Boosting Psychotherapy Effects by Means of Transcranial Direct Current Stimulation
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The present study involves the administration of three types of interventions in patients
      with depressive episode in the context of DDM. Two-thirds of the patients will carry out a
      course of excitatory tDCS sessions on the left DLPFC, so as to improve attention regulation
      on information characterized by negative emotions and have an antidepressant effect,
      simultaneously with the performance of a task, the attentional training technique (ATT),
      aimed at achieve effective management of emotions characterized by negative emotions and
      which constitutes a fundamental exercise of MCT. In half of the patients who will undergo
      tDCS treatment, after each session of stimulation, an MCT session will be carried out. In
      addition, before and after the cycle of tDCS sessions and MCT sessions will be explored, in a
      subgroup of patients, in the context of a pilot study, the TMS- EEG of the change in
      depressive symptomatology, which can be correlated with the different proposed therapeutic
      interventions.
    

Detailed description: 
      The study - interventional, nonpharmacological, using medical devices, nonprofit - is aimed
      at evaluating the potential effectiveness of a multimodal intervention for the treatment of
      unipolar depression. The intervention involves the use of a neuro-stimulation technique, the
      Transcranial Direct Current Stimulation (transcranial Direct Current Stimulation - tDCS),
      combined with a psychotherapy intervention, metacognitive therapy (MetaCognitive Therapy,
      MCT). TDCS is a noninvasive neurostimulation technique involving the transcranial application
      of a low-amperage electric current at a region of the cerebral cortex involved in the
      pathogenesis of major depression, the dorsolateral prefrontal cortex. It has been
      demonstrated how such stimulation has a neuromodulating effect on synaptic plasticity, with
      efficacy in unipolar major depression. The technique also has a good safety, as it is not
      associated with major side effects. MCT is based on the metacognitive model, according to
      which psychopathological processes are consequent to a cognitive style characterized by
      repetitive forms of thinking (such as rumination) and maladaptive behaviors such as avoidance
      and thought suppression. The MCT, through attention training techniques, detached mindfulness
      and behavioral interventions on metacognitions, has shown effectiveness in major depressive
      disorder comparable to that of psychotherapeutic interventions considered, within
      psychotherapies, to be first-line such as cognitive-behavioral therapy. The experimental
      design will be that of a randomized, double-blind study with three arms of treatment, each
      consisting of 8 sessions, involving the administration of 1) the neurostimulation
      intervention (tDCS), 2) of the psychotherapeutic intervention alone (MCT), 3) of both
      techniques in consecution (tDCS-MCT). This design is aimed at evaluating a potential
      additive/synergistic effect of the two interventions when combined. During the tDCS sessions,
      each lasting 20 minutes, the patient will apply the technique of attention training, aimed at
      further activating the region stimulated by neurostimulation, so as to so as to amplify the
      plasticity stimulated by tDCS, achieving a synergistic effect. To follow, a 40-minute MCT
      session will be carried out. The effectiveness of these interventions will be assessed by
      heteroadministered and self-administered at time zero, after treatment, at two follow-ups of
      6 and 12 months. Before and after the treatment cycle (tDCS sessions and MCT sessions), a
      subgroup of patients will be explored, in the context of a pilot study, the TMS-EEG
      correlates of the change in symptomatology depression, which can be correlated with the
      different proposed therapeutic interventions.
    

Intervention name(s): tDCS
Intervention type(s): Device
Intervention description(s): TDCS is a noninvasive neurostimulation technique involving the transcranial application of a low-amperage electric current at a region of the cerebral cortex involved in the pathogenesis of major depression, the dorsolateral prefrontal cortex. In healthy subjects, the administration of excitatory tDCS on the left DLPFC improves the regulation of attention on information characterized by negative emotions, as does the administration of inhibitory tDCS on the DLPFC Right tDCS produces small changes in the neuronal membrane potential, thus increasing or decreasing the excitability of the stimulated tissue. Simultaneous administration to behavioral tasks designed to activate the stimulated cortical region should achieve a synergistic, amplifying the plasticity stimulated by the task.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment