Boosting Psychotherapy Effects by Means of Transcranial Direct Current Stimulation

NCT ID: NCT05866042

Last Updated: 2023-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2023-04-30

Brief 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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active tDCS

Administration of active tDCS, not followed by MCT session, but by a usual visit psychiatric follow-up

Group Type: EXPERIMENTAL

tDCS

Intervention Type: DEVICE

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.

sham tDCS and MCT

Administration of sham tDCS, followed by MCT session

Group Type: NO_INTERVENTION

No interventions assigned to this group

active tDCS and MCT

Administration of active tDCS, followed by MCT session

Group Type: EXPERIMENTAL

tDCS

Intervention Type: DEVICE

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.

Interventions

tDCS

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Ability to provide informed consent to study
• Ability to understand and speak the Italian language
• DSM-5 diagnosis of Major Depressive Disorder.
• Ongoing depressive episode of at least moderate intensity (HAM-D> 18)

Exclusion Criteria

• Previous tDCS sessions with significant side effects
• Positive personal history for seizures
• Positive family history for epileptic disease
• Positive personal history for neurological disease
• Positive personal history for head trauma with loss of consciousness
• Positive personal history for frequent and severe headaches
• Positive personal history for neurosurgical procedures
• Prior implantation of neurostimulation implants (DBS, VNS, etc.)
• Prior implantation of defibrillator or pace-maker
• Possibility of pregnancy or established pregnancy
• Substance or alcohol abuse in the past 6 months
• Positive personal history for schizophrenia or schizoaffective disorder
• Positive personal history of intellectual disability ("mental retardation")
• Current hospitalization
• Cardiac, respiratory, renal, hepatic failure, immunosuppression status

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, MI, Italy

Countries

Italy

Other Identifiers

PSYCHOBOOST

Identifier Type: -

Identifier Source: org_study_id