PsychotherapyPlus: Augmentation of Cognitive-Behavioral Psychotherapy with prefrontal direct current stimulation in Major Depression

Principal Investigator: Malek Bajbouj (Berlin)

 

Background and aims


Depression is globally among the most frequent disorders with a cumulated lifetime prevalence of 15 %. Despite recent advances in antidepressant therapies, a relevant number of up to 20% of all patients still do not respond sufficiently [16]. In those cases, non-invasive brain stimulation techniques (NIBS) are often seen as a third treatment pathway. There is accumulating evidence that NIBS of the prefrontal cortex does not only exerts global antidepressant effects (see WP7), but is also capable of focally enhancing, prefrontally mediated mechanism that in consequence may improve psychotherapeutic techniques such as emotional learning, emotion regulation strategies [7], or cognitive control [20]. Contrasting the strengths and weaknesses of the different treatment interventions, psychotherapeutic interventions are well tolerated [15], have slow response speed with low relapse rates whereas NIBS may evolve its strength in the first weeks of treatment while having relatively high relapse rates. Combining those methods based on recently identifies neural circuits, as proposed here, constitutes a promising way of combining the advantages of both treatment approaches and thereby augmenting psychotherapeutic strategies, and would finally be a major advance in the non-pharmacological treatment of depressive patients.

 

Working hypothesis


The aim of this workpackage is to investigate the efficacy and tolerability of prefrontal transcranial direct current stimulation tDCS used as an additive therapy to cognitive-behavioral psychotherapy as treatment for major depressionin a doble-blind, randomisized, placebo-controlled study.The target group of this study are patients suffering under Major depression who show intolerance toward antidepressant pharmacotherapy treamtment and/or announce a preference towards CBT.

Inclusion criteria:

  • unipolar major depression (DSM-5)
  • inadequate treatment with antidepressants due to intolerability (defined as a ATHF- level of 1-2) in the current episode or preference to psychotherapeutic treatment
  • Hamilton Depression Rating Scale score (21 items) ≥15, age 18-65 years

Exclusion criteria:

  • acute risk for suicide
  • other ongoing psychotherapy or psychotropic medication other than SSRI or mirtazapine
  • relevant psychiatric, neurological or medical comorbidity

The experimental intervention consists of 12 session of CBT (á 60 min) combined with tDCS within 6 weeks. The stimulation will be applied during the CBT session  with the following stimulation parameters: 2 mA, anode over electrode position F3, cathode over F4. 

 

Research Questions


Is CBT when combined with prefrontal transcranial direct current stimulation (tDCS) more efficacious as compared to CBT alone, tDCS alone, or sham?
The study design encompasses three treatment arms and one placebo arm.

Treament arms:

  • anodal left prefrontal tDCS (12 sessions in 6 weeks) with CBT
  • anodal left prefrontal tDCS (12 sessions in 6 weeks) without CBT;
  • sham tDCS plus CBT (12 sessions in 6 weeks);

Placebo arm:

  • sham tDCS (12 sessions in 6 weeks)

In order to evaluation the efficacy of the augmentation effect of CBT combined with tDCS there will be 3- and 6-month follow-up study visits.

 

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