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Completed

NCT Number: NCT02633449

Psychotherapy Plus: Combining Cognitive Behavioral Therapy With tDCS

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité University Medicine Berlin, Department of Psychiatry and Psychotherapy

Berlin, 12203, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cognitive behavioral therapy

Behavioral

12 sessions of group cognitive behavioral therapy, six patients, two therapists, duration: 100 minutes, two sessions per week for a total of six weeks

tDCS

Device

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

sham-tDCS

Device

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Central Institute of Mental Health, Mannheim
  • University Hospital Tuebingen
  • University of Freiburg
  • University of Leipzig
  • University of München

Registry information

Official study title

Augmentation of Cognitive-Behavioral Psychotherapy With Prefrontal Direct Current Stimulation in Major Depression (Psychotherapy Plus)

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Dec 17, 2015
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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