depression relapse prevention Other Names: CBT
Active Comparator: Selective serotonin euptake inhibitor Patients will receive a SSRI (sertraline or citalopram) for 12 weeks. Dose will be adjusted every 4 weeks according to medical criteria.	Drug: SSRI Patients will receive the "treatment as usual" with a SSRI: sertraline or citalopram. In patients already taking antidepressants for more than 8 weeks before enrollment but still experiencing depressive symptoms, treatment could be optimized either by augmenting the dose of his antidepressant or by changing to one of the SSRI mentioned. Other Names: selective serotonin reuptake inhibitor antidepressant

Arm

Intervention/Treatment

Experimental: Cognitive behavioral Therapy

CBT program to be used in group modality that focused on managing symptoms of depression in patients with epilepsy. 12 CBT sessions, consisting of one weekly 90-minute session for 12 consecutive weeks.

Other: Cognitive behavioral therapy

The CBT group will receive 12 weekly 90-minute sessions. Each session will be given in group form by one certified CBT therapist and one neuropsychiatrist in training on group therapy. The CBT structure include psychoeducation, addressing dysfunctional thoughts and maladaptive behaviors; problem solving techniques, assertiveness, coping strategies and depression relapse prevention

Other Names:

CBT

Active Comparator: Selective serotonin euptake inhibitor

Patients will receive a SSRI (sertraline or citalopram) for 12 weeks. Dose will be adjusted every 4 weeks according to medical criteria.

Drug: SSRI

Patients will receive the "treatment as usual" with a SSRI: sertraline or citalopram. In patients already taking antidepressants for more than 8 weeks before enrollment but still experiencing depressive symptoms, treatment could be optimized either by augmenting the dose of his antidepressant or by changing to one of the SSRI mentioned.

Other Names:

selective serotonin reuptake inhibitor

antidepressant

Outcome Measures

Primary Outcome Measures

Change in Beck Depression Inventory score [baseline, 6 weeks and 12 weeks]

Secondary Outcome Measures

Quality of Life in Epilepsy Scale [baseline, 6 weeks and 12 weeks]
the quality of life in epilepsy scale measures the patients perceived quality of life. Higher score indicates better quality of life. score goes from 0 to 100
Hospital anxiety and depression scale (HADS) [baseline, 4weeks and 12 weeks]
the HADS measures severity of symptoms of anxiety and depression. Lower scores indicates less symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

With Major depressive disorder according to criteria from the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
Diagnosed with TLE according to the criteria of the International League Against Epilepsy
Literates had sign an informed consent
Patients on antidepressant treatments will be allowed to participate only if they had been at stable doses for more than 8 weeks and still show signs of significant depression

Exclusion Criteria:

Patients with high risk of suicide who required hospitalization
Patients who abused or are dependent on drugs
Those with a history of head trauma six months prior to the interview
Patients who have any condition that would prevent them from understanding the study or the psychotherapeutic process, such as mental retardation, psychosis, delirium, dementia, etc
Patients who have previously received CBT
Patients who have started, an antidepressant drug the last 8 weeks