Boosting Psychotherapy Effects by Means of Transcranial Direct Current Stimulation

NCT05866042 | Completed

• 1 other identifier: PSYCHOBOOST
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• to evaluate the potential superiority, from the point of view of therapeutic efficacy in depression, of the approach of combined administration of tDCS and MCT, compared with interventions based tDCS alone or MCT alone.

  Change in the Hamilton Depression Rating Scale will be used as parameters, during follow-up (end of treatment, 1, 3, 6 and 12 months).

  end of treatment, 1, 3, 6 and 12 months

Secondary Outcomes (1)

• To evaluate the TMS-EEG correlates of change in depressive symptomatology, correlating them with the different proposed therapeutic interventions, in a subgroup of patients recruited, in the context of a pilot study.

  12 months

Study Arms (3)

Active tDCS

EXPERIMENTAL

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

Device: tDCS

sham tDCS and MCT

NO INTERVENTION

Administration of sham tDCS, followed by MCT session

active tDCS and MCT

EXPERIMENTAL

Administration of active tDCS, followed by MCT session

Device: tDCS

Interventions

tDCS 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.

Active tDCS; active tDCS and MCT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, MI, 20100, Italy

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 19, 2023
• Study Start: May 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2023
• Last Updated: May 19, 2023

Record last verified: 2021-05

Locations

IT (1)