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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 : August 22, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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
Major Depression Behavioral: cognitive behavioral therapy Device: tDCS Device: sham-tDCS

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

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 : August 2017
Estimated Study Completion Date : August 2018
Arms and Interventions

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: 60 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: 60 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: 60 minutes, two sessions per week for a total of six weeks


Outcome Measures

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)
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

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
Investigators
Principal Investigator: Malek Bajbouj, Prof. Dr. Charite University, Berlin, Germany
More Information

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: August 22, 2017
Last Verified: August 2017

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