Psychotherapy Plus: Combining Cognitive Behavioral Therapy With tDCS
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder, Major
Study type: Interventional

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.
    

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.
    

Intervention name(s): cognitive behavioral therapy; tDCS; sham-tDCS
Intervention type(s): Behavioral; Device; Device
Intervention description(s): 12 sessions of group cognitive behavioral therapy, six patients, two therapists, duration: 100 minutes, two sessions per week for a total of six weeks; 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 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tDCS; cognitive behavioral therapy