Evaluation of Three Continuation Therapies After ECT Concerning Efficacy and Cognition in Severly Depressed Patients
NCT00437385 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2011-11-10
Summary
The purpose of this study is to evaluate three different continuation treatments after acute ECT concerning efficacy and impact on cognition in severly depressed patients.
Conditions
Interventions
- DRUG
-
TCAs, SSRIs, NARIs, SNRIs, Lithium
Antidepressant, dosage, and duration are chosen due to the guidelines of the WFSBP (Bauer et al. 2002)
- PROCEDURE
-
Electroconvulsive therapy
ECT treatment is administered three times per week on non-successive weekdays and according to existing standards. Treatment lasts for at least three weeks (nine ECT sessions). Psychopharmacological treatment is continued during ECT treatment. Patients receive ultrabrief pulse (0.3 ms), unilateral treatment at a frequency of 40-100 Hertz. Stimulation is applied to the non-dominant hemisphere, according to the d'Elia electrode positioning paradigm. All patients are initially treated with right unilateral stimulation and in case of non-response switched to bilateral treatment. Stimulus intensity is chosen according to individual seizure threshold and administered at 2.5 to 6-fold intensity. During the ECT session, patients are anesthetized, under the influence of a muscle relaxant, and monitored regarding their vital functions.
- BEHAVIORAL
-
Cognitive behavioral group therapy
The continuation-psychotherapy (continuation cognitive behavioral therapy, C-CBT) sample took part in a newly developed cognitive behavioral group therapy program called "EffECTive". This therapy program was developed within the EffECT-project (Brakemeier et al. 2005), to fit the specific target group of patients finished with acute ECT-treatment. EffECTive is a group therapy that combines several aspects of existing cognitive-behavioral depression manuals with new elements (e.g., the situational analysis from CBASP, McCullough 2000), to fit the target group. Therapy sessions were held once a week and include approximately 15 sessions until follow-up.
Sponsors & Collaborators
-
German Research Foundation
collaborator OTHER -
Charite University, Berlin, Germany
lead OTHER
Principal Investigators
-
Malek Bajbouj, PhD · Department of Psychiatry, Charité University Medicine, Campus Benjamin Franklin, Berlin, Germany
-
Eva-Lotta Brakemeier, MA · Department of Psychiatry and Psychotherapy, University Medicine, Freiburg, Germany
-
Norbert Kathmann, PhD · Department of Clinical Psychology, Humboldt-University, Berlin, Germany
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-03-31
- Primary Completion
- 2010-03-31
- Completion
- 2011-03-31
Countries
- Germany
Study Locations
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