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Psychotherapy Plus: Combining Cognitive Behavioral Therapy With tDCS

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ClinicalTrials.gov Identifier: NCT02633449
Recruitment Status : Recruiting
First Posted : December 17, 2015
Last Update Posted : July 13, 2018
Sponsor:
Collaborators:
University of München
University Hospital Tuebingen
University of Freiburg
University of Leipzig
Central Institute of Mental Health, Mannheim
Information provided by (Responsible Party):
Malek Bajbouj, Charite University, Berlin, Germany

Study Description
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Brief Summary:
The study will investigate whether cognitive behavioral psychotherapy (CBT) combined with prefrontal transcranial direct current stimulation (tDCS) is more efficacious with regard to symptom reduction in depressed patients than CBT combined with sham-tDCS or CBT alone.

Condition or disease Intervention/treatment Phase
Major Depression Behavioral: cognitive behavioral therapy Device: tDCS Device: sham-tDCS Not Applicable

Detailed Description:

Brain stimulation techniques are widely seen as promising treatment alternatives for patients not responding to or tolerating psychotropic medication. In particular, transcranial direct current stimulation (tDCS) is of special interest due to its potential to be used by a large number of patients because of its comparably ease of usage and good tolerability. Thus, a large number of studies investigating clinical effects of tDCS have been performed with statistically significant effects but that are of moderate clinical relevance. Clinical studies have mainly focused on the prefrontal cortex (PFC) as the main stimulation target based on findings of numerous studies indicating the lateral PFC to be a key dysfunctional node within brain networks involved in the pathophysiology of depression.

Studies in clinical and healthy participants indicate that tDCS is capable of positively augmenting prefrontal functions that are relevant for a successful cognitive behavioral therapy. More specifically, it has been shown that tDCS is capable of improving reappraisal strategies as well as the use of cognitive control techniques .

To date, previous studies have mainly addressed global antidepressant effects of tDCS and not effects on more circumscribed phenotypes mediated by top-down PFC processes such as impaired or biased emotional learning processes. All these trials have applied the stimulation to patients while being in a resting position. Nonetheless, recent neuropsychological studies indicate that tDCS effects appear to be "activity dependent", meaning that the stimulation effects are greater when the brain region being stimulated is simultaneously engaged in a cognitive task. Therefore, in the present study we will apply tDCS to patients with unipolar major depressive disorder during cognitive behavioral therapy (CBT), a well-established and highly effective psychotherapeutic treatment for depression.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Augmentation of Cognitive-Behavioral Psychotherapy With Prefrontal Direct Current Stimulation in Major Depression (Psychotherapy Plus)
Study Start Date : February 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: cognitive behavioral therapy + tDCS
Group cognitive behavioral therapy combined with tDCS
 Behavioral: cognitive behavioral therapy
12 sessions of group cognitive behavioral therapy, six patients, two therapists, duration: 100 minutes, two sessions per week for a total of six weeks

Device: tDCS
transcranial direct current stimulation during cognitive behavioral therapy with delayed onset after 10 minutes for 30 minutes, 1-2 mA, anode over electrode position F3, cathode over F4
Active Comparator: cognitive behavioral therapy + sham-tDCS
Group cognitive behavioral therapy combined with sham-tDCS
 Behavioral: cognitive behavioral therapy
12 sessions of group cognitive behavioral therapy, six patients, two therapists, duration: 100 minutes, two sessions per week for a total of six weeks

Device: sham-tDCS
sham transcranial direct current stimulation during cognitive behavioral therapy with delayed onset after 10 minutes for 30 minutes, anode over electrode position F3, cathode over F4
Placebo Comparator: cognitive behavioral therapy
Group cognitive behavioral therapy only
 Behavioral: cognitive behavioral therapy
12 sessions of group cognitive behavioral therapy, six patients, two therapists, duration: 100 minutes, two sessions per week for a total of six weeks


Outcome Measures
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Primary Outcome Measures :
  1. Change in depression severity as measured by Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 6, 18 and 30 weeks after randomization ]
    MADRS ratings by trained clinicans, comparison between MADRS at baseline to MADRS post intervention, group comparison: treatment group vs. the two control interventions.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- unipolar major depressive disorder

Exclusion Criteria:

  • neurological diseases or relevant psychiatric diseases other than major depressive disorder
  • current medication other than SSRI or Mirtazapine
  • manic episodes (lifetime)
  • psychotic symptoms (lifetime)
  • treatment with psychotherapy within the past 2 years
  • treatment with electroconvulsive therapy (lifetime)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633449


Contacts
Contact: Malek Bajbouj, Prof. Dr. +4930450517542 malek.bajbouj@charite.de
Contact: Sabine Aust, Dr. +4930450517779 aust.sabine@charite.de

Locations
Germany
Charité University Medicine Berlin, Department of Psychiatry and Psychotherapy Recruiting
Berlin, Germany, 12203
Contact: Sabine Aust, Dr.    +4930450517779    psychotherapie-plus@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
University of München
University Hospital Tuebingen
University of Freiburg
University of Leipzig
Central Institute of Mental Health, Mannheim
Investigators
Principal Investigator: Malek Bajbouj, Prof. Dr. Charite University, Berlin, Germany
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Malek Bajbouj, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02633449     History of Changes
Other Study ID Numbers: 01EE1403F
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

Keywords provided by Malek Bajbouj, Charite University, Berlin, Germany:
tDCS
cognitive behavioral therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders